Description
this report is my summer internship report on the subject dispatch and import - export. apart from all the details about import and export this report is also consist an overview of all the departments of the company and their functions
Dispatch & Import Export
-A summer internship report (June-July 2011)
Guided By: Mr. Jigneshkumar Soni Prepared By: Nikul G Moradiya (10066) Master of Business Administration 2010 12
Submitted To: Unimed Technologies Limited
G H Patel Post Graduate Institute of Business Management 9/7/2011
I.
PREFACE
Pharmaceutical industry is one of the highest growing industries in India and this report presents a live picture of one such leading organization in the same industry: Unimed Technology Limited. This report is divided in two parts. Part:-1 It introduces all the departments of the organization and their functions.
Basically it is just an overview with enough details so that any person, reading this report might fill him/herself acquainted of the pharma industry. There are many jargons and technical details used in this report because to know about the pharma company, any person (either science or non science background) must go through at least this much of details. Part:-2 this part presents the core subject of my summer internship. Here the complete
process and all possible details of IMPORT ± EXPORT and DISPATCH are given. Reader may find a bit typical law language in this part. I have tried my best to translate this language in simple form without omitting important details and modification of meanings. Almost all the laws and change in rules related to import ± export has been covered. Documentation is the most important part of import ± export process. This report covers detailed information about the all required documents and possible samples of documents are also attached.
2
II.
ACKNOWLEDGEMENT
I have taken efforts in this project. However, it would not have been possible without the kind support and help of many individuals of Unimed Technologies Limited. I would like to extend my sincere thanks to all of them. I am highly indebted to Mr. JIGNESHKUMAR SONI, Head; BSR/UTL for their guidance and constant supervision as well as for providing necessary information regarding the project & also for their support in completing the project. I would like to express my gratitude towards Mr. Pushpendrakumar Jain Mr. Ajit Thakor Mr. Jagat unadkat Mr. Bhagvan Nehate Mr. Rameshchandra Joshi Mr. Ashim Tendulkar Mr. Nilesh Bhatt Mr. Vijay Kashyap Mr. Sameer Shah General Manager, Operations Head, Personnel and Administration Assistant manager, production Head, production Assistant manager, engineering Head, Engineering Head, Quality Assurance Head, Quality Control Assistant manager, Store
For their kind co-operation and encouragement which help me in completion of this project. I would like to express my gratitude and thanks to all of them for giving me such attention and time.
3
INDEX
Page No.
Preface Acknowledgement Part I An overview of Indian pharma industry Personnel & Administration department Engineering department Production department Packaging department Quality Assurance & Quality Control department Part II Warehouse department Dispatch Import Export Attachments
2 3 5 9 14 20 27 29 36 41 45 50 69
4
An Overview of Indian Pharma industry
The Indian Pharmaceutical Industry today is in the front rank of India¶s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. Playing a key role in promoting and sustaining development in the vital field of medicines, Indian Pharma Industry boasts of quality producers with many units approved by regulatory authorities in USA and UK.
Domestic Market: US $ 7bn
Export: US $ 5bn
Total: US $ 12-13bn
Contract manufacturing -JV/Alliance -competition from China
Domestic formulation -IPR regime -pricing pressure on old molecules -brands differianted products
Generic business
Indian pharma
-Increasing competition -Prising pressure -Acquisition -aggressive build up of products
-ANDA/NDDS/NEC -Out Licensing -High Investment / Long Gestation
5
Indian pharma sector: Growth Scenario in 2010 Third in the world in terms of volume. Rank is 14th in terms of value. The domestic market was worth US$ 12.26 billion. Market reached US$ 10.04 billion in size in July 2010. The Indian Pharma Industry is estimated to be worth $ 4.5 billion Growing at about 8 to 9 percent annually.
KEY OPPORTUNITY SEGMENTS
Manufacturing opportunities
Manufacturing opportunities
Indian pharmaceutical industry
Innovation opportunities
Contract research
Leading Pharmaceutical Companies
6
In the domestic market, Cipla retained its leadership position with 5.27 per cent share. Ranbaxy followed next. The highest growth was for Mankind Pharma (37.2%). Other leading companies in the Indian pharma market in 2010 are
y y y y y y y y
Sun Pharma (25.7%) Abbott (25%) Zydus Cadila (24.1%) Alkem Laboratories (23.3%) Pfizer (23.6 %) GSK India (19%) Piramal Healthcare (18.6 %) Lupin (18.8 %) The Indian pharmaceuticals market is expected to reach US$ 55 billion in 2020 from US$ 12.6 billion in 2009. This was stated in a report title "India Pharma 2020: Propelling access and acceptance, realising true potential" by McKinsey & Company. In the same report, it was also mentioned that in an aggressive growth scenario, the pharma market has the further potential to reach US$ 70 billion by 2020
Due to increase in the population of high income group, there is every likelihood that they will open a potential US$ 8 billion market for multinational companies selling costly drugs by 2015. This was estimated in a report by Ernst & Young. The domestic pharma market is estimated to touch US$ 20 billion by 2015. The healthcare market in India to reach US$ 31.59 billion by 2020. The sale of all types of pharmaceutical drugs and medicines in the country stands at US$ 9.61 billion, which is expected to reach around US$ 19.22 billion by 2012. Thus India would really become a lucrative destination for clinical trials for global giants.
7
Unimed Technologies Limited
Unimed has been established in the year 1990. Company¶s production plant is situated above 36 Km east from VADODARA & 6 km away from HALOL. Unimed is one of the leading companies, having an asset of its quality products. Unimed works under loan license of SUN pharma. Unimed is producing Parenteral, Ophthalmic and Hormone products. Currently company is producing more than 100 products. Few well known Unimed products are Cardiject injection Careprost Depopred Eyemist Fertigyn Ivepred Letoprost Lupride depot Ocepred, etc. Unimed is also preparing to launch its new plant for production of ANDA ³Abbreviated New Drug Application´. This plant is constructed according to US FDA guidelines. UTL has also constructed a gas based power plant to become self-reliable.
8
Part - I
1. Personnel & administration
The meaning of HR is Human Resource but at the Unimed it¶s also stands for Happy Relations. The human resource department of the company deals with employment, recruitment and placement. It also takes care of employer-employee relations, compensation benefits and training & development. The role of HR is not only managing the human resource but also it is a strategic business contributor. It is not worthless to say that HR provides the support to management in accomplishing the original objectives. Intellectual management or human resource management in this transition phase is handling by HR.
ORGANOGRAM OF UNIMED TECHNOLOGIES LIMITEDLIMITED
9
HOD of each department is supported by cluster of subordinates and we can present them in form of hierarchical chart as per below«..
This kind of organized structure of manpower always produces the desired results and pushing forwards the organization towards the achievement of objectives.
10
1.1.
Recruitment process
There are ten ways for not to do the work, but there is only one way to do the work. Probably this saying is worth for any employee in any organization. The recruitment and selection is the major function of the human resource department and recruitment process is the first step towards creating the competitive strength and the strategic advantage for the organizations. Recruitment process involves a systematic procedure from sourcing the candidate to arranging and conducting the interviews and requires many resources and time. At the Unimed recruitment process is conducted by the very experienced team of HR specialists and professionals from other departments. The whole process can be described in few simple steps.
11
Identify vacancy
Jo b description and job specification
Search resume relevant to job Scrutinization of resume Arrange interviews Conduct interviews Final selection Appointment process
1.2. Training process a. Induction b. General QA system training c. Departmental SOP training d. On Job Training e. GMP f. Evaluation g. Qualification and approval
12
1.3.
Appraisal
People differ in their abilities and their aptitudes. There is always some difference between the quality and quantity of the same work on the same job being done by two different people. Performance appraisals of Employees are necessary to understand each employee¶s abilities, competencies and relative merit and worth for the organization. Performance appraisal rates the employees in terms of their performance.
Performance appraisals are widely used in the society. An employer evaluating their employees is a very old concept. Performance appraisals are an indispensable part of performance measurement.
The latest mantra being followed by organizations across the world being "get paid according to what you contribute" the focus of the organizations is turning to performance management and specifically
to individual performance. Performance appraisal helps to rate the performance of the employees and evaluate their contribution towards the organizational goals.
Performance appraisal takes into account the past performance of the employees and focuses on the improvement of the future performance of the employees.
1.4.
Motivation
En employee can be compared with the milking cow. If they would be taken care of (economically and emotionally) then they will produce the best outcome. At the Unimed employees are being awarded regular increments as well as promotions to superior designation as per their work experience and commitment towards the organization. Apart from money factor, employees are regularly undergoes to medical checkup which shows commitment of organization towards the employees. Employees are also having enough sick leaves, paid leaves and casual leaves which transforms into a unique working experience without disturbing social life of individual.
13
2. Engineering
RO PW
WFI
Generator GEB supply
14
2.1.
Water supply
The natural water contains solid, liquid and gaseous impurities and therefore, this water cannot be used in process. The impurities present in the water cannot be removed before its use. The necessity for reducing the corrosive nature & quantity of dissolved and suspended solid s in the feed water has become increasingly important with advent of utilities or process application.
2.1.1. Impurities in water:
The impurities present in the feed water are classified as given below,
Impurities in water
Un-dissolved and suspended solid materials. Turbidity & sediments Sodium and potassium salts Chloride Iron Manganese Silica Microbiological growth Color
Dissolved salts and minerals
Other minerals
Dissolved gases
calcium salt magnesium salt
free mineral acid oil
CO2 O2
2.1.2. Reverse osmosis process
The reverse osmosis system is composed of two major parts: the high pressure pump and the membranes. The initial purified water production rate is measured at this pressure. It appears that there are longer-term benefits to be gained by operating at lower percent water recovery, particularly in reducing maintenance to the systems, and maintaining precipitation problems,
15
which may arise due to operator error. It is important to realize that the purified water from a reverse osmosis system is delivered essentially at atmospheric pressure, usually to a vented storage tank. In general, it cannot be operated by opening and closing a valve in the product water lines (unless special pressure relief is provided). The reason for this is that the high pressure in the system drives the water across the membrane, and no flow of water would be possible if the pressure on both sides of the membrane were the same. If for some reason, the product water line was closed while the system was operating. The pressure would build up. Of course, if the purified waterside off the system were strong enough, the problems, which may arise due to operator error, would be minimized.
2.1.3. Process chart
Utility area
16
2.2.
Air System
Air supplied by the engineering unit is of two types: HVLP (High Volume Low Pressure) air & LVHP (Low Volume High Pressure) air. HVLP is maintained through Air handling Unit (AHU) and LVHP is used as compressed dry air.
Air Handling Unit
AHU is a device used to condition and circulate air as part of a heating, ventilating, and airconditioning system. It is usually a large metal box containing a blower, heating or cooling elements filter racks or chambers, sound attenuators, and dampers. Air handlers usually connect to ductwork that distributes the conditioned air through the building and returns it to the AHU. Sometimes AHU discharge (supply) and admit (return) air directly to and from the space served without ductwork. The air handling unit affects to the temperature and humidity inside the building. In this case the control is based on several principles. The supply air temperature is kept constant to allow the adjustment of temperature in each room with separate thermostats or dampers. The supply air humidity must not exceed a certain level. Also the circulation of air should always be sufficient.
AHU components
Blower/ fan Heating and/or cooling elements Filters Humidifier Mixing chamber Heat Recovery Device Controls Vibration isolators
17
High efficiency particulate Air (HEPA)
HEPA filters are composed of a mat of randomly arranged fibers. The fibers are typically composed of fiberglass and possess diameters between 0.5 and 2.0 micrometer. Key factors affecting function are fiber diameter, filter thickness, and face velocity. The air space between HEPA filter fibers is much greater than 0.3 m. The common assumption that a HEPA filter acts like a sieve where particles smaller than the largest opening can pass through is incorrect. Unlike membrane filters, where particles as wide as the largest opening or distance between fibers cannot pass in between them at all, HEPA filters are designed to target much smaller pollutants and particles. The particles are trapped (they stick to a fiber) through a combination of the following three mechanisms: 1. Interception, where particles following a line of flow in the air stream come within one radius of a fiber and adhere to it. 2. Impaction, where larger particles are unable to avoid fibers by following the curving outlines of the air stream and are forced to embed in one of them directly; this effect increases with diminishing fiber separation and higher air flow velocity. 3. Diffusion, an enhancing mechanism is a result of the collision with gas molecules by the smallest particles, especially those below 0.1 µm in diameter, which are thereby impeded and delayed in their path through the filter. HEPA filter remove at least 99.97% of airborne particles 0.3 micrometers (µm) in diameter.
18
Nitrogen plant
1. It is used in pre & post filling of parenteral products. 2. Also used in pre & post integrity test of filter.
Ai r (78% N2 + 21% O2 + 1% other gases BLOWER Pass through CMC material, absorb O2
Nitrogen gas (NMT 0.5% O2)
ETP (Effluent Treatment Plant)
All hazardous waste will be processed at Nandesari common disposal plant and then release waste by converting in non-hazardous
Water of plant sewage Add alum, 2 layers will be separate out
Upper layer will be re-used Lower layer would be rejected
19
3.
PRODUCTION
Production is a functional area responsible for turning inputs into finished outputs through a series of production processes. The production manager is responsible for making sure that raw materials are provided and made into finished goods effectively.
Chemist room
It is an area where all workers, machine operators and officers meet daily at the starting time of their respective shift to plan complete schedule and allocate work activities. In the room one white board displays 1 month projected manufacturing schedule of production department in following format. Sr, no. Mfg. date Filling date 1 15/05/2010 16/05/2010 Product name Lotepred LS 2 16/05/2010 16/05/2010 Tropicamet HKMJ0513 100 literr Export HKMJ0522 200 liter Domestic Batch no. Batch size Remarks
Label of Batch in Process BATCH IN PROCESS DATE:__/__/201 PRODUCT NAME BATCH NUMBER BATCH SIZE MANFAACTURING SIZE EXPIRY DATE STAGE CHECKED BY
20
3.1.
SOP (Standard Operating Procedure)
It is a document which prescribes an ideal procedure for each & every activity of company. It strictly follows GMP (Good Manufacturing Practice)
Content of SOP:
Sr. no. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Title Title CC No. Supersedes Effective date Purpose Scope Reference Attachment Annexure Distribution Definition of terms Procedure History Stamp Description It is expressive of subject of SOP Change control number Mention previous SOP number Date on which SOP become effective Mention intended use of SOP Application of SOP Detail of any reference used Desired supportive documents attach with SOP Documents serve as informative guidance Area in which copy will be send to department Define in Lehman language, easy for understanding Systematic procedure as per GMP Any previous incident or abnormalities In represent green colored stamp and copy number
As per the suggestions of WHO (World Health Organization) Unimed also translate all SOP¶s in vernacular language (Gujarati) for easy understanding of workers and operators.
3.2.
BMR (Batch Manufacturing Record)
It is a file which contains all the details of batch starting from raw material receiving to finish good dispatch. BMR preserved for 1 year more than expiry date of batch
21
Content of BMR
Sr. no. 1 2 3 4 5 6 7 8 9 10 11 12 Title Product name Generic name Strength BMR status Effective date Supersedes CC no. Batch size Material pick up list Master formula Signature log Verification sheet Sr. no. Title 13 14 15 16 17 18 19 20 21 22 23 Washing of PPM Mfg process detail Filtration detail Filling detail Sterilization detail Calculation Accountability % Yield % Visual inspection record History date Cycle time
3.3.
Introduction to areas of production department
a. De cartooning area
Here primary packing materials like ampoules and vials are received. Workers arrange ampoules or vials into perforated plate which are directly sent to washing area through hedge. There would be normal pressure and room temperature would be maintained.
b. Ampoules / Vials washing area
In this area ampoules and vials are being washes in two step process 1. Inner wash: by help of purify water, water for injection and compressed air one by one. 2. Outer wash: by help of purify water & water for injection one by one. Temperature of washing area should NMT 27o C & pressure NLT 0.4 mm of WC. (WC = water column)
22
c. Equipment washing area
Here parts of equipment or tanks has to be cleaned with help of purify water and then water for injection. Temperature of washing area should NMT 27o C & pressure NLT 0.4 mm of WC (= water column)
d. Dress washing area
Equipment has capacity to process 30 pairs of dress at once. Normal room temperature and humidity would be maintained here. e. Autoclave & DHS (Dry Heat Sterilization) area Material or equipments used for preparation of parenteral products must pass through autoclave or DHS, for sterilization. This process leads to denaturation of protein of bacteria, results in death of bacterias. Autoclave wiil lead to coagulation of protein of bacteria. It has temperature NMT 27o C & humidity NMT 55%. Temperature will be automatically recorded and printed at regular interval of 3 minutes.
f. Manufacturing area
Here active ingredients & excipient of final product have been mixed according to procedure of BMR. Manufacturing area has to send in process sample of 30 ml for approval of QC department. In this area temperature, humidity, pH order of mixing and other parameters has to be followed strictly.
g. Filtration area
Bulk solution or suspension is filtered through membrane or cartilage filter by help of nitrogen gas with pressure of 0 to 2 Kg/cm2.
23
Efficiency of filter is calibrated by bubble point test.
h. Filling and capping area
In filling area product is filled in respective containers. There are 3 different types of filling tube stainless steel, glass & silicon. Initial 5 vials or ampoules have been discarded in following cases: Initial machine startup Completion of maintenance work Replacement of syringe & needle Shift change Tube filling machine- Unimed has only one product ³Eye mist Gel´ in tube form. It has 1 head. Output rate is 30 tubes / min.
i.
Visual inspection area
In this area every ampoules or vials have been checked by trained workers manually. Workers are given target based work. Each worker has to submit eye report from government hospital. Company takes on test for 100 ampoules, in which qualifying criteria is 97% accuracy. Visual department also maintain several records. i.e. temperature measurement record, sequential log sheet, daily visual inspection record, etc.
j. Freeze dry area
It works on principle of ³Lyophilization & Sublimitation´. This process has capacity to remove moisture from product by converting moisture in ice and then directly convert to vapor by passing liquid stage. Lupride Depot is freeze dried product and it Unimed is only manufacturer of this product in India.
24
k. Quarantine area
After completion of visual inspection, products are placed in this area. from this area, packing department will receive products for labeling & secondary packing with help of ³Batch transfer note´ There are different color codes for different stages of products. Purpose of color code is to identify product at each & every stage and to avoid a mix up of materials. Sr. no. 1 2 3 4 5 Color code Yellow Pink Orange Blue Red Stage of product Ready for packing Ready for visual Ready for leak test Ready for sterilization Ready for rejection
Format of label: UNDER PROCESS APPROVAL DRUG NAME STAGE BATCH CODE MFG DATE CONTAINER NO. BARCODE HKNJ0555 05/2010 VISCOMET INJ 5 ML READY FOR VISUAL INSPECTION BATCH SIZE EXP DATE 1 OUT OF 50 100 LT 04/2012
25
3.4.
SR. NO 1 2 3 4 5 6 7 8 9 10
Capacity of equipments
EQUIPMENT Autoclave DHS 2592 lit. 972 lit. 1800 lit. 2500 lit. 7000 units / hr. Ampoule filling machine Bottle filling machine Lyophilizer Vial filling line Pre filled syringe machine Tube filling machine 80 units / min. 200kg. ice condensation 6000 units / hr 4000 units / hr 6000 units / hr 60 units / hr CAPACITY
26
Packaging department
There are 6 different types of packing line in the packing department 1. Plastic bottle packing line 2. Vial packing line 3. Ampoules packing line 4. Multipack show box over wrapping packing line 5. Single pack show box over wrapping packing line Layout of packing department quarantine:
READY FOR PACKING
PART BATCH
PACKED BATCH
COOLER NO. 1 COOLER NO. 1
ENTRY & EXIT
SHREDDER MACHINE
BPR (Batch Packing Record): It is a file which contains all details of packing materials like batch number, type of label, show box, ply box, corrugated box, etc.
27
Content of BPR: Sr. no 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Title Product name Generic name Strength (content of API) BPR status(tentative, final or scale up) Effective date Supersedes CC No. Batch size Signature log Bill of material Verification sheet Calculation sheet History date Cycle time
28
4. Quality Assurance Quality Control
Introduction
Quality department ensures that quality is built in the product through implementation of quality assurance system & procedures. Quality department is responsible for ensuring safety, identity, strength, purity and quality of each product manufactured at UTL.
Quality Assurance
Below mentioned activities comes under the responsibility of quality assurance department Ensuring in process control Raw material and packing material control Batch record review Finished product approval Release finished product for sale/export Process validation Equipment qualification Cleaning validation Change control programme Event and incident investigation procedure Document control Self inspection
29
Training Handling of market complaint Vendor evaluation Factory hygiene
Quality control
Testing and compliance of the raw material & packing/packaging material to approved specifications. Compliance of in-process & validation samples to approved specifications. Compliance of finished product to approved specifications.
QC insures quality system like
Stability study Analytical method validation Microbial purity control
Quality objectives To insure strict adherence to SOPs (standard operating procedure) and cGMP in conformity with WHO, various national and international standard To audit the system against actual practices To insure defined quality procedure To train all department supervisors for good documentation practices.
30
Activity flow chart
Receipt of raw and packing material
Sampling
Analysis
Approval of material
Rejection of material
BMR/BPR Issuance
Transferred to rejection area
Dispensing of raw material
Return to vendor
Disposal of material
Manufacturing
In process checks
In process sampling
QC analysis
Reprocessing
Intermediate stage release
BMR review by QA
Bulk preliminary approval by QA
31
Finished product sampling
Packing in process check Control sample/ stability sample withdrawal QC release Final release by QA Batch rejection
Review of batch record by QA
Transferred to BSR Batch destruction
32
Quality system
Document Mfg. and control
Validation
Qualification matrix
Training
Monitoring system
Audit program
Change control
Planned modification
Event investigation
Market complain
Product recall
Risk management
Annual product review
Out of specification
Vendor qualification
Quality management review
33
Validation
Process
Cleaning
Analytical method
Computer system
Protocol preparation
Protocol review
Protocol approval
Execution work
Report
Evaluation
Not satisfactory
Satisfactory
Change
Approval
Revalidation
34
Part II
Dispatch and Import - Export
35
5. WAREHOUSE
All the activities in the warehouse can be shown in the form of a diagram given below.
Receipt of raw materials and packing materials
Storage
Dispensing of raw materials
Issuance of packing material and raw material
Receipt of finished goods in BSR
Packing of cold chain products with coolant bags
Dispatch of finished goods
36
RECEIPT AND HANDLING OF RAW MATERIAL On receiving intimation from gate by security in-charge regarding any receipt of raw material, the following matters/details are required to be verified on the basis of supplier¶s bill challan. Then supplier¶s bill/challan would be checked, whether the material is for our location, if yes then material would be allowed inward. Security will take entry in inward register and allow vehicle inside the factory. The security incharge will put the reference of the inward entry on the backside of the supplier¶s bill/challan/LR (lorry receipt) STORAGE OF RAW MATERIAL Checks and precautions Storage all the liquid raw materials on the lower most rack. Store the heavy containers at lower level of rack. All the raw materials are to be stacked in proper rows, so that movement of the materials at the time of issuance is easy. Quarantine area Store QUARANTINE materials in this area which are identified by yellow colored border dedicated area/covered with nylon net/yellow rope (if applicable) with ³Quarantine´ coupon. Try to store single consignment on one pallet, if consignment is large, use required number of pallets ensuring proper segregation. Use separators in between for stacking different material on single pallet. Approved area Store all approved materials in this area, which are identified by green colored ³Approved´ label. Rejected area Store all rejected materials in this area which are identified by red colored ³Rejected´ label Storage area Store all the raw materials in the area with respect to their storage conditions as per the list given by QC. The various storage area available are Temperature range Less than 2o C Less than 25o C Room temperature Storage area Cold storage/refrigerator/cooling cabinet A.C. store room Respective location/ store room
37
Depending on the status of materials like Quarantine/approved/rejected transfer the material to its respective location. Whenever any non compliance is observed at any stage, inform the QC department for defacing the approved label and affix the HOLD label if required. In such cases where the non-compliance is observed for limited packs / containers instead of whole lot, the same should be transferred to Quarantine area after affixing HOLD label. Necessary entries should be updated in ERP for the same. After shifting the raw material to their respective location, update the locator code in the ERP system and thereafter also whenever material is shifting from one location to another or one rack to another, update the ERP system likewise. Whenever any material (in-out) from (2o to 8o) refrigerator and (-14oC to -25oC) deep freezer like for dispensing or sampling or any reason to be note down the entry in log book register.
ISSUANCE OF PACKING MATERIALS & RAW MATERIALS Material pick up list is submitted by user department for which work order is released for issue of packing material. Procedure for issuance of packing material Do not open sterile material outside of sterile area. All packing materials which are to be issued against MIO must contain approved labels Issue material and affix packing material issue coupon. Arrange issued material on clean pallets. Counter check with material issue order. Scan barcode before issuance of primary and secondary material. Confirm MIO, print MIO Deliver issue material with confirm MIO. Ensure that all packing material are identified by properly affixing issue coupon dully filled and signed and one set to be attached with confirmed MIO for user department. Guidelines Count all material like aluminum scales, non RFS rubber stopper by multiplying the qty. mentioned by supplier for each packets and for loose quantity count the same on the basis of average weights. Sterile plastic bottles, plugs and RFS rubber stopper is to issue as per material issue order. Issue intact packets in round of qty.
38
Count all material by multiplying the qty. mentioned by supplier for each packets and for loose quantity by physical counting of each item. For issuance of labels, intact role of label issue as mentioned supplier¶s label quantity and count all loose label on label counting machine.
DISPENSING OF RAW MATERIALS Store department will receive material pickup list along with BMR from the production department. System generates material pickup list on first expire first out basis. If ERP system is not working than production will give manually request with authorization along with BMR. Access articles option in the MIO for the number of RM coupons required in ERP system. Material issue coupons will be printed out as per requirement. Raw material will be picked up according to material pickup list. Ensure that all materials having ³approved´ labels. Materials of one product will be collected at a time and arranges properly in staging room. Collect the partially dispensed containers (loose) first, for dispense and keep the material on the pallet. Reverse laminar airflow shall be switched on before half an hour before starting dispensing and pressure has to be within the limit. RLAF and dispensing room shall be clean. Balances should be calibrated before use. Temperature not more than 30oC and humidity not more than 65% (or as specified in BMR) [Process: Material from staging room will be bought to dispensing room one by one for weighing. Gross weight of raw material will be checked before starting of each dispensing and record the same in raw material bin card. Scan the bar code. Wear clean and protective apparels. Change plastic gloves after dispensing each material.]
39
Other responsibilities
1. Handling of return material from production Material can be returned in following conditions y Dispensed material but manufacturing planning changed and returned to warehouse. y In case material is returned as online rejection due to not meet the requirements. y In case of excess packing material return. All return material store as per defined storage condition & locator code defined in material return coupons. Confirm the material return memo, print, sign & give to user department. 2. Handling of rejected materials. 3. Handling of spilled materials. y In case of spillage inform the QA. y In case of liquid spillage material would be handled as per MSDS (Material Safety Data Sheet) y In case of solid material, workers will collect the material in poly bag, affix the label of spillage and send it to ETP (Effluent Treatment Plant) for disposal. y In case of organic material spillage approved absorbent will be used for absorbing. y Spillage report will be prepared and authorized by quality head, department head and plant head. 4. Handling of damaged goods. y First of all intimate the quality assurance for spot observation through ³intimation fir damaged consignment/containers.´ y During the QA examination if material will be rejected then it would be treated as mentioned earlier. y Rejected material must contain label of ³rejected in spot observation´ y If the consignment/containers are to be rejected, return it back to the supplier. y If QA recommend to redress the material then redress it in dispensing area under QA supervision. y Redress the material in suitable container and record the data. Affix the redressing label on container with having all the details of original container. If possible than retain the original label. The dully filled redressing form signed by warehouse and QA officer shall be attached with goods inward memo. y A GIM will be prepared with the remark of spot observation and would be sent to QA department.
40
6. Dispatch
At the Unimed a standard procedure for dispatching is being followed strictly. This procedure ensures the quick dispatch of finished products into the market within very less time after the manufacturing of product. Warehouse receives RFC (Rolling Forecast) every month from the corporate. RFC is a list of products to be dispatched in the month. The same RFC is also sent to the production department for manufacture planning during the month. The whole dispatching process can be shown in form of a simple chart given below
Documentation
41
Meanwhile the dispatching process proceeds, documentation process will also proceeds simultaneously. The list of required documents is given below.
Details of documents for dispatch of finished goods:
Name of document 1 2 3 4 5 6 7 Excise bill in duplicate Stock transfer note Form 402 Form AR-2 for state excise product Lorry receipt Original and triplicate of out pass Form ARE-1 / ARE-2 / AR-4 for export ERP ERP Printed form Printed form MS Excel / open Office, signed by excise inspector Transporter Warehouse Printed form MS Excel / open Office, signed by excise inspector wherever applicable Document source
More ERP based documents 1. QC order 2. Distribution Order 3. Distribution Issue Above mentioned documents are not require to send with dispatched goods, but they are the part of standard procedure to be followed. Dispatch procedure Authorized officer prepares the list of products to be dispatched with full details as per shown below. Item code Description of the item Rate of excise duty to be charged while billing Batch no. Total quantity Total no. of boxes Quantity in loose boxes Retail price per unit Instruction for dispatch:
42
For the dispatch of finished products warehouse follows the RFC. RFC provides the required quantity of various products to be dispatched and emergency in percentage. The product having maximum requirement will produce first and dispatched as soon as possible and other products would be dispatched as per descending order in RFC.
Finished goods release by QA: After the goods receiving in BSR, QA will take samples from the batch. Number of samples depends upon the size of batch. Batch size Up to 2000 2000 to 50,000 Above 50,000 No. of samples 10 50 100
Until the completion of QA analysis ERP system doesn¶t allow further documentation. After the satisfactory result QA make necessary entries in the ERP system and system shows the batch ready to dispatch. Excise Invoice, Transfer Note After QA release warehouse required to prepare Excise Invoice. Because Excise Invoice is a very important document, authorized person refer the checklist given below prior to generate the Excise Invoice. Check List: Destination wise separate product list Total number of shippers and quantity in loose shippers Total quantity = no. of full box * each full box quantity + quantity in loose boxes Note down retail price After the Excise Invoice the next step is to generate Transfer Note from ERP and get it confirmed. Take printout of Excise Invoice as well as Transfer Note and get the same signed. Attach all the relevant documents wherever applicable for the dispatch and get it stamped. Security Out Pass Memo To allow the goods outside of the company premise an authorized security out pass memo has to be generate.
43
Complete the necessary entries for the clearance in daily stock account in proper folio. Before handing over the documents to driver ensure that the vehicle has been covered properly. Material out pass memo would be sent to security in-charge who should check everything in security point of view. The security in-charge should counter check the number of cartons mentioned in the material out pass memo and his deputed guard counted while loading and allow the vehicle outside the premise. The security in-charge should also make the necessary entry in the material outward register and keep the material out pass memo for future reference. Unimed has two depots: 1. Vapi (Gujarat) 2. Bhiwandi (Maharashtra) (Form-402 is required when consignment going to cross the border of state. It is applicable for Bhiwandi, not for Vapi) All the finished products are dispatches to either of these two depots. The next destination of the Product would be C & F agent. A C & F agent forwards the product to SUN Pharma.
44
7. Import
The wide portfolio of Unimed products requires large variety of raw materials from India and foreign. Company imports various raw materials on regular basis from renowned organizations of Europe, America and some other countries. Import procedure is very difficult which includes typical documentation and approval procedure from many different government authorities at the different stages of import. As import procedure became a regular practice at Unimed Company always apply for import at concessional rate of duty So general import is known here as ³import at concessional rate of duty´. Here the flow chart of the whole import procedure is produced in order to present the difficult import procedure in simple form.
IMPORT AT CONCESSIONAL RATE OF DUTY
Application for registration
Application grant
Bond acceptance procedure
Bond accepted by AC/DC
Import at concessional rate of duty
Import
Intimation for import/purchased material
45
Import of goods at concessional rate of duty for manufacture of Excisable goods:
These rules were amended in year 2002 and came into application at the first day of March 2002. Earlier these rules were made in the year 1996 and were start to applied at 1st September 1996. Import Process: 1. Registration: A manufacturer intending to avail of the benefit of an exemption shall obtain a registration from the assistant commissioner of central excise having jurisdiction over his/her factory. The registration shall contain particulars about the name and address of the manufacturer, the excisable goods produced in his factory, the nature and description of imported goods used in manufacture of such goods. Then the assistant commissioner of central excise or deputy commissioner of central excise will issue a certificate to the manufacturer indicate the particulars referred above. 2. Application by the manufacturer to obtain the benefit: A manufacturer who has obtained a certificate and intends to import any goods for use in his/her factory at concessional rate of duty, shall make an application to the assistant commissioner of central excise or deputy commissioner of central excise indicating the estimated quantity and value of such goods to be imported. Applicant shall also provide details of port of import. The manufacturer may at this option, file the application either in respect of a particular consignment or indicating his estimated requirement of such goods for a quarter. The manufacturer shall also give undertaking on the application that the imported goods shall be used for the intended purpose only. The application shall be countersigned by the assistant commissioner or deputy commissioner of central excise who shall certify there in that the manufacturer is registered in his office and has executed a bond to his satisfaction in respect of end use of imported goods in the manufacturer¶s factory and indicate the particulars of such bond. 3. Procedure to be followed by AC / DC of customs: On the basis of application countersigned by assistant commissioner or deputy commissioner of central excise, the assistant commissioner or deputy commissioner of customs at the port of import shall allow the benefit of the exemption notification to the importer. Provided that where the importer has field the application in respect of his estimated requirement for a quarter, that said assistant commissioner of customs or deputy commissioner of customs
46
shall debit in the said application, the quantity and value of import made under a particular consignment, also indicating particulars of the bill of entry, before allowing the benefit of the exemption notification to the importer. The assistant commissioner or deputy commissioner of customs will forward a bill of entry containing the particulars of import, the amount of duty paid and other relevant particulars to the assistant commissioner or deputy commissioner of central excise. 4. Procedure to be followed by AC / DC of central excise: The assistant commissioner or deputy commissioner of central excise shall acknowledge the receipt of intimation received from the assistant commissioner or deputy commissioner of customs. 5. Manufacturer to give information regarding receipt of imported goods and maintain records: The manufacturer shall give information of the receipt of imported goods in his factory, within two days (excluding holidays, if any) of such receipt, to the superintendent of central excise having jurisdiction over his factory. The manufacturer shall also maintain a simple account indicating the quantity and value of goods imported. The quantity of imported goods consumed for the intended purpose and the quantity remaining in stock, bill of entry wise. The organization has to present this account as and when required by the assistant commissioner or deputy commissioner of central excise. 6. Recovery of duty in certain case: The AC/DC of Central Excise shall insure that the goods imported are used by the manufacturer for the intended purpose and in case they are not so used take action to recover the amount equal to the difference between the duties liviable on such goods but for interest, at the rate fixed by notification issued under section 28AB of the customs act, 1962 for the period starting from the date of importation of the goods on which the exemption was availed and ending with the date of actual payment of the entire amount at he difference of duty that he is liable to pay.
47
Documents:
a. Annexure-I Broad description of the exemption notification No. 36/96-cus. b. Annexure-II It is a registration certificate. It shall be obtained from assistant commissioner or deputy commissioner of central excise. Assistant Commissioner of central excise issue the registration certificate in triplicate Annexure-II Original Duplicate Triplicate Registration holder Range superintendent AC of Central Excise
AC holds triplicate copy for reference of his office and send duplicate to superintendent so that he can register the assessee in his office as a authorized importer. c. Annexure-III It is an application form. Each time assessee want to import the raw material, he/she shall obtain the Annexure-III and fill up as per guidelines. After fill up the form he/she need to send the application to superintendent of central excise in quadruplicate copy. Superintendent verifies the application and forwards it to AC of Central Excise. Annexure-III AC of customs Range superintendent AC of central excise for office Registration certificate holder
Original Duplicate Triplicate Quadruplicate
AC endorses the necessary details and forwards the approved application to AC of customs at the port of import (an airport or sea port where imported material will arrive). I.e. factory of applicant is situated at Vadodara but imported material is to arrive at Chennai airport than AC forwards the original approved application to AC of customs at Chennai airport.
48
d. Annexure-IV It is a bond under the customs e. Annexure-V It is an intimation document shows receipt of goods at the factory premise. It should be submitted to superintendent of central excise (having authorization over his/her factory) within two days of receipt of goods at factory.
49
. EXPORT
The export contract
Introduction
Whenever any goods produced in the factory anywhere in India leaves the factory premise, it is liable to excise duty. But in order to promote the export government provide 100% exemption on duty paid by exporter. This way exporter gets relief from 1. 5% basic excise duty 2. 2% of basic duty as education cess 3. 1% secondary and higher secondary education cess Unimed exports its products in countries like, Guyana, Thailand. Mauritius, Netherlands, Algeria, Peru, Russia, South Africa etc. The first step of export is export contract. An export contract (also referred to as a sales contract) is essentially an agreement between exporter and a foreign importer to do business. The export contract can take many different forms. For example: 1. A telephonic offer to sell, covering essential issues such as the product details, quantities offered, price per unit, delivery particulars and payment terms, made by the exporter to the foreign buyer (or an offer to buy from the importer to the exporter) and confirmed by the second party is one example of a legitimate export contract. 2. Similarly, any written offer (quotation), either contained in a formal written contract and posted or couriered to the importer, or sent by e-mail, fax, telex or cable to the importer, and confirmed (usually also in writing) by the importer, is another form of legitimate contract. 3. A Proforma invoice sent by fax, e-mail, courier or post to the importer (usually on his/her request) and confirmed by the importer is another common form of export contract. The confirmation could be as simple as the importer writing "I agree to these terms and
50
conditions" on the proforma invoice and signing it or perhaps the importer may generate a separate, signed document agreeing to the proforma invoice which is then attached as reference.
The first offer is seldom accepted
It is seldom the case that the importer will accept the first offer made by the exporter and normally this first offer will be followed by a series of counter-offers sent back and forth between the exporter and the importer until each party is satisfied with the terms and conditions outlined in the final offer and agree to abide by it.
Be clear and precise
Whatever form the export contract takes, you need to be careful in formulating this document as they are drawn up between companies from countries which may have very different legal systems, regulations and attitudes to doing business. These differences may cause disputes even when trading with other fairly developed nations. The challenge is to make your export contracts as clear, precise and comprehensive as is possible.
The provisions in the contract
The basic provision of any contract for the sale of goods is that you, the seller (in this case, the exporter), will transfer ownership of the goods to your buyer (the importer) in exchange for payment (which, in international trade, made be made in a foreign currency). The export contract needs to specify the terms and conditions for doing this, and should at least describe:
y y y y y y y
Who is party to the contract The validity of the contracts The goods being sold (usually described in some detail) The purchase price of the goods and the currency in question The terms of payment Inspection of the goods if required Where the goods should be delivered
51
y y y y y y y y
At what point transfer of title to the goods takes place Any warranty and/or maintenance conditions associated with the sale Who is responsible for obtaining import or export licenses, if these are required What supporting documentation and/or certificates are required Who is responsible for paying import duties and other taxes Any contract performance security requirements, such as bank letters of guarantee What will happen if either of the parties defaults or cancels The provisions for independent mediation or arbitration to resolve disputes, and whether this would take place in South Africa or the importer's country, or elsewhere
y
The contract's completion date
The role of Incoterms
To provide a common terminology for international shipping and minimize misunderstandings over contract terms, the International Chamber of Commerce has developed a set of terms known as Incoterms. These are the basic terms used in international sales contracts, and you can learn more about them at the Incoterms 2000 Web site or in the Glossary of International Trade Terms in Appendix A.
Intellectual Property (IP)licensing contracts are particularly tricky
If the contract involves the licensing of proprietary information or technology, be very sure that it's precise about the licensee's rights. Vagueness about these rights can create serious problems and can lead to the loss of your intellectual property. If the licensee uses your technology to create other technologies, for example, this can severely undermine the value of your asset.
Contract must be signed by all contracting parties
Also - and this would seem obvious, but it's sometimes overlooked - be sure that all parties to the contract have signed it. For instance, if you're working through a representative, be sure that the actual buyer signs the contract. The representative's signature is not necessarily enough, because without the buyer's signature, there is no written evidence that the buyer owes you money. Last but certainly not least, have the contract examined by a lawyer familiar with the export market.
52
Export process:
In exercise of the powers conferred, the Central Government hereby, directs that rebate of whole of the duty paid on excisable goods (hereinafter referred to as materials¶) used in the manufacture or processing of export goods shall, on their exportation out of India, to any country . (1) Filing of declaration. - The manufacturer or processor shall file a declaration with the Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise having jurisdiction over the factory of manufacture describing the finished goods proposed to be manufactured or processed along with their rate of duty leviable and manufacturing/processing formula with particular reference to quantity or proportion in which the materials are actually used as well as the quality. The declaration shall also contain the tariff classification, rate of duty paid or payable on the materials so used, both in words and figures, in relation to the finished goods to be exported.
(2) Verification of Input±output ratio. ± The Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise shall verify the correctness of the ratio of input and output mentioned in the declaration filed before commencement of export of such goods, if necessary, by calling for samples of finished goods or by inspecting such goods in the factory of manufacture or process. If, after such verification, the Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise is also satisfied that there is no likelihood of evasion of duty, he may grant permission to the applicant for manufacture or processing and export of finished goods.
(3) Procurement of material. ± The manufacturer or processor shall obtain the materials to be utilised in the manufacture of the finished goods intended for export directly from the registered factory in which such goods are produced, accompanied by an invoice under rule 11 of the Central Excise Rules, 2002: Provided that the manufacturer or processor may procure materials from dealers registered for the purposes of the CENVAT Credit Rules, 2002 under invoices issued by such dealers.
53
(4) Removal of materials or partially processed material for processing. ± The Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise may permit a manufacturer to remove the materials as such or after the said materials have been partially processed during the course of manufacture or processing of finished goods to a place outside the factory -
(a) for the purposes of test, repairs, refining, reconditioning or carrying out any other operation necessary for the manufacture of the finished goods and return the same to his factory without payment of duty for further use in the manufacture of finished goods or remove the same without payment of duty in bond for export, provided that the waste, if any, arising in the course of such operation is also returned to the said factory of the manufacture or process; or
(b) for the purpose of manufacture of intermediate products necessary for the manufacture or processing of finished goods and return the said intermediate products to his factory for further use in the manufacture or process of finished goods without payment of duty or remove the same, without payment of duty for export, provided that the waste, if any, arising in the course of such operation is also returned to the factory of manufacturer or processor;
(c) Any waste arising from the processing of materials may be removed on payment of duty as if such waste is manufactured or processed in the factory of the manufacturer or processor.
(5) Procedure for export. - The goods shall be exported on the application in Form A.R.E. 2 specified in the Annexure to this notification and the procedures specified in Ministry of Finance (Department of Revenue) notification No. 42/2001-Central Excise (N.T.), dated the 26th June, 2001 shall be followed.
(6) Presentation of claim of rebate. ± The claim for rebate of duty paid on materials used in the manufacture or processing of goods shall be lodged only with the Assistant Commissioner of Central Excise or Deputy Commissioner of Central Excise having jurisdiction of the place approved for manufacture or processing of such export goods.
54
Documents required for rebate claim:
1. Form R: this form is a application for refund or rebate claim of excise duty 2. Original, Duplicate and Triplicate copy of ARE- 2 3. Duplicate copy of Excise Invoice 4. Self certified true copy of Shipping Bill 5. Self certified true copy of Custom attested Invoice and Packing List. 6. Self certified true copy of Airway Bill.
55
Documentation:
Introduction
The export process is made more complex by the wide variety of documents that the exporter needs to complete to ensure that the order reaches its destination quickly, safely and without problems. Documentation requirements for export shipments also vary widely according to the country of destination and the type of product being shipped. Most exporters rely on an international freight forwarder to handle the export documentation because of the multitude of documentary requirements involved in physically exporting goods and it is strongly recommended that you also make use of a freight forwarder to help you work your way through the maze of documentation.
The benefits of documentation
Documentation is a key means of conveying information from one person or company to another, and also serves as permanent proof of tasks and actions undertaken throughout the export process. If the documentation is complete, accurate, agreed upon by the parties involved and signed by each of these of the parties (or their representatives), the document will represent a legally binding document.
Function of export documentation
Export documentation may serve any or all of the following functions:
y y
An attestation of facts, such as a certificate of origin Evidence of the terms and conditions of a contract if carriage, such as in the case of an airway bill
56
y y y
Evidence of ownership or title to goods, such as in the case of a bill of lading A promissory note; that is, a promise to pay A demand for payment, as with a bill of exchange
Documents required for export:
1. Retail invoice (2 copy) 2. ARE 1(5 copy) 3. ARE 2 (6 copy) 4. COA (Certificate Of Analysis) 5. Commercial Invoice (3 or 5 copy) 6. Packing List 7. Bill of Lading 8. Shipping Bill 9. Certificate Of Origin
Documents required for transport:
1. Bill of lading 2. Airway bill 3. Freight transit note 4. Road consignment note 5. Export cargo shipping instruction
Documents required for payment:
1. Commercial Invoice 2. Letter of credit 3. Transport documents
Insurance documents:
1. Marine insurance
57
Introduction to all the documents:
1. Certification:
Introduction In exporting, it is quite common for cargos to require a variety of certificates, including certificates of origin, certificates of value, certificates of health, Consular certificates, etc. before they are permitted to be imported into the country of destination. The purpose of a certificate is to provide preshipment confirmation of the status of a particular aspect (health, value, condition, origin, etc.) of a specific cargo. Certificates of origin A Certificate of Origin (C/O) is required by some countries and is intended to certify to the importing authorities as to which country the products being imported were manufactured in that is, the C/O certifies that the imported product meets the 'Country of Origin' requirements set by the importing country and which are expected of their foreign suppliers. It may be required that the C/O include information such as local material and labour content. Certificates of Value (and Origin) A Certificate of Value is intended to confirm the value of a cargo to assist in quick clearing of the goods in the country of destination. Often the Certificate of value is combined with a Certificate of Origin and is referred to as a Certificate of Value and Origin (CVO). A CVO outlines details about the labor and packing costs, royalties or commissions (if applicable), freight charges and any overseas insurance costs. The CVO also provides an exporter's declaration and statement, in the form of clauses, about the value and origin of the goods. Fumigation certificate Some countries, such as Australia, Canada, New Zealand, the US and the UK, are very strict about letting in goods that might contain bacteria or insects that could harm their agriculture. Fumigation certificates usually contain details such as purpose of treatment, the articles in
58
question, temperature range used, chemicals and concentration used, etc. Sometimes they may be required for sea shipments, but not for air shipments. Certificates of health Certificates of health are normally required by the importing country to ensure that the imported goods (plants, plant products, animals and animal products) are in good health and carry no diseases, pests or any health-threatening organisms. Such certificates of health confirm (a) The origin of the shipment and, (b) That local authorities have inspected the consignment and ensure its good health. Certificates of Health can be divided into two types:
y
Phytosanitary certificates which are required for the import of certain plants and plant products such as seeds and flowers.
y
Veterinary certificates which are required for the import of live animals, as well as fresh, chilled or frozen animal products. For contact details go to.
Pre-shipment inspection certificates It is not uncommon for importers to want to confirm that the to-be-exported goods meet their requirements. This is particularly so in instances where it is essential that the goods meet certain standards, they may: a. Require that the shipment be inspected just before loading by an independent third-party arranged and generally paid for by the importer. b. Ask the exporter to obtain the pre-shipment inspection certificate from an independent third-party inspection firm which is then forwarded to the importer. The independent contractor - usually a recognized firm in this field - will undertake a detailed inspection of equipment or materials after manufacture, but prior to shipment. The scope of the inspection includes quantity and quality, packing and marking and supervision of loading.
59
2. The Airway bill Air waybills (AWB) are a form of BOL (Bill Of Lading) and are used for both domestic and international flights. An AWB (also referred to as air consignment note or airway bill of lading) refers to a documentary receipt issued by a carrier (i.e. airline) in favor of a shipper for goods received and is evidence of the contract of carriage to carry the goods to a specified airport under specified conditions, but it is not a document of title to the goods. It serves as:
y y y
Proof of receipt of the goods for shipment Evidence of the contract of carriage An invoice for the freight, reflecting the shipper, the consignee and the goods being shipped, as well as the full freight amount
y y y
A certificate of insurance (if carriers insurance is requested by the shipper) A guide to airline staff for the handling, dispatch and delivery of the consignment A means of clearing the goods through customs
Usually, the AWB consists of three originals and nine copies. The first original is intended for the carrier (airline) and is signed by the exporter (or agent); the second original ± the consignee's copy ± is also signed by the exporter (or agent) and accompanies the goods; the third original is signed by the carrier and is handed to the exporter (or agent) as a receipt for the goods after they have been accepted for carriage. Types of air waybills There are two types of air waybills used for the international transportation of air cargo:
y y
The "airline air waybill", with preprinted issuing carrier identification, The "neutral air waybill" without preprinted identification of the issuing carrier in any form and used by other bodies than air carriers (such as freight forwarder).forma invoice
60
3. Proforma invoice Introduction A Proforma invoice is little more than a pre advice of what will stand in the commercial invoice once negotiations have been completed. The proforma invoice serves as a negotiating instrument. The initial proforma invoice often sets the stage for the first round of negotiations if the exporter and importer have not yet had any real discussions. Role of the Proforma Invoice. Only one final proforma invoice is necessary to confirm that the two parties are indeed in agreement. Every proforma invoice should be as precise and as explicit as possible to ensure that both parties understand each other. If the importer is satisfied with this final proforma invoice, he/she will request their bank to issue an L/C on the strength of information stipulated in the proforma invoice. Details pertinent to the proforma invoice The following details are pertinent to the setting up of the proforma invoice and need careful attention:
y y y y y y
A complete and clear description of the goods in question The quantity of goods in question including the number and kinds of packaging involved The total price of the goods (and unit price where applicable) The currency in which the goods will be sold (e.g. US dollars or rands) The likely delivery schedule and delivery terms The physical addresses of both the exporter (referred to as the shipper) and importer (sometimes referred to as the consignee)
y y y
The payment methods, for example cash in advance or L/C The payment terms, for example 30 days on sight The Incoterm to be used
61
y
Who is responsible for the banking fees and other related costs (insurance and freight costs are covered by the Inco term in question)
y y y
The exporter's banking details The country of origin of the goods The expected country of final destination
4. Commercial invoice Introduction After the pro-forma invoice is accepted, the exporter must prepare a commercial invoice. The commercial invoice is required by both the exporter and importer. In exporting, the commercial invoice is considered a very important document as it serves as the starting document that underpins an export transaction. The commercial invoice is essentially a bill from the seller to the buyer describing the goods to be sold and the terms involved. The commercial invoice will normally be presented on the exporter's letterhead and will be addressed to the importer. It should contain full details of the consignment, including price and other related costs, in order to facilitate customs clearance. It must be signed and dated. What should appear in the commercial invoice? The following details need to appear in the commercial invoice: The name of the shipper/exporter and their contact details, including physical address The name of the importer/consignee and their contact details, including physical address An order number of reference to correspondence between the supplier and importer A complete and clear description of the goods in question (including brandmarks and the HS number)
y y
y y y y
The packing details unless provided in a separate packing list The quantity of goods in question including the number and kinds of packaging involved
62
y
The external dimensions, cubic capacity, weight, numbers and contents of each package shipped.
y
The total price of the goods (and unit price where applicable) usually quotes as a CIF/FOB price
y y y y y y y
The currency in which the goods will be sold (e.g. US dollars or rands) The type and amount of discount given The likely delivery schedule and delivery terms The payment methods, for example cash in advance or L/C The payment terms, for example 30 days on sight The Incoterm to be used Who is responsible for the banking fees and other related costs (insurance and freight costs are covered by the incoterm in question)
y y y y y y
What the freight and insurance charges are The exporter's banking details A declaration of the country of origin of the goods The expected country of final destination Any freight details such as the port of loading and discharge Any other information relevant to the order
5. Letter of credit In this section we discuss the following topics and terminology within the area of documentary credits: Sight credits This is an easy enough term to explain. A sight credit or L/C is one which paid upon presentation of the required documentation to the issuing or confirming bank. An exporter need to be careful however, as some L/Cs state that payment will only be made at a specified branch counter of the issuing or confirming.
63
Usance credits An L/C can specify any credit period that you have negotiated with the importer. A letter of credit that that incorporates a payment after a given term (e.g. 60 days) is known as a usance credit (also referred to as a term or acceptance credit). Transferable credits An irrevocable L/C may also be transferable. In the case of a transferable L/C, the exporter can transfer all or part of his/her rights to another party. Transferable letters of credit are often used when the exporter is the importer's agent or a middleperson (i.e. export agent) between supplier and importer, and not the actual supplier of merchandise. With a transferable letter of credit, the exporter uses the credit standing of the issuing bank and avoids having to borrow or use his own funds to buy goods from a supplier. Revolving credits The term "revolving" is used to describe a letter of credit, which, incorporates a condition whereby the credit amount is to be renewed or reinstated automatically without the need for a specific amendments to the credit. This type of credit is used when regular trade is conducted between an exporter and an overseas buyer. A revolving credit can be irrevocable or confirmed. Back-to-back credits When an exporter, who is not a manufacturer, but obtains goods from a supplier by acting as an export agent for the supplier for example, has received an L/C from an importer, the exporter, in turn, may request his bank to open a L/C in favour of his supplier on the strength of the existing L/C. These two credits are said to be "back-to-back", that is to say the one is issued on the security of the other. Standby credits A standby L/C is one which is issued in favour of the exporter for the purpose of "backing-up" certain specified obligations of the importer. A standby letter of credit requires the exporter's
64
presentation of documents which indicate that importer has not met the obligations which the standby letter of credit backs-up. 6. Packing lists: Introduction When you prepare your goods for shipment, you will be required to prepare a detailed export packing list. This is a formal document that itemizes quite a number of details about the cargo such as:
y y y y y y y y y
Name and contact details The importer's/consignee's/buyer's name, address and contact details The gross, tare and net weights of the cargo The nature, quality and specifications of the product being shipped The type of package (such as pallet, box, crate, drum, carton, etc.) The measurements/dimensions of each package The number of pallets/boxes/crates/drums, etc. The contents of each pallet or box (or other container) The package markings, if any, as well as shipper's and buyer's reference numbers
The purpose of the packing list The packing list should be attached to the outside of a package in a waterproof envelope or plastic sheath marked "Packing list enclosed". The list is used by the shipper or forwarding agent to determine (1) the total shipment weight and volume and (2) whether the correct cargo is being shipped. Be careful while preparing packing list It is important for you to realize that any mistake on the packing list may cause a delay in clearance at the port of destination. Customs Authorities in the target country have the right to delay the clearance of the shipment until the importer provides a packing list reflecting the real contents of the container.
65
7. Road consignment note: The road consignment note is :
y y y
Proof of receipt of the goods for transportation by road Evidence of the contract of carriage An invoice for the freight, reflecting the shipper, the consignee and the goods being shipped, as well as the full freight amount
y y
A guide to the road hauler for the handling, dispatch and delivery of the consignment A means of clearing the goods through customs
To clear the goods through customs, the road consignment note will need to be accompanied by a commercial invoice, a packing list and any other documentation relevant for clearing purposes.
A Freight Transit Order (FTO) is a form of inland BOL used in South Africa and required by Spoornet, the primary rail operator in the country. Transport documents and special Instructions Spoornet has the following to say about transport documents:
y
y
y
. Freight transit order:
Spoornet shall only accept goods into its care if it has been timeously furnished with fully completed transport documents, or the relevant Electronic Data Interchange information, by the consignor who warrants that all information reflected on the transport documents is accurate in all respects. The consignor shall indemnify Spoornet and hold it harmless against all losses, damages, expenses and fines arising from any inaccuracy or omission made by the Consignor in the transport documents. Wherever it is necessary, for the purpose of these conditions or any other purpose whatever, for special instructions such as stoppage or diversion of goods to be given to Spoornet, such instructions shall only be recognised by Spoornet as valid if they are timeously given and agreed to by Spoornet.
66
9.
Bill of lading (BOL or B/L):
Introduction A BOL is one of the oldest and most common forms of transportation documents in use today. It is a document that establishes the terms of a contract between a shipping company (or its agent) and the exporter/shipper (or agent, such as a freight forwarder). Within this contract, it is agreed that freight is to be moved between specified points for a specified charge. Some more detail The BOL is normally completed by the exporter on forms issued by the shipping carrier. The BOL serves as a document of title, a contract of carriage, and a receipt for goods. The BOL also describes the kind and quantity of goods being shipped (such as the number of packages, the weight and consignment dimensions), the shipper (or exporter), the consignee (the person or firm to whom the goods are being shipped), the ports of loading and discharge, and the carrying vessel. Key points of BOLs The key points that exporter should take note of, are:
y
The BOL is a legal contract between the shipper (normally the exporter) and carrier (the shipping line represented by the ship¶s master or shipping line representative)
y
As a legal document, the BOL plays an important role in releasing payment from the bank in conjunction with the Letter of Credit
y
A BOL is a document issued by a carrier, e.g. a ship's master or by the carrier¶s shipping department, or a representative of either of these two
y y y
The BOL must be signed or authenticated by the person issuing the document The BOL must name the ship/vessel carrying the goods The BOL does not afford the holder of the document any ownership of the goods listed in the document (it is not a negotiable document)
y
The BOL acknowledges that specified goods have been received on board as cargo for conveyance
67
y y y y
The BOL specifies both the ports of loading and discharge The BOL normally has a named consignee The BOL will specify the goods to be conveyed, their number, weight and volume BOLs are usually issued in three originals; one for the exporter/shipper, one for the shipping line and one for receiver/consignee of the goods.
10. ARE 1: It is annexure 14: application for removal of excisable goods for export. Original and Duplicate copies of ARE 1 are sent with dispatch. Triplicate copy goes to range superintendent. Superintendent signs the copy and forwards to custom. Quadruplicate copy retains with range superintendent for official use. Quintuplicate copy retains with consigner.
11. ARE 2:
Combined for rebate
application of duty
for paid on
removal excisable
of
goods
for used in
export the
under manufacture
claim and
materials
packing of such goods and removal of dutiable excisable goods for export under claim for rebate of finished stage Central Excise Duty or under bond without payment of finished stage Central Excise Duty leviable on export goods. Original and Duplicate copies are sent with dispatch. Both the copies are signed by customs and returned back to the consigner. Other copies would be presented as a proof of export at the time of rebate claim.
68
ATTACHMENTS
1. ARE 1
ANNEXURE-14
Range........... Division..............Address..................... Commissionerate.................... Original (White) Duplicate (Buff) Triplicate (Pink) Quadruplicate (Green)
FORM A.R.E. 1 Application for removal of excisable goods for export by (Air/Sea/Post/Land)*
To Superintendent of Central Excise ........................(Full Postal Address) 1. Particulars of [Assistant/Deputy Commissioner of Central Excise]/Maritime Commissioner of Central Excise from whom rebate shall be claimed/with whom bond/undertaking is executed and his complete postal address. 2. I/We........ Of ..............propose to export the under-mentioned consignment to ........... (Country of destination) by Air/Sea/Land/Parcel Post under claim for rebate/bond/undertaking*.
Particulars of Manufacturer of goods-and his Central Excise Registration No.
Gross No. and Description weight/Net of packages weight
Marks and Nos. on packages
Quantity of goods
Description of Goods
(1)
(2)
(3)
(4)
(5)
(6)
69
Duty Value Rate (7) (8) Amt. (Rs.) (9)
No. and date of Invoice under which duty was paid/No. Amount of Remarks and date of bond/undertaking executed under Rule 19 Rebate claimed (10) (11) (12)
3. I/We hereby certify that the above- mentioned goods have been manufactured. (a) availing facility/without availing facility of CENVAT credit under CENVAT Credit Rules, 2001 (b) availing facility/without availing facility under Notification 41/2001-CE(N.T.), dated 26th June, 2001 issued under rule 18 of Central Excise(No.2) Rules, 2001. (c) availing facility/without availing facility under Notification 43/2001-CE(N.T.), dated 26th June, 2001 issued under rule 19 of Central Excise(No.2) Rules, 2001. 4. I/We hereby declare that the export is in discharge of the export obligation under a Quantity based Advance Licence/ /Under Claim of Duty Drawback under Customs & Central Excise Duties Drawback Rules, 1995. 5. I/We hereby declare that the above particulars are true and correctly stated. Time of Removal.................................. Signature of owner or his Authorised agent with date. Name in Block Letters & Designation (SEAL)
PART A
Certification by Central Excise Office
1. Certified that duty has been paid by debit entry in the Personal Ledger Account No. .........and/or CENVAT Account Entry No............ or recorded as payable in Daily Stock Account, on the goods described overleaf. OR Certified that the owner has entered into Bond No. ............ under Rule 19 of Central Excise (No.2) Rules, 2001 with the........................«««.[F.No.___________________], duly
70
accepted by the Assistant Commissioner/Deputy Commissioner of Central Excise________ on _________(Date). 2. Certified that I have opened and examined the packages No.....«««««««««......... and found that the particulars stated and the description of goods given overleaf and the packing list (if any) are correct and that all the packages have been stuffed in the container No. ............... with Marks .................. and the same has been sealed with Central Excise Seal/One Time Seal(OTS) No. ............. 3. I have verified with the records, the exporter is only availing the export incentives, as specified in box No.6. and found it to be true. 4. Certified that I have drawn three representative samples from the consignment (wherever necessary) and have handed over, two sets thereof duly sealed to the exporter/his authorised representative. Place..................... Date ......................
Signature (Name in Block Letters) Superintendent of Central Excise Signature (Name in Block Letters) Inspector of Central Excise
PART B
CERTIFICATION BY THE CUSTOMS OFFICER
Certified that the consignment was shipped under my supervision under Shipping Bill No_______ dated _______by S.S./Flight No.________ which left on the_______ day of________ (Month)__________(year) OR Certified that the above-mentioned consignment was stuffed in Container No._____________________ belonging to Shipping Line_____________ based on the ´Let Export Orderµ given on ____________day of.________(Month)__________year) on the Shipping Bill No______ dated__________ and sealed by seal/one time lock No._______________ in my supervision and the container was handed over to the Custodian M/s_____________________ for being shipped via ___________________(Name of the Port). OR Certified that the above-mentioned consignment has been duly identified and has passed the land frontier today at_______________ in its original condition under Bill of Exports No______________ Place_____________ Date_____________.
Signature
71
(Name and designation of the Customs Officer in Block Letters)/(Seal)
PART C
EXPORT BY POST
Certified that the consignment described overleaf has been despatched by foreign post to ««««««««« on......................day of 200«««.
Place «««.. Date «««.
Signature of Post Master (Seal)
PART D
REBATE SANCTION ORDER
(On Original, Duplicate and Triplicate) Refund Order No««««««.. dated «««««««.. Rebate of Rs«««««.. (Rupees «««««««««««««««..) sanctioned vide Cheque No. ««««««dated «««««««
Place «««.. Date «««.
Assistant/Deputy Commissioner/Maritime Commissioner of Central Excise
72
2. ARE 2
ANNEXURE-23
ARE 2 No.______________ Original (White) Duplicate (Butff) Triplicate (Pink) Quadruplicate (Green) Quintuplicate (Blue)
Form A.R.E. 2 Combined application for removal of goods for export under claim for rebate of duty paid on excisable materials used in the manufacture and packing of such goods and removal of dutiable excisable goods for export under claim for rebate of finished stage Central Excise Duty or under bond without payment of finished stage Central Excise Duty leviable on export goods.
To The Superintendent of Central Excise. (Address) ___________________ (full postal address) 1. Particulars of the Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise from whom rebate shall be claimed/ with whom bond is executed and his complete postal address __________________ 2. I / We______________ of ________________ propose to export the under mentioned goods (details of which are given in Table 1 below) to_________________ (country of destination) by *air/sea/land/post parcel* under claim for rebate of duty paid on excisable materials used in the manufacture and packing of such goods. 3. *The finished goods being exported are not dutiable or We intended to claim the rebate of Central Excise Duty paid on clearances of goods for export under notification 40/2001-CE(N.T.), dated 26th June, 2001 issued under Rule 18 of Central Excise (No.2) Rules, 2001.
or The Export goods are intended to be cleared without payment of Central Excise Duty under notification 42/2001-CE(N.T.), dated 26th June, 2001 issued under Rule 19 of Central Excise (No.2) Rules, 2001.
73
TABLE - 1 (Details of goods to be exported)
Net Weight Descri Marks Sl. Gross and ption of &Nos. on No. Weight quantity packages packages of goods** (1) (2) (3) (4) (5)
Finished Stage Central DescriInvoice Excise Duty ption of Value No. & finished date goods Rate Amount (6) (7) (8) (9) (10)
Bond/ Undertaking executed under rule 19(if any) (11)
Amount of Rebate Remarks Claimed under Rule 18 (12) (13)
*Strike out portion not applicable **Quantity of goods to be furnished in units of sale where it is different than weight. #Write NA where exports are under bond/letter of undertaking in terms of Rule 19 or where goods are not chargeable to duty
TABLE 2
Details of duty paid excisable Materials and Packing materials used in manufacture of export goods for which rebate under notification _________ dated_________is being claimed
Name/ description of Central Name Sl. materials/packing Excise Unit Qty.used of No. with technical Tariff Supplier specification/ Subheading Quantity (1) (2) (3) (4) (5) (6)
Total Wastages Duty Invoice Rate of Assessable Amt. No. & Central Value/Unit per ReIrreValue/Unit Excise Rs. unit coverable coverable Rs. duty Rs. (7) (8) (9) (10) (11) (12)
Reb adm und Rule Rs.
(13)
Declaration : a. We hereby certify that we have not availed facility of CENVAT credit under CENVAT Credit Rules, 2001
74
b. We hereby declare that the export is not in discharge of export obligation under a Value based Advance Licence issued prior to 31.03.95 c. We hereby declare that the materials on which input stage rebate in claimed are not sought to be imported under a Quantity Based Advance Licence issued prior to 31.03.95. d. We further declare that we shall not claim any Drawback on export of the consignment covered under this application. e. I / We hereby declare that the above particulars are true and correctly stated. f. We have been granted permission by Assistant Commissioner of Central Excise or Deputy Commissioner of Central Excise vide
C.No.__________ date __________ for working under Notification ____________ dated ______ .
Time of Removal __________________
Signature of owner or his authorised agent with date Name in Block Letters & Designation SEAL Note 1: The A.R.E. 2 should be submitted by the manufacturer at least 24 hours intended removal of goods for export, to the superintendent of Central Excise. Note 2: A running serial of the factory starting with one every financial year should be allotted to every A.R.E. 2
FOR DEPARTMENT USE PART A CERTIFICATION BY THE CENTRAL EXCISE OFFICER
1. Certified that *duty has been paid on the goods described above or duty is payable as recoded at entry number___ in Daily Stock Account. or *the owner has entered into B-1 bond No ____________ /given an Undertaking ______under Rule 19 of Central Excise (No.2) Rules, 2001 with the_______________________ or *the finished goods being exported are not dutiable 2. Certified that I have opened and examined the packages No. ___________________ and found that the particulars stated and the description of goods given overleaf read with the invoice and the packing list (if any) correct *[and that all the packages have been stuffed in the container No._______________ with Marks ________________]*and the same has been sealed with Central Excise Seal/*One Time Seal (OST) No.__________ 3. I have verified with the records, the declaration of the manufacture given at Sl. No. 3 overleaf regarding non availment of credit under rule CENVAT Rules and found it to be true.
75
4. Certified that I have drawn three representative samples from the consignment and have handed over two sets thereof thereof duty sealed to the manufacturer/ his authorised representative. (wherever feasible) 5. Certified that the material consumption's indicated in Table 2 overleaf are in accordance with the declaration No. _____________filed by__________on___________ Place : __________________ Date : __________________ Signature (Name in Block Letters) Superintendent of Central Excise Signature (Name in Block Letters) Inspector of Central Excise *Strike out inapplicable portions Note 3 : The details given in table 2 may be verified by the Superintendent of Central Excise subsequent to clearances. For this purpose a detailed verification report may be submitted by the Superintendent to the Assistant Commissioner of Central Excise along with Triplicate copy of A.R.E. 2 Note 4 : The original -duplicate and sixtuplicate shall be returned to the manufacturer for presenting to the Customs Officer.
PART B Certification by the Customs Officer
1. Certified that I have examined the consignment described overleaf, and the seals on the packages were found intact and I have satisfied myself that particulars of the consignment are as specified overleaf except for the shortages mentioned below:
2. Certified that the exports are not under Duty Drawback Scheme. It is further certified that exports are not in discharge of export obligation under Value Based Advance Licence or a Quantity Based Advance Licence issued before 31.03.95. 3. Certified that all copies of Shipping Bill / Bill of export contain endorsement of A.R.E. 2 No. in the space provided for indicating ARE 1. 4. Certified that the consignment was shipped under my supervision under *Shipping Bill No. / Bill of Export No. ____________ _____________dated___________ which left for _____________ on __________/ which passed the frontier on ____________ 5. Duplicate copy of A.R.E. 2 Forwarded to Assistant/Deputy Commissioner of Central Excise .................. on ..................... Place Date
76
Signature (Name and designation of the Customs Officer in Block letters) (Seal)
Note 5 : The customs shall send the duplicate to the address given at Sl. No. 1 over leaf and handover original and sixtuplicate to the exporter.
PART C* Rebate Sanction Order Under Rule 18(1) (On Original, Duplicate and Triplicate)
Refund Order No. ______________ dated ______________ Rebate of Rs. ___________ (Rupees _____________ sanctioned vide cheque No.___________ dated ____________ Place ______________ Date ______________ Assistant/Deputy Commissioner of Central Excise
PART D Rebate Sanction Order under rule 18(2) (On Original, Duplicate and Triplicate)
Refund Order No. _______________ dated ______________________ Rebate of Rs. ____________________ (Rupees ________________________________ sanctioned vide cheque No._________________ dated____________ Place __________________ Date _______________ Assistant/Deputy Commissioner of Central Excise
77
3. Commercial Invoice
1. EXPORTER 2. CONSIGNEE 3. INTERMEDIATE CONSIGNEE - The name and address of the party who effects delivery of the merchandise to the ultimate consignee, or the party so named on the Export License. 4. FORWARDING AGENT 5. COMMERCIAL INVOICE NO.
78
6. CUSTOMER PURCHASE ORDER NO. 7. B/L, AWB NO. 8. COUNTRY OF ORIGIN 9. DATE OF EXPORT 10. TERMS OF PAYMENT 11. EXPORT REFERENCES 12. AIR/OCEAN PORT OF EMBARKATION 13. EXPORTING CARRIER/ROUTE 14. PACKAGES - Record number of packages, cartons, or containers per description line. 15. QUANTITY - Record total number of units per description line. 16. NET WEIGHT/GROSS WEIGHT - Record total net weight and total gross weight 17. DESCRIPTION OF MERCHANDISE 18. UNIT PRICE/TOTAL VALUE 19. PACKAGE MARKS 20. MISC. CHARGES 21. CERTIFICATIONS
79
4. Proforma invoice
80
5. Packing list
81
doc_152179589.docx
this report is my summer internship report on the subject dispatch and import - export. apart from all the details about import and export this report is also consist an overview of all the departments of the company and their functions
Dispatch & Import Export
-A summer internship report (June-July 2011)
Guided By: Mr. Jigneshkumar Soni Prepared By: Nikul G Moradiya (10066) Master of Business Administration 2010 12
Submitted To: Unimed Technologies Limited
G H Patel Post Graduate Institute of Business Management 9/7/2011
I.
PREFACE
Pharmaceutical industry is one of the highest growing industries in India and this report presents a live picture of one such leading organization in the same industry: Unimed Technology Limited. This report is divided in two parts. Part:-1 It introduces all the departments of the organization and their functions.
Basically it is just an overview with enough details so that any person, reading this report might fill him/herself acquainted of the pharma industry. There are many jargons and technical details used in this report because to know about the pharma company, any person (either science or non science background) must go through at least this much of details. Part:-2 this part presents the core subject of my summer internship. Here the complete
process and all possible details of IMPORT ± EXPORT and DISPATCH are given. Reader may find a bit typical law language in this part. I have tried my best to translate this language in simple form without omitting important details and modification of meanings. Almost all the laws and change in rules related to import ± export has been covered. Documentation is the most important part of import ± export process. This report covers detailed information about the all required documents and possible samples of documents are also attached.
2
II.
ACKNOWLEDGEMENT
I have taken efforts in this project. However, it would not have been possible without the kind support and help of many individuals of Unimed Technologies Limited. I would like to extend my sincere thanks to all of them. I am highly indebted to Mr. JIGNESHKUMAR SONI, Head; BSR/UTL for their guidance and constant supervision as well as for providing necessary information regarding the project & also for their support in completing the project. I would like to express my gratitude towards Mr. Pushpendrakumar Jain Mr. Ajit Thakor Mr. Jagat unadkat Mr. Bhagvan Nehate Mr. Rameshchandra Joshi Mr. Ashim Tendulkar Mr. Nilesh Bhatt Mr. Vijay Kashyap Mr. Sameer Shah General Manager, Operations Head, Personnel and Administration Assistant manager, production Head, production Assistant manager, engineering Head, Engineering Head, Quality Assurance Head, Quality Control Assistant manager, Store
For their kind co-operation and encouragement which help me in completion of this project. I would like to express my gratitude and thanks to all of them for giving me such attention and time.
3
INDEX
Page No.
Preface Acknowledgement Part I An overview of Indian pharma industry Personnel & Administration department Engineering department Production department Packaging department Quality Assurance & Quality Control department Part II Warehouse department Dispatch Import Export Attachments
2 3 5 9 14 20 27 29 36 41 45 50 69
4
An Overview of Indian Pharma industry
The Indian Pharmaceutical Industry today is in the front rank of India¶s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. Playing a key role in promoting and sustaining development in the vital field of medicines, Indian Pharma Industry boasts of quality producers with many units approved by regulatory authorities in USA and UK.
Domestic Market: US $ 7bn
Export: US $ 5bn
Total: US $ 12-13bn
Contract manufacturing -JV/Alliance -competition from China
Domestic formulation -IPR regime -pricing pressure on old molecules -brands differianted products
Generic business
Indian pharma
-Increasing competition -Prising pressure -Acquisition -aggressive build up of products
-ANDA/NDDS/NEC -Out Licensing -High Investment / Long Gestation
5
Indian pharma sector: Growth Scenario in 2010 Third in the world in terms of volume. Rank is 14th in terms of value. The domestic market was worth US$ 12.26 billion. Market reached US$ 10.04 billion in size in July 2010. The Indian Pharma Industry is estimated to be worth $ 4.5 billion Growing at about 8 to 9 percent annually.
KEY OPPORTUNITY SEGMENTS
Manufacturing opportunities
Manufacturing opportunities
Indian pharmaceutical industry
Innovation opportunities
Contract research
Leading Pharmaceutical Companies
6
In the domestic market, Cipla retained its leadership position with 5.27 per cent share. Ranbaxy followed next. The highest growth was for Mankind Pharma (37.2%). Other leading companies in the Indian pharma market in 2010 are
y y y y y y y y
Sun Pharma (25.7%) Abbott (25%) Zydus Cadila (24.1%) Alkem Laboratories (23.3%) Pfizer (23.6 %) GSK India (19%) Piramal Healthcare (18.6 %) Lupin (18.8 %) The Indian pharmaceuticals market is expected to reach US$ 55 billion in 2020 from US$ 12.6 billion in 2009. This was stated in a report title "India Pharma 2020: Propelling access and acceptance, realising true potential" by McKinsey & Company. In the same report, it was also mentioned that in an aggressive growth scenario, the pharma market has the further potential to reach US$ 70 billion by 2020
Due to increase in the population of high income group, there is every likelihood that they will open a potential US$ 8 billion market for multinational companies selling costly drugs by 2015. This was estimated in a report by Ernst & Young. The domestic pharma market is estimated to touch US$ 20 billion by 2015. The healthcare market in India to reach US$ 31.59 billion by 2020. The sale of all types of pharmaceutical drugs and medicines in the country stands at US$ 9.61 billion, which is expected to reach around US$ 19.22 billion by 2012. Thus India would really become a lucrative destination for clinical trials for global giants.
7
Unimed Technologies Limited
Unimed has been established in the year 1990. Company¶s production plant is situated above 36 Km east from VADODARA & 6 km away from HALOL. Unimed is one of the leading companies, having an asset of its quality products. Unimed works under loan license of SUN pharma. Unimed is producing Parenteral, Ophthalmic and Hormone products. Currently company is producing more than 100 products. Few well known Unimed products are Cardiject injection Careprost Depopred Eyemist Fertigyn Ivepred Letoprost Lupride depot Ocepred, etc. Unimed is also preparing to launch its new plant for production of ANDA ³Abbreviated New Drug Application´. This plant is constructed according to US FDA guidelines. UTL has also constructed a gas based power plant to become self-reliable.
8
Part - I
1. Personnel & administration
The meaning of HR is Human Resource but at the Unimed it¶s also stands for Happy Relations. The human resource department of the company deals with employment, recruitment and placement. It also takes care of employer-employee relations, compensation benefits and training & development. The role of HR is not only managing the human resource but also it is a strategic business contributor. It is not worthless to say that HR provides the support to management in accomplishing the original objectives. Intellectual management or human resource management in this transition phase is handling by HR.
ORGANOGRAM OF UNIMED TECHNOLOGIES LIMITEDLIMITED
9
HOD of each department is supported by cluster of subordinates and we can present them in form of hierarchical chart as per below«..
This kind of organized structure of manpower always produces the desired results and pushing forwards the organization towards the achievement of objectives.
10
1.1.
Recruitment process
There are ten ways for not to do the work, but there is only one way to do the work. Probably this saying is worth for any employee in any organization. The recruitment and selection is the major function of the human resource department and recruitment process is the first step towards creating the competitive strength and the strategic advantage for the organizations. Recruitment process involves a systematic procedure from sourcing the candidate to arranging and conducting the interviews and requires many resources and time. At the Unimed recruitment process is conducted by the very experienced team of HR specialists and professionals from other departments. The whole process can be described in few simple steps.
11
Identify vacancy
Jo b description and job specification
Search resume relevant to job Scrutinization of resume Arrange interviews Conduct interviews Final selection Appointment process
1.2. Training process a. Induction b. General QA system training c. Departmental SOP training d. On Job Training e. GMP f. Evaluation g. Qualification and approval
12
1.3.
Appraisal
People differ in their abilities and their aptitudes. There is always some difference between the quality and quantity of the same work on the same job being done by two different people. Performance appraisals of Employees are necessary to understand each employee¶s abilities, competencies and relative merit and worth for the organization. Performance appraisal rates the employees in terms of their performance.
Performance appraisals are widely used in the society. An employer evaluating their employees is a very old concept. Performance appraisals are an indispensable part of performance measurement.
The latest mantra being followed by organizations across the world being "get paid according to what you contribute" the focus of the organizations is turning to performance management and specifically
to individual performance. Performance appraisal helps to rate the performance of the employees and evaluate their contribution towards the organizational goals.
Performance appraisal takes into account the past performance of the employees and focuses on the improvement of the future performance of the employees.
1.4.
Motivation
En employee can be compared with the milking cow. If they would be taken care of (economically and emotionally) then they will produce the best outcome. At the Unimed employees are being awarded regular increments as well as promotions to superior designation as per their work experience and commitment towards the organization. Apart from money factor, employees are regularly undergoes to medical checkup which shows commitment of organization towards the employees. Employees are also having enough sick leaves, paid leaves and casual leaves which transforms into a unique working experience without disturbing social life of individual.
13
2. Engineering
RO PW
WFI
Generator GEB supply
14
2.1.
Water supply
The natural water contains solid, liquid and gaseous impurities and therefore, this water cannot be used in process. The impurities present in the water cannot be removed before its use. The necessity for reducing the corrosive nature & quantity of dissolved and suspended solid s in the feed water has become increasingly important with advent of utilities or process application.
2.1.1. Impurities in water:
The impurities present in the feed water are classified as given below,
Impurities in water
Un-dissolved and suspended solid materials. Turbidity & sediments Sodium and potassium salts Chloride Iron Manganese Silica Microbiological growth Color
Dissolved salts and minerals
Other minerals
Dissolved gases
calcium salt magnesium salt
free mineral acid oil
CO2 O2
2.1.2. Reverse osmosis process
The reverse osmosis system is composed of two major parts: the high pressure pump and the membranes. The initial purified water production rate is measured at this pressure. It appears that there are longer-term benefits to be gained by operating at lower percent water recovery, particularly in reducing maintenance to the systems, and maintaining precipitation problems,
15
which may arise due to operator error. It is important to realize that the purified water from a reverse osmosis system is delivered essentially at atmospheric pressure, usually to a vented storage tank. In general, it cannot be operated by opening and closing a valve in the product water lines (unless special pressure relief is provided). The reason for this is that the high pressure in the system drives the water across the membrane, and no flow of water would be possible if the pressure on both sides of the membrane were the same. If for some reason, the product water line was closed while the system was operating. The pressure would build up. Of course, if the purified waterside off the system were strong enough, the problems, which may arise due to operator error, would be minimized.
2.1.3. Process chart
Utility area
16
2.2.
Air System
Air supplied by the engineering unit is of two types: HVLP (High Volume Low Pressure) air & LVHP (Low Volume High Pressure) air. HVLP is maintained through Air handling Unit (AHU) and LVHP is used as compressed dry air.
Air Handling Unit
AHU is a device used to condition and circulate air as part of a heating, ventilating, and airconditioning system. It is usually a large metal box containing a blower, heating or cooling elements filter racks or chambers, sound attenuators, and dampers. Air handlers usually connect to ductwork that distributes the conditioned air through the building and returns it to the AHU. Sometimes AHU discharge (supply) and admit (return) air directly to and from the space served without ductwork. The air handling unit affects to the temperature and humidity inside the building. In this case the control is based on several principles. The supply air temperature is kept constant to allow the adjustment of temperature in each room with separate thermostats or dampers. The supply air humidity must not exceed a certain level. Also the circulation of air should always be sufficient.
AHU components
Blower/ fan Heating and/or cooling elements Filters Humidifier Mixing chamber Heat Recovery Device Controls Vibration isolators
17
High efficiency particulate Air (HEPA)
HEPA filters are composed of a mat of randomly arranged fibers. The fibers are typically composed of fiberglass and possess diameters between 0.5 and 2.0 micrometer. Key factors affecting function are fiber diameter, filter thickness, and face velocity. The air space between HEPA filter fibers is much greater than 0.3 m. The common assumption that a HEPA filter acts like a sieve where particles smaller than the largest opening can pass through is incorrect. Unlike membrane filters, where particles as wide as the largest opening or distance between fibers cannot pass in between them at all, HEPA filters are designed to target much smaller pollutants and particles. The particles are trapped (they stick to a fiber) through a combination of the following three mechanisms: 1. Interception, where particles following a line of flow in the air stream come within one radius of a fiber and adhere to it. 2. Impaction, where larger particles are unable to avoid fibers by following the curving outlines of the air stream and are forced to embed in one of them directly; this effect increases with diminishing fiber separation and higher air flow velocity. 3. Diffusion, an enhancing mechanism is a result of the collision with gas molecules by the smallest particles, especially those below 0.1 µm in diameter, which are thereby impeded and delayed in their path through the filter. HEPA filter remove at least 99.97% of airborne particles 0.3 micrometers (µm) in diameter.
18
Nitrogen plant
1. It is used in pre & post filling of parenteral products. 2. Also used in pre & post integrity test of filter.
Ai r (78% N2 + 21% O2 + 1% other gases BLOWER Pass through CMC material, absorb O2
Nitrogen gas (NMT 0.5% O2)
ETP (Effluent Treatment Plant)
All hazardous waste will be processed at Nandesari common disposal plant and then release waste by converting in non-hazardous
Water of plant sewage Add alum, 2 layers will be separate out
Upper layer will be re-used Lower layer would be rejected
19
3.
PRODUCTION
Production is a functional area responsible for turning inputs into finished outputs through a series of production processes. The production manager is responsible for making sure that raw materials are provided and made into finished goods effectively.
Chemist room
It is an area where all workers, machine operators and officers meet daily at the starting time of their respective shift to plan complete schedule and allocate work activities. In the room one white board displays 1 month projected manufacturing schedule of production department in following format. Sr, no. Mfg. date Filling date 1 15/05/2010 16/05/2010 Product name Lotepred LS 2 16/05/2010 16/05/2010 Tropicamet HKMJ0513 100 literr Export HKMJ0522 200 liter Domestic Batch no. Batch size Remarks
Label of Batch in Process BATCH IN PROCESS DATE:__/__/201 PRODUCT NAME BATCH NUMBER BATCH SIZE MANFAACTURING SIZE EXPIRY DATE STAGE CHECKED BY
20
3.1.
SOP (Standard Operating Procedure)
It is a document which prescribes an ideal procedure for each & every activity of company. It strictly follows GMP (Good Manufacturing Practice)
Content of SOP:
Sr. no. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Title Title CC No. Supersedes Effective date Purpose Scope Reference Attachment Annexure Distribution Definition of terms Procedure History Stamp Description It is expressive of subject of SOP Change control number Mention previous SOP number Date on which SOP become effective Mention intended use of SOP Application of SOP Detail of any reference used Desired supportive documents attach with SOP Documents serve as informative guidance Area in which copy will be send to department Define in Lehman language, easy for understanding Systematic procedure as per GMP Any previous incident or abnormalities In represent green colored stamp and copy number
As per the suggestions of WHO (World Health Organization) Unimed also translate all SOP¶s in vernacular language (Gujarati) for easy understanding of workers and operators.
3.2.
BMR (Batch Manufacturing Record)
It is a file which contains all the details of batch starting from raw material receiving to finish good dispatch. BMR preserved for 1 year more than expiry date of batch
21
Content of BMR
Sr. no. 1 2 3 4 5 6 7 8 9 10 11 12 Title Product name Generic name Strength BMR status Effective date Supersedes CC no. Batch size Material pick up list Master formula Signature log Verification sheet Sr. no. Title 13 14 15 16 17 18 19 20 21 22 23 Washing of PPM Mfg process detail Filtration detail Filling detail Sterilization detail Calculation Accountability % Yield % Visual inspection record History date Cycle time
3.3.
Introduction to areas of production department
a. De cartooning area
Here primary packing materials like ampoules and vials are received. Workers arrange ampoules or vials into perforated plate which are directly sent to washing area through hedge. There would be normal pressure and room temperature would be maintained.
b. Ampoules / Vials washing area
In this area ampoules and vials are being washes in two step process 1. Inner wash: by help of purify water, water for injection and compressed air one by one. 2. Outer wash: by help of purify water & water for injection one by one. Temperature of washing area should NMT 27o C & pressure NLT 0.4 mm of WC. (WC = water column)
22
c. Equipment washing area
Here parts of equipment or tanks has to be cleaned with help of purify water and then water for injection. Temperature of washing area should NMT 27o C & pressure NLT 0.4 mm of WC (= water column)
d. Dress washing area
Equipment has capacity to process 30 pairs of dress at once. Normal room temperature and humidity would be maintained here. e. Autoclave & DHS (Dry Heat Sterilization) area Material or equipments used for preparation of parenteral products must pass through autoclave or DHS, for sterilization. This process leads to denaturation of protein of bacteria, results in death of bacterias. Autoclave wiil lead to coagulation of protein of bacteria. It has temperature NMT 27o C & humidity NMT 55%. Temperature will be automatically recorded and printed at regular interval of 3 minutes.
f. Manufacturing area
Here active ingredients & excipient of final product have been mixed according to procedure of BMR. Manufacturing area has to send in process sample of 30 ml for approval of QC department. In this area temperature, humidity, pH order of mixing and other parameters has to be followed strictly.
g. Filtration area
Bulk solution or suspension is filtered through membrane or cartilage filter by help of nitrogen gas with pressure of 0 to 2 Kg/cm2.
23
Efficiency of filter is calibrated by bubble point test.
h. Filling and capping area
In filling area product is filled in respective containers. There are 3 different types of filling tube stainless steel, glass & silicon. Initial 5 vials or ampoules have been discarded in following cases: Initial machine startup Completion of maintenance work Replacement of syringe & needle Shift change Tube filling machine- Unimed has only one product ³Eye mist Gel´ in tube form. It has 1 head. Output rate is 30 tubes / min.
i.
Visual inspection area
In this area every ampoules or vials have been checked by trained workers manually. Workers are given target based work. Each worker has to submit eye report from government hospital. Company takes on test for 100 ampoules, in which qualifying criteria is 97% accuracy. Visual department also maintain several records. i.e. temperature measurement record, sequential log sheet, daily visual inspection record, etc.
j. Freeze dry area
It works on principle of ³Lyophilization & Sublimitation´. This process has capacity to remove moisture from product by converting moisture in ice and then directly convert to vapor by passing liquid stage. Lupride Depot is freeze dried product and it Unimed is only manufacturer of this product in India.
24
k. Quarantine area
After completion of visual inspection, products are placed in this area. from this area, packing department will receive products for labeling & secondary packing with help of ³Batch transfer note´ There are different color codes for different stages of products. Purpose of color code is to identify product at each & every stage and to avoid a mix up of materials. Sr. no. 1 2 3 4 5 Color code Yellow Pink Orange Blue Red Stage of product Ready for packing Ready for visual Ready for leak test Ready for sterilization Ready for rejection
Format of label: UNDER PROCESS APPROVAL DRUG NAME STAGE BATCH CODE MFG DATE CONTAINER NO. BARCODE HKNJ0555 05/2010 VISCOMET INJ 5 ML READY FOR VISUAL INSPECTION BATCH SIZE EXP DATE 1 OUT OF 50 100 LT 04/2012
25
3.4.
SR. NO 1 2 3 4 5 6 7 8 9 10
Capacity of equipments
EQUIPMENT Autoclave DHS 2592 lit. 972 lit. 1800 lit. 2500 lit. 7000 units / hr. Ampoule filling machine Bottle filling machine Lyophilizer Vial filling line Pre filled syringe machine Tube filling machine 80 units / min. 200kg. ice condensation 6000 units / hr 4000 units / hr 6000 units / hr 60 units / hr CAPACITY
26
Packaging department
There are 6 different types of packing line in the packing department 1. Plastic bottle packing line 2. Vial packing line 3. Ampoules packing line 4. Multipack show box over wrapping packing line 5. Single pack show box over wrapping packing line Layout of packing department quarantine:
READY FOR PACKING
PART BATCH
PACKED BATCH
COOLER NO. 1 COOLER NO. 1
ENTRY & EXIT
SHREDDER MACHINE
BPR (Batch Packing Record): It is a file which contains all details of packing materials like batch number, type of label, show box, ply box, corrugated box, etc.
27
Content of BPR: Sr. no 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Title Product name Generic name Strength (content of API) BPR status(tentative, final or scale up) Effective date Supersedes CC No. Batch size Signature log Bill of material Verification sheet Calculation sheet History date Cycle time
28
4. Quality Assurance Quality Control
Introduction
Quality department ensures that quality is built in the product through implementation of quality assurance system & procedures. Quality department is responsible for ensuring safety, identity, strength, purity and quality of each product manufactured at UTL.
Quality Assurance
Below mentioned activities comes under the responsibility of quality assurance department Ensuring in process control Raw material and packing material control Batch record review Finished product approval Release finished product for sale/export Process validation Equipment qualification Cleaning validation Change control programme Event and incident investigation procedure Document control Self inspection
29
Training Handling of market complaint Vendor evaluation Factory hygiene
Quality control
Testing and compliance of the raw material & packing/packaging material to approved specifications. Compliance of in-process & validation samples to approved specifications. Compliance of finished product to approved specifications.
QC insures quality system like
Stability study Analytical method validation Microbial purity control
Quality objectives To insure strict adherence to SOPs (standard operating procedure) and cGMP in conformity with WHO, various national and international standard To audit the system against actual practices To insure defined quality procedure To train all department supervisors for good documentation practices.
30
Activity flow chart
Receipt of raw and packing material
Sampling
Analysis
Approval of material
Rejection of material
BMR/BPR Issuance
Transferred to rejection area
Dispensing of raw material
Return to vendor
Disposal of material
Manufacturing
In process checks
In process sampling
QC analysis
Reprocessing
Intermediate stage release
BMR review by QA
Bulk preliminary approval by QA
31
Finished product sampling
Packing in process check Control sample/ stability sample withdrawal QC release Final release by QA Batch rejection
Review of batch record by QA
Transferred to BSR Batch destruction
32
Quality system
Document Mfg. and control
Validation
Qualification matrix
Training
Monitoring system
Audit program
Change control
Planned modification
Event investigation
Market complain
Product recall
Risk management
Annual product review
Out of specification
Vendor qualification
Quality management review
33
Validation
Process
Cleaning
Analytical method
Computer system
Protocol preparation
Protocol review
Protocol approval
Execution work
Report
Evaluation
Not satisfactory
Satisfactory
Change
Approval
Revalidation
34
Part II
Dispatch and Import - Export
35
5. WAREHOUSE
All the activities in the warehouse can be shown in the form of a diagram given below.
Receipt of raw materials and packing materials
Storage
Dispensing of raw materials
Issuance of packing material and raw material
Receipt of finished goods in BSR
Packing of cold chain products with coolant bags
Dispatch of finished goods
36
RECEIPT AND HANDLING OF RAW MATERIAL On receiving intimation from gate by security in-charge regarding any receipt of raw material, the following matters/details are required to be verified on the basis of supplier¶s bill challan. Then supplier¶s bill/challan would be checked, whether the material is for our location, if yes then material would be allowed inward. Security will take entry in inward register and allow vehicle inside the factory. The security incharge will put the reference of the inward entry on the backside of the supplier¶s bill/challan/LR (lorry receipt) STORAGE OF RAW MATERIAL Checks and precautions Storage all the liquid raw materials on the lower most rack. Store the heavy containers at lower level of rack. All the raw materials are to be stacked in proper rows, so that movement of the materials at the time of issuance is easy. Quarantine area Store QUARANTINE materials in this area which are identified by yellow colored border dedicated area/covered with nylon net/yellow rope (if applicable) with ³Quarantine´ coupon. Try to store single consignment on one pallet, if consignment is large, use required number of pallets ensuring proper segregation. Use separators in between for stacking different material on single pallet. Approved area Store all approved materials in this area, which are identified by green colored ³Approved´ label. Rejected area Store all rejected materials in this area which are identified by red colored ³Rejected´ label Storage area Store all the raw materials in the area with respect to their storage conditions as per the list given by QC. The various storage area available are Temperature range Less than 2o C Less than 25o C Room temperature Storage area Cold storage/refrigerator/cooling cabinet A.C. store room Respective location/ store room
37
Depending on the status of materials like Quarantine/approved/rejected transfer the material to its respective location. Whenever any non compliance is observed at any stage, inform the QC department for defacing the approved label and affix the HOLD label if required. In such cases where the non-compliance is observed for limited packs / containers instead of whole lot, the same should be transferred to Quarantine area after affixing HOLD label. Necessary entries should be updated in ERP for the same. After shifting the raw material to their respective location, update the locator code in the ERP system and thereafter also whenever material is shifting from one location to another or one rack to another, update the ERP system likewise. Whenever any material (in-out) from (2o to 8o) refrigerator and (-14oC to -25oC) deep freezer like for dispensing or sampling or any reason to be note down the entry in log book register.
ISSUANCE OF PACKING MATERIALS & RAW MATERIALS Material pick up list is submitted by user department for which work order is released for issue of packing material. Procedure for issuance of packing material Do not open sterile material outside of sterile area. All packing materials which are to be issued against MIO must contain approved labels Issue material and affix packing material issue coupon. Arrange issued material on clean pallets. Counter check with material issue order. Scan barcode before issuance of primary and secondary material. Confirm MIO, print MIO Deliver issue material with confirm MIO. Ensure that all packing material are identified by properly affixing issue coupon dully filled and signed and one set to be attached with confirmed MIO for user department. Guidelines Count all material like aluminum scales, non RFS rubber stopper by multiplying the qty. mentioned by supplier for each packets and for loose quantity count the same on the basis of average weights. Sterile plastic bottles, plugs and RFS rubber stopper is to issue as per material issue order. Issue intact packets in round of qty.
38
Count all material by multiplying the qty. mentioned by supplier for each packets and for loose quantity by physical counting of each item. For issuance of labels, intact role of label issue as mentioned supplier¶s label quantity and count all loose label on label counting machine.
DISPENSING OF RAW MATERIALS Store department will receive material pickup list along with BMR from the production department. System generates material pickup list on first expire first out basis. If ERP system is not working than production will give manually request with authorization along with BMR. Access articles option in the MIO for the number of RM coupons required in ERP system. Material issue coupons will be printed out as per requirement. Raw material will be picked up according to material pickup list. Ensure that all materials having ³approved´ labels. Materials of one product will be collected at a time and arranges properly in staging room. Collect the partially dispensed containers (loose) first, for dispense and keep the material on the pallet. Reverse laminar airflow shall be switched on before half an hour before starting dispensing and pressure has to be within the limit. RLAF and dispensing room shall be clean. Balances should be calibrated before use. Temperature not more than 30oC and humidity not more than 65% (or as specified in BMR) [Process: Material from staging room will be bought to dispensing room one by one for weighing. Gross weight of raw material will be checked before starting of each dispensing and record the same in raw material bin card. Scan the bar code. Wear clean and protective apparels. Change plastic gloves after dispensing each material.]
39
Other responsibilities
1. Handling of return material from production Material can be returned in following conditions y Dispensed material but manufacturing planning changed and returned to warehouse. y In case material is returned as online rejection due to not meet the requirements. y In case of excess packing material return. All return material store as per defined storage condition & locator code defined in material return coupons. Confirm the material return memo, print, sign & give to user department. 2. Handling of rejected materials. 3. Handling of spilled materials. y In case of spillage inform the QA. y In case of liquid spillage material would be handled as per MSDS (Material Safety Data Sheet) y In case of solid material, workers will collect the material in poly bag, affix the label of spillage and send it to ETP (Effluent Treatment Plant) for disposal. y In case of organic material spillage approved absorbent will be used for absorbing. y Spillage report will be prepared and authorized by quality head, department head and plant head. 4. Handling of damaged goods. y First of all intimate the quality assurance for spot observation through ³intimation fir damaged consignment/containers.´ y During the QA examination if material will be rejected then it would be treated as mentioned earlier. y Rejected material must contain label of ³rejected in spot observation´ y If the consignment/containers are to be rejected, return it back to the supplier. y If QA recommend to redress the material then redress it in dispensing area under QA supervision. y Redress the material in suitable container and record the data. Affix the redressing label on container with having all the details of original container. If possible than retain the original label. The dully filled redressing form signed by warehouse and QA officer shall be attached with goods inward memo. y A GIM will be prepared with the remark of spot observation and would be sent to QA department.
40
6. Dispatch
At the Unimed a standard procedure for dispatching is being followed strictly. This procedure ensures the quick dispatch of finished products into the market within very less time after the manufacturing of product. Warehouse receives RFC (Rolling Forecast) every month from the corporate. RFC is a list of products to be dispatched in the month. The same RFC is also sent to the production department for manufacture planning during the month. The whole dispatching process can be shown in form of a simple chart given below
Documentation
41
Meanwhile the dispatching process proceeds, documentation process will also proceeds simultaneously. The list of required documents is given below.
Details of documents for dispatch of finished goods:
Name of document 1 2 3 4 5 6 7 Excise bill in duplicate Stock transfer note Form 402 Form AR-2 for state excise product Lorry receipt Original and triplicate of out pass Form ARE-1 / ARE-2 / AR-4 for export ERP ERP Printed form Printed form MS Excel / open Office, signed by excise inspector Transporter Warehouse Printed form MS Excel / open Office, signed by excise inspector wherever applicable Document source
More ERP based documents 1. QC order 2. Distribution Order 3. Distribution Issue Above mentioned documents are not require to send with dispatched goods, but they are the part of standard procedure to be followed. Dispatch procedure Authorized officer prepares the list of products to be dispatched with full details as per shown below. Item code Description of the item Rate of excise duty to be charged while billing Batch no. Total quantity Total no. of boxes Quantity in loose boxes Retail price per unit Instruction for dispatch:
42
For the dispatch of finished products warehouse follows the RFC. RFC provides the required quantity of various products to be dispatched and emergency in percentage. The product having maximum requirement will produce first and dispatched as soon as possible and other products would be dispatched as per descending order in RFC.
Finished goods release by QA: After the goods receiving in BSR, QA will take samples from the batch. Number of samples depends upon the size of batch. Batch size Up to 2000 2000 to 50,000 Above 50,000 No. of samples 10 50 100
Until the completion of QA analysis ERP system doesn¶t allow further documentation. After the satisfactory result QA make necessary entries in the ERP system and system shows the batch ready to dispatch. Excise Invoice, Transfer Note After QA release warehouse required to prepare Excise Invoice. Because Excise Invoice is a very important document, authorized person refer the checklist given below prior to generate the Excise Invoice. Check List: Destination wise separate product list Total number of shippers and quantity in loose shippers Total quantity = no. of full box * each full box quantity + quantity in loose boxes Note down retail price After the Excise Invoice the next step is to generate Transfer Note from ERP and get it confirmed. Take printout of Excise Invoice as well as Transfer Note and get the same signed. Attach all the relevant documents wherever applicable for the dispatch and get it stamped. Security Out Pass Memo To allow the goods outside of the company premise an authorized security out pass memo has to be generate.
43
Complete the necessary entries for the clearance in daily stock account in proper folio. Before handing over the documents to driver ensure that the vehicle has been covered properly. Material out pass memo would be sent to security in-charge who should check everything in security point of view. The security in-charge should counter check the number of cartons mentioned in the material out pass memo and his deputed guard counted while loading and allow the vehicle outside the premise. The security in-charge should also make the necessary entry in the material outward register and keep the material out pass memo for future reference. Unimed has two depots: 1. Vapi (Gujarat) 2. Bhiwandi (Maharashtra) (Form-402 is required when consignment going to cross the border of state. It is applicable for Bhiwandi, not for Vapi) All the finished products are dispatches to either of these two depots. The next destination of the Product would be C & F agent. A C & F agent forwards the product to SUN Pharma.
44
7. Import
The wide portfolio of Unimed products requires large variety of raw materials from India and foreign. Company imports various raw materials on regular basis from renowned organizations of Europe, America and some other countries. Import procedure is very difficult which includes typical documentation and approval procedure from many different government authorities at the different stages of import. As import procedure became a regular practice at Unimed Company always apply for import at concessional rate of duty So general import is known here as ³import at concessional rate of duty´. Here the flow chart of the whole import procedure is produced in order to present the difficult import procedure in simple form.
IMPORT AT CONCESSIONAL RATE OF DUTY
Application for registration
Application grant
Bond acceptance procedure
Bond accepted by AC/DC
Import at concessional rate of duty
Import
Intimation for import/purchased material
45
Import of goods at concessional rate of duty for manufacture of Excisable goods:
These rules were amended in year 2002 and came into application at the first day of March 2002. Earlier these rules were made in the year 1996 and were start to applied at 1st September 1996. Import Process: 1. Registration: A manufacturer intending to avail of the benefit of an exemption shall obtain a registration from the assistant commissioner of central excise having jurisdiction over his/her factory. The registration shall contain particulars about the name and address of the manufacturer, the excisable goods produced in his factory, the nature and description of imported goods used in manufacture of such goods. Then the assistant commissioner of central excise or deputy commissioner of central excise will issue a certificate to the manufacturer indicate the particulars referred above. 2. Application by the manufacturer to obtain the benefit: A manufacturer who has obtained a certificate and intends to import any goods for use in his/her factory at concessional rate of duty, shall make an application to the assistant commissioner of central excise or deputy commissioner of central excise indicating the estimated quantity and value of such goods to be imported. Applicant shall also provide details of port of import. The manufacturer may at this option, file the application either in respect of a particular consignment or indicating his estimated requirement of such goods for a quarter. The manufacturer shall also give undertaking on the application that the imported goods shall be used for the intended purpose only. The application shall be countersigned by the assistant commissioner or deputy commissioner of central excise who shall certify there in that the manufacturer is registered in his office and has executed a bond to his satisfaction in respect of end use of imported goods in the manufacturer¶s factory and indicate the particulars of such bond. 3. Procedure to be followed by AC / DC of customs: On the basis of application countersigned by assistant commissioner or deputy commissioner of central excise, the assistant commissioner or deputy commissioner of customs at the port of import shall allow the benefit of the exemption notification to the importer. Provided that where the importer has field the application in respect of his estimated requirement for a quarter, that said assistant commissioner of customs or deputy commissioner of customs
46
shall debit in the said application, the quantity and value of import made under a particular consignment, also indicating particulars of the bill of entry, before allowing the benefit of the exemption notification to the importer. The assistant commissioner or deputy commissioner of customs will forward a bill of entry containing the particulars of import, the amount of duty paid and other relevant particulars to the assistant commissioner or deputy commissioner of central excise. 4. Procedure to be followed by AC / DC of central excise: The assistant commissioner or deputy commissioner of central excise shall acknowledge the receipt of intimation received from the assistant commissioner or deputy commissioner of customs. 5. Manufacturer to give information regarding receipt of imported goods and maintain records: The manufacturer shall give information of the receipt of imported goods in his factory, within two days (excluding holidays, if any) of such receipt, to the superintendent of central excise having jurisdiction over his factory. The manufacturer shall also maintain a simple account indicating the quantity and value of goods imported. The quantity of imported goods consumed for the intended purpose and the quantity remaining in stock, bill of entry wise. The organization has to present this account as and when required by the assistant commissioner or deputy commissioner of central excise. 6. Recovery of duty in certain case: The AC/DC of Central Excise shall insure that the goods imported are used by the manufacturer for the intended purpose and in case they are not so used take action to recover the amount equal to the difference between the duties liviable on such goods but for interest, at the rate fixed by notification issued under section 28AB of the customs act, 1962 for the period starting from the date of importation of the goods on which the exemption was availed and ending with the date of actual payment of the entire amount at he difference of duty that he is liable to pay.
47
Documents:
a. Annexure-I Broad description of the exemption notification No. 36/96-cus. b. Annexure-II It is a registration certificate. It shall be obtained from assistant commissioner or deputy commissioner of central excise. Assistant Commissioner of central excise issue the registration certificate in triplicate Annexure-II Original Duplicate Triplicate Registration holder Range superintendent AC of Central Excise
AC holds triplicate copy for reference of his office and send duplicate to superintendent so that he can register the assessee in his office as a authorized importer. c. Annexure-III It is an application form. Each time assessee want to import the raw material, he/she shall obtain the Annexure-III and fill up as per guidelines. After fill up the form he/she need to send the application to superintendent of central excise in quadruplicate copy. Superintendent verifies the application and forwards it to AC of Central Excise. Annexure-III AC of customs Range superintendent AC of central excise for office Registration certificate holder
Original Duplicate Triplicate Quadruplicate
AC endorses the necessary details and forwards the approved application to AC of customs at the port of import (an airport or sea port where imported material will arrive). I.e. factory of applicant is situated at Vadodara but imported material is to arrive at Chennai airport than AC forwards the original approved application to AC of customs at Chennai airport.
48
d. Annexure-IV It is a bond under the customs e. Annexure-V It is an intimation document shows receipt of goods at the factory premise. It should be submitted to superintendent of central excise (having authorization over his/her factory) within two days of receipt of goods at factory.
49
. EXPORT
The export contract
Introduction
Whenever any goods produced in the factory anywhere in India leaves the factory premise, it is liable to excise duty. But in order to promote the export government provide 100% exemption on duty paid by exporter. This way exporter gets relief from 1. 5% basic excise duty 2. 2% of basic duty as education cess 3. 1% secondary and higher secondary education cess Unimed exports its products in countries like, Guyana, Thailand. Mauritius, Netherlands, Algeria, Peru, Russia, South Africa etc. The first step of export is export contract. An export contract (also referred to as a sales contract) is essentially an agreement between exporter and a foreign importer to do business. The export contract can take many different forms. For example: 1. A telephonic offer to sell, covering essential issues such as the product details, quantities offered, price per unit, delivery particulars and payment terms, made by the exporter to the foreign buyer (or an offer to buy from the importer to the exporter) and confirmed by the second party is one example of a legitimate export contract. 2. Similarly, any written offer (quotation), either contained in a formal written contract and posted or couriered to the importer, or sent by e-mail, fax, telex or cable to the importer, and confirmed (usually also in writing) by the importer, is another form of legitimate contract. 3. A Proforma invoice sent by fax, e-mail, courier or post to the importer (usually on his/her request) and confirmed by the importer is another common form of export contract. The confirmation could be as simple as the importer writing "I agree to these terms and
50
conditions" on the proforma invoice and signing it or perhaps the importer may generate a separate, signed document agreeing to the proforma invoice which is then attached as reference.
The first offer is seldom accepted
It is seldom the case that the importer will accept the first offer made by the exporter and normally this first offer will be followed by a series of counter-offers sent back and forth between the exporter and the importer until each party is satisfied with the terms and conditions outlined in the final offer and agree to abide by it.
Be clear and precise
Whatever form the export contract takes, you need to be careful in formulating this document as they are drawn up between companies from countries which may have very different legal systems, regulations and attitudes to doing business. These differences may cause disputes even when trading with other fairly developed nations. The challenge is to make your export contracts as clear, precise and comprehensive as is possible.
The provisions in the contract
The basic provision of any contract for the sale of goods is that you, the seller (in this case, the exporter), will transfer ownership of the goods to your buyer (the importer) in exchange for payment (which, in international trade, made be made in a foreign currency). The export contract needs to specify the terms and conditions for doing this, and should at least describe:
y y y y y y y
Who is party to the contract The validity of the contracts The goods being sold (usually described in some detail) The purchase price of the goods and the currency in question The terms of payment Inspection of the goods if required Where the goods should be delivered
51
y y y y y y y y
At what point transfer of title to the goods takes place Any warranty and/or maintenance conditions associated with the sale Who is responsible for obtaining import or export licenses, if these are required What supporting documentation and/or certificates are required Who is responsible for paying import duties and other taxes Any contract performance security requirements, such as bank letters of guarantee What will happen if either of the parties defaults or cancels The provisions for independent mediation or arbitration to resolve disputes, and whether this would take place in South Africa or the importer's country, or elsewhere
y
The contract's completion date
The role of Incoterms
To provide a common terminology for international shipping and minimize misunderstandings over contract terms, the International Chamber of Commerce has developed a set of terms known as Incoterms. These are the basic terms used in international sales contracts, and you can learn more about them at the Incoterms 2000 Web site or in the Glossary of International Trade Terms in Appendix A.
Intellectual Property (IP)licensing contracts are particularly tricky
If the contract involves the licensing of proprietary information or technology, be very sure that it's precise about the licensee's rights. Vagueness about these rights can create serious problems and can lead to the loss of your intellectual property. If the licensee uses your technology to create other technologies, for example, this can severely undermine the value of your asset.
Contract must be signed by all contracting parties
Also - and this would seem obvious, but it's sometimes overlooked - be sure that all parties to the contract have signed it. For instance, if you're working through a representative, be sure that the actual buyer signs the contract. The representative's signature is not necessarily enough, because without the buyer's signature, there is no written evidence that the buyer owes you money. Last but certainly not least, have the contract examined by a lawyer familiar with the export market.
52
Export process:
In exercise of the powers conferred, the Central Government hereby, directs that rebate of whole of the duty paid on excisable goods (hereinafter referred to as materials¶) used in the manufacture or processing of export goods shall, on their exportation out of India, to any country . (1) Filing of declaration. - The manufacturer or processor shall file a declaration with the Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise having jurisdiction over the factory of manufacture describing the finished goods proposed to be manufactured or processed along with their rate of duty leviable and manufacturing/processing formula with particular reference to quantity or proportion in which the materials are actually used as well as the quality. The declaration shall also contain the tariff classification, rate of duty paid or payable on the materials so used, both in words and figures, in relation to the finished goods to be exported.
(2) Verification of Input±output ratio. ± The Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise shall verify the correctness of the ratio of input and output mentioned in the declaration filed before commencement of export of such goods, if necessary, by calling for samples of finished goods or by inspecting such goods in the factory of manufacture or process. If, after such verification, the Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise is also satisfied that there is no likelihood of evasion of duty, he may grant permission to the applicant for manufacture or processing and export of finished goods.
(3) Procurement of material. ± The manufacturer or processor shall obtain the materials to be utilised in the manufacture of the finished goods intended for export directly from the registered factory in which such goods are produced, accompanied by an invoice under rule 11 of the Central Excise Rules, 2002: Provided that the manufacturer or processor may procure materials from dealers registered for the purposes of the CENVAT Credit Rules, 2002 under invoices issued by such dealers.
53
(4) Removal of materials or partially processed material for processing. ± The Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise may permit a manufacturer to remove the materials as such or after the said materials have been partially processed during the course of manufacture or processing of finished goods to a place outside the factory -
(a) for the purposes of test, repairs, refining, reconditioning or carrying out any other operation necessary for the manufacture of the finished goods and return the same to his factory without payment of duty for further use in the manufacture of finished goods or remove the same without payment of duty in bond for export, provided that the waste, if any, arising in the course of such operation is also returned to the said factory of the manufacture or process; or
(b) for the purpose of manufacture of intermediate products necessary for the manufacture or processing of finished goods and return the said intermediate products to his factory for further use in the manufacture or process of finished goods without payment of duty or remove the same, without payment of duty for export, provided that the waste, if any, arising in the course of such operation is also returned to the factory of manufacturer or processor;
(c) Any waste arising from the processing of materials may be removed on payment of duty as if such waste is manufactured or processed in the factory of the manufacturer or processor.
(5) Procedure for export. - The goods shall be exported on the application in Form A.R.E. 2 specified in the Annexure to this notification and the procedures specified in Ministry of Finance (Department of Revenue) notification No. 42/2001-Central Excise (N.T.), dated the 26th June, 2001 shall be followed.
(6) Presentation of claim of rebate. ± The claim for rebate of duty paid on materials used in the manufacture or processing of goods shall be lodged only with the Assistant Commissioner of Central Excise or Deputy Commissioner of Central Excise having jurisdiction of the place approved for manufacture or processing of such export goods.
54
Documents required for rebate claim:
1. Form R: this form is a application for refund or rebate claim of excise duty 2. Original, Duplicate and Triplicate copy of ARE- 2 3. Duplicate copy of Excise Invoice 4. Self certified true copy of Shipping Bill 5. Self certified true copy of Custom attested Invoice and Packing List. 6. Self certified true copy of Airway Bill.
55
Documentation:
Introduction
The export process is made more complex by the wide variety of documents that the exporter needs to complete to ensure that the order reaches its destination quickly, safely and without problems. Documentation requirements for export shipments also vary widely according to the country of destination and the type of product being shipped. Most exporters rely on an international freight forwarder to handle the export documentation because of the multitude of documentary requirements involved in physically exporting goods and it is strongly recommended that you also make use of a freight forwarder to help you work your way through the maze of documentation.
The benefits of documentation
Documentation is a key means of conveying information from one person or company to another, and also serves as permanent proof of tasks and actions undertaken throughout the export process. If the documentation is complete, accurate, agreed upon by the parties involved and signed by each of these of the parties (or their representatives), the document will represent a legally binding document.
Function of export documentation
Export documentation may serve any or all of the following functions:
y y
An attestation of facts, such as a certificate of origin Evidence of the terms and conditions of a contract if carriage, such as in the case of an airway bill
56
y y y
Evidence of ownership or title to goods, such as in the case of a bill of lading A promissory note; that is, a promise to pay A demand for payment, as with a bill of exchange
Documents required for export:
1. Retail invoice (2 copy) 2. ARE 1(5 copy) 3. ARE 2 (6 copy) 4. COA (Certificate Of Analysis) 5. Commercial Invoice (3 or 5 copy) 6. Packing List 7. Bill of Lading 8. Shipping Bill 9. Certificate Of Origin
Documents required for transport:
1. Bill of lading 2. Airway bill 3. Freight transit note 4. Road consignment note 5. Export cargo shipping instruction
Documents required for payment:
1. Commercial Invoice 2. Letter of credit 3. Transport documents
Insurance documents:
1. Marine insurance
57
Introduction to all the documents:
1. Certification:
Introduction In exporting, it is quite common for cargos to require a variety of certificates, including certificates of origin, certificates of value, certificates of health, Consular certificates, etc. before they are permitted to be imported into the country of destination. The purpose of a certificate is to provide preshipment confirmation of the status of a particular aspect (health, value, condition, origin, etc.) of a specific cargo. Certificates of origin A Certificate of Origin (C/O) is required by some countries and is intended to certify to the importing authorities as to which country the products being imported were manufactured in that is, the C/O certifies that the imported product meets the 'Country of Origin' requirements set by the importing country and which are expected of their foreign suppliers. It may be required that the C/O include information such as local material and labour content. Certificates of Value (and Origin) A Certificate of Value is intended to confirm the value of a cargo to assist in quick clearing of the goods in the country of destination. Often the Certificate of value is combined with a Certificate of Origin and is referred to as a Certificate of Value and Origin (CVO). A CVO outlines details about the labor and packing costs, royalties or commissions (if applicable), freight charges and any overseas insurance costs. The CVO also provides an exporter's declaration and statement, in the form of clauses, about the value and origin of the goods. Fumigation certificate Some countries, such as Australia, Canada, New Zealand, the US and the UK, are very strict about letting in goods that might contain bacteria or insects that could harm their agriculture. Fumigation certificates usually contain details such as purpose of treatment, the articles in
58
question, temperature range used, chemicals and concentration used, etc. Sometimes they may be required for sea shipments, but not for air shipments. Certificates of health Certificates of health are normally required by the importing country to ensure that the imported goods (plants, plant products, animals and animal products) are in good health and carry no diseases, pests or any health-threatening organisms. Such certificates of health confirm (a) The origin of the shipment and, (b) That local authorities have inspected the consignment and ensure its good health. Certificates of Health can be divided into two types:
y
Phytosanitary certificates which are required for the import of certain plants and plant products such as seeds and flowers.
y
Veterinary certificates which are required for the import of live animals, as well as fresh, chilled or frozen animal products. For contact details go to.
Pre-shipment inspection certificates It is not uncommon for importers to want to confirm that the to-be-exported goods meet their requirements. This is particularly so in instances where it is essential that the goods meet certain standards, they may: a. Require that the shipment be inspected just before loading by an independent third-party arranged and generally paid for by the importer. b. Ask the exporter to obtain the pre-shipment inspection certificate from an independent third-party inspection firm which is then forwarded to the importer. The independent contractor - usually a recognized firm in this field - will undertake a detailed inspection of equipment or materials after manufacture, but prior to shipment. The scope of the inspection includes quantity and quality, packing and marking and supervision of loading.
59
2. The Airway bill Air waybills (AWB) are a form of BOL (Bill Of Lading) and are used for both domestic and international flights. An AWB (also referred to as air consignment note or airway bill of lading) refers to a documentary receipt issued by a carrier (i.e. airline) in favor of a shipper for goods received and is evidence of the contract of carriage to carry the goods to a specified airport under specified conditions, but it is not a document of title to the goods. It serves as:
y y y
Proof of receipt of the goods for shipment Evidence of the contract of carriage An invoice for the freight, reflecting the shipper, the consignee and the goods being shipped, as well as the full freight amount
y y y
A certificate of insurance (if carriers insurance is requested by the shipper) A guide to airline staff for the handling, dispatch and delivery of the consignment A means of clearing the goods through customs
Usually, the AWB consists of three originals and nine copies. The first original is intended for the carrier (airline) and is signed by the exporter (or agent); the second original ± the consignee's copy ± is also signed by the exporter (or agent) and accompanies the goods; the third original is signed by the carrier and is handed to the exporter (or agent) as a receipt for the goods after they have been accepted for carriage. Types of air waybills There are two types of air waybills used for the international transportation of air cargo:
y y
The "airline air waybill", with preprinted issuing carrier identification, The "neutral air waybill" without preprinted identification of the issuing carrier in any form and used by other bodies than air carriers (such as freight forwarder).forma invoice
60
3. Proforma invoice Introduction A Proforma invoice is little more than a pre advice of what will stand in the commercial invoice once negotiations have been completed. The proforma invoice serves as a negotiating instrument. The initial proforma invoice often sets the stage for the first round of negotiations if the exporter and importer have not yet had any real discussions. Role of the Proforma Invoice. Only one final proforma invoice is necessary to confirm that the two parties are indeed in agreement. Every proforma invoice should be as precise and as explicit as possible to ensure that both parties understand each other. If the importer is satisfied with this final proforma invoice, he/she will request their bank to issue an L/C on the strength of information stipulated in the proforma invoice. Details pertinent to the proforma invoice The following details are pertinent to the setting up of the proforma invoice and need careful attention:
y y y y y y
A complete and clear description of the goods in question The quantity of goods in question including the number and kinds of packaging involved The total price of the goods (and unit price where applicable) The currency in which the goods will be sold (e.g. US dollars or rands) The likely delivery schedule and delivery terms The physical addresses of both the exporter (referred to as the shipper) and importer (sometimes referred to as the consignee)
y y y
The payment methods, for example cash in advance or L/C The payment terms, for example 30 days on sight The Incoterm to be used
61
y
Who is responsible for the banking fees and other related costs (insurance and freight costs are covered by the Inco term in question)
y y y
The exporter's banking details The country of origin of the goods The expected country of final destination
4. Commercial invoice Introduction After the pro-forma invoice is accepted, the exporter must prepare a commercial invoice. The commercial invoice is required by both the exporter and importer. In exporting, the commercial invoice is considered a very important document as it serves as the starting document that underpins an export transaction. The commercial invoice is essentially a bill from the seller to the buyer describing the goods to be sold and the terms involved. The commercial invoice will normally be presented on the exporter's letterhead and will be addressed to the importer. It should contain full details of the consignment, including price and other related costs, in order to facilitate customs clearance. It must be signed and dated. What should appear in the commercial invoice? The following details need to appear in the commercial invoice: The name of the shipper/exporter and their contact details, including physical address The name of the importer/consignee and their contact details, including physical address An order number of reference to correspondence between the supplier and importer A complete and clear description of the goods in question (including brandmarks and the HS number)
y y
y y y y
The packing details unless provided in a separate packing list The quantity of goods in question including the number and kinds of packaging involved
62
y
The external dimensions, cubic capacity, weight, numbers and contents of each package shipped.
y
The total price of the goods (and unit price where applicable) usually quotes as a CIF/FOB price
y y y y y y y
The currency in which the goods will be sold (e.g. US dollars or rands) The type and amount of discount given The likely delivery schedule and delivery terms The payment methods, for example cash in advance or L/C The payment terms, for example 30 days on sight The Incoterm to be used Who is responsible for the banking fees and other related costs (insurance and freight costs are covered by the incoterm in question)
y y y y y y
What the freight and insurance charges are The exporter's banking details A declaration of the country of origin of the goods The expected country of final destination Any freight details such as the port of loading and discharge Any other information relevant to the order
5. Letter of credit In this section we discuss the following topics and terminology within the area of documentary credits: Sight credits This is an easy enough term to explain. A sight credit or L/C is one which paid upon presentation of the required documentation to the issuing or confirming bank. An exporter need to be careful however, as some L/Cs state that payment will only be made at a specified branch counter of the issuing or confirming.
63
Usance credits An L/C can specify any credit period that you have negotiated with the importer. A letter of credit that that incorporates a payment after a given term (e.g. 60 days) is known as a usance credit (also referred to as a term or acceptance credit). Transferable credits An irrevocable L/C may also be transferable. In the case of a transferable L/C, the exporter can transfer all or part of his/her rights to another party. Transferable letters of credit are often used when the exporter is the importer's agent or a middleperson (i.e. export agent) between supplier and importer, and not the actual supplier of merchandise. With a transferable letter of credit, the exporter uses the credit standing of the issuing bank and avoids having to borrow or use his own funds to buy goods from a supplier. Revolving credits The term "revolving" is used to describe a letter of credit, which, incorporates a condition whereby the credit amount is to be renewed or reinstated automatically without the need for a specific amendments to the credit. This type of credit is used when regular trade is conducted between an exporter and an overseas buyer. A revolving credit can be irrevocable or confirmed. Back-to-back credits When an exporter, who is not a manufacturer, but obtains goods from a supplier by acting as an export agent for the supplier for example, has received an L/C from an importer, the exporter, in turn, may request his bank to open a L/C in favour of his supplier on the strength of the existing L/C. These two credits are said to be "back-to-back", that is to say the one is issued on the security of the other. Standby credits A standby L/C is one which is issued in favour of the exporter for the purpose of "backing-up" certain specified obligations of the importer. A standby letter of credit requires the exporter's
64
presentation of documents which indicate that importer has not met the obligations which the standby letter of credit backs-up. 6. Packing lists: Introduction When you prepare your goods for shipment, you will be required to prepare a detailed export packing list. This is a formal document that itemizes quite a number of details about the cargo such as:
y y y y y y y y y
Name and contact details The importer's/consignee's/buyer's name, address and contact details The gross, tare and net weights of the cargo The nature, quality and specifications of the product being shipped The type of package (such as pallet, box, crate, drum, carton, etc.) The measurements/dimensions of each package The number of pallets/boxes/crates/drums, etc. The contents of each pallet or box (or other container) The package markings, if any, as well as shipper's and buyer's reference numbers
The purpose of the packing list The packing list should be attached to the outside of a package in a waterproof envelope or plastic sheath marked "Packing list enclosed". The list is used by the shipper or forwarding agent to determine (1) the total shipment weight and volume and (2) whether the correct cargo is being shipped. Be careful while preparing packing list It is important for you to realize that any mistake on the packing list may cause a delay in clearance at the port of destination. Customs Authorities in the target country have the right to delay the clearance of the shipment until the importer provides a packing list reflecting the real contents of the container.
65
7. Road consignment note: The road consignment note is :
y y y
Proof of receipt of the goods for transportation by road Evidence of the contract of carriage An invoice for the freight, reflecting the shipper, the consignee and the goods being shipped, as well as the full freight amount
y y
A guide to the road hauler for the handling, dispatch and delivery of the consignment A means of clearing the goods through customs
To clear the goods through customs, the road consignment note will need to be accompanied by a commercial invoice, a packing list and any other documentation relevant for clearing purposes.
A Freight Transit Order (FTO) is a form of inland BOL used in South Africa and required by Spoornet, the primary rail operator in the country. Transport documents and special Instructions Spoornet has the following to say about transport documents:
y
y
y
. Freight transit order:
Spoornet shall only accept goods into its care if it has been timeously furnished with fully completed transport documents, or the relevant Electronic Data Interchange information, by the consignor who warrants that all information reflected on the transport documents is accurate in all respects. The consignor shall indemnify Spoornet and hold it harmless against all losses, damages, expenses and fines arising from any inaccuracy or omission made by the Consignor in the transport documents. Wherever it is necessary, for the purpose of these conditions or any other purpose whatever, for special instructions such as stoppage or diversion of goods to be given to Spoornet, such instructions shall only be recognised by Spoornet as valid if they are timeously given and agreed to by Spoornet.
66
9.
Bill of lading (BOL or B/L):
Introduction A BOL is one of the oldest and most common forms of transportation documents in use today. It is a document that establishes the terms of a contract between a shipping company (or its agent) and the exporter/shipper (or agent, such as a freight forwarder). Within this contract, it is agreed that freight is to be moved between specified points for a specified charge. Some more detail The BOL is normally completed by the exporter on forms issued by the shipping carrier. The BOL serves as a document of title, a contract of carriage, and a receipt for goods. The BOL also describes the kind and quantity of goods being shipped (such as the number of packages, the weight and consignment dimensions), the shipper (or exporter), the consignee (the person or firm to whom the goods are being shipped), the ports of loading and discharge, and the carrying vessel. Key points of BOLs The key points that exporter should take note of, are:
y
The BOL is a legal contract between the shipper (normally the exporter) and carrier (the shipping line represented by the ship¶s master or shipping line representative)
y
As a legal document, the BOL plays an important role in releasing payment from the bank in conjunction with the Letter of Credit
y
A BOL is a document issued by a carrier, e.g. a ship's master or by the carrier¶s shipping department, or a representative of either of these two
y y y
The BOL must be signed or authenticated by the person issuing the document The BOL must name the ship/vessel carrying the goods The BOL does not afford the holder of the document any ownership of the goods listed in the document (it is not a negotiable document)
y
The BOL acknowledges that specified goods have been received on board as cargo for conveyance
67
y y y y
The BOL specifies both the ports of loading and discharge The BOL normally has a named consignee The BOL will specify the goods to be conveyed, their number, weight and volume BOLs are usually issued in three originals; one for the exporter/shipper, one for the shipping line and one for receiver/consignee of the goods.
10. ARE 1: It is annexure 14: application for removal of excisable goods for export. Original and Duplicate copies of ARE 1 are sent with dispatch. Triplicate copy goes to range superintendent. Superintendent signs the copy and forwards to custom. Quadruplicate copy retains with range superintendent for official use. Quintuplicate copy retains with consigner.
11. ARE 2:
Combined for rebate
application of duty
for paid on
removal excisable
of
goods
for used in
export the
under manufacture
claim and
materials
packing of such goods and removal of dutiable excisable goods for export under claim for rebate of finished stage Central Excise Duty or under bond without payment of finished stage Central Excise Duty leviable on export goods. Original and Duplicate copies are sent with dispatch. Both the copies are signed by customs and returned back to the consigner. Other copies would be presented as a proof of export at the time of rebate claim.
68
ATTACHMENTS
1. ARE 1
ANNEXURE-14
Range........... Division..............Address..................... Commissionerate.................... Original (White) Duplicate (Buff) Triplicate (Pink) Quadruplicate (Green)
FORM A.R.E. 1 Application for removal of excisable goods for export by (Air/Sea/Post/Land)*
To Superintendent of Central Excise ........................(Full Postal Address) 1. Particulars of [Assistant/Deputy Commissioner of Central Excise]/Maritime Commissioner of Central Excise from whom rebate shall be claimed/with whom bond/undertaking is executed and his complete postal address. 2. I/We........ Of ..............propose to export the under-mentioned consignment to ........... (Country of destination) by Air/Sea/Land/Parcel Post under claim for rebate/bond/undertaking*.
Particulars of Manufacturer of goods-and his Central Excise Registration No.
Gross No. and Description weight/Net of packages weight
Marks and Nos. on packages
Quantity of goods
Description of Goods
(1)
(2)
(3)
(4)
(5)
(6)
69
Duty Value Rate (7) (8) Amt. (Rs.) (9)
No. and date of Invoice under which duty was paid/No. Amount of Remarks and date of bond/undertaking executed under Rule 19 Rebate claimed (10) (11) (12)
3. I/We hereby certify that the above- mentioned goods have been manufactured. (a) availing facility/without availing facility of CENVAT credit under CENVAT Credit Rules, 2001 (b) availing facility/without availing facility under Notification 41/2001-CE(N.T.), dated 26th June, 2001 issued under rule 18 of Central Excise(No.2) Rules, 2001. (c) availing facility/without availing facility under Notification 43/2001-CE(N.T.), dated 26th June, 2001 issued under rule 19 of Central Excise(No.2) Rules, 2001. 4. I/We hereby declare that the export is in discharge of the export obligation under a Quantity based Advance Licence/ /Under Claim of Duty Drawback under Customs & Central Excise Duties Drawback Rules, 1995. 5. I/We hereby declare that the above particulars are true and correctly stated. Time of Removal.................................. Signature of owner or his Authorised agent with date. Name in Block Letters & Designation (SEAL)
PART A
Certification by Central Excise Office
1. Certified that duty has been paid by debit entry in the Personal Ledger Account No. .........and/or CENVAT Account Entry No............ or recorded as payable in Daily Stock Account, on the goods described overleaf. OR Certified that the owner has entered into Bond No. ............ under Rule 19 of Central Excise (No.2) Rules, 2001 with the........................«««.[F.No.___________________], duly
70
accepted by the Assistant Commissioner/Deputy Commissioner of Central Excise________ on _________(Date). 2. Certified that I have opened and examined the packages No.....«««««««««......... and found that the particulars stated and the description of goods given overleaf and the packing list (if any) are correct and that all the packages have been stuffed in the container No. ............... with Marks .................. and the same has been sealed with Central Excise Seal/One Time Seal(OTS) No. ............. 3. I have verified with the records, the exporter is only availing the export incentives, as specified in box No.6. and found it to be true. 4. Certified that I have drawn three representative samples from the consignment (wherever necessary) and have handed over, two sets thereof duly sealed to the exporter/his authorised representative. Place..................... Date ......................
Signature (Name in Block Letters) Superintendent of Central Excise Signature (Name in Block Letters) Inspector of Central Excise
PART B
CERTIFICATION BY THE CUSTOMS OFFICER
Certified that the consignment was shipped under my supervision under Shipping Bill No_______ dated _______by S.S./Flight No.________ which left on the_______ day of________ (Month)__________(year) OR Certified that the above-mentioned consignment was stuffed in Container No._____________________ belonging to Shipping Line_____________ based on the ´Let Export Orderµ given on ____________day of.________(Month)__________year) on the Shipping Bill No______ dated__________ and sealed by seal/one time lock No._______________ in my supervision and the container was handed over to the Custodian M/s_____________________ for being shipped via ___________________(Name of the Port). OR Certified that the above-mentioned consignment has been duly identified and has passed the land frontier today at_______________ in its original condition under Bill of Exports No______________ Place_____________ Date_____________.
Signature
71
(Name and designation of the Customs Officer in Block Letters)/(Seal)
PART C
EXPORT BY POST
Certified that the consignment described overleaf has been despatched by foreign post to ««««««««« on......................day of 200«««.
Place «««.. Date «««.
Signature of Post Master (Seal)
PART D
REBATE SANCTION ORDER
(On Original, Duplicate and Triplicate) Refund Order No««««««.. dated «««««««.. Rebate of Rs«««««.. (Rupees «««««««««««««««..) sanctioned vide Cheque No. ««««««dated «««««««
Place «««.. Date «««.
Assistant/Deputy Commissioner/Maritime Commissioner of Central Excise
72
2. ARE 2
ANNEXURE-23
ARE 2 No.______________ Original (White) Duplicate (Butff) Triplicate (Pink) Quadruplicate (Green) Quintuplicate (Blue)
Form A.R.E. 2 Combined application for removal of goods for export under claim for rebate of duty paid on excisable materials used in the manufacture and packing of such goods and removal of dutiable excisable goods for export under claim for rebate of finished stage Central Excise Duty or under bond without payment of finished stage Central Excise Duty leviable on export goods.
To The Superintendent of Central Excise. (Address) ___________________ (full postal address) 1. Particulars of the Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise from whom rebate shall be claimed/ with whom bond is executed and his complete postal address __________________ 2. I / We______________ of ________________ propose to export the under mentioned goods (details of which are given in Table 1 below) to_________________ (country of destination) by *air/sea/land/post parcel* under claim for rebate of duty paid on excisable materials used in the manufacture and packing of such goods. 3. *The finished goods being exported are not dutiable or We intended to claim the rebate of Central Excise Duty paid on clearances of goods for export under notification 40/2001-CE(N.T.), dated 26th June, 2001 issued under Rule 18 of Central Excise (No.2) Rules, 2001.
or The Export goods are intended to be cleared without payment of Central Excise Duty under notification 42/2001-CE(N.T.), dated 26th June, 2001 issued under Rule 19 of Central Excise (No.2) Rules, 2001.
73
TABLE - 1 (Details of goods to be exported)
Net Weight Descri Marks Sl. Gross and ption of &Nos. on No. Weight quantity packages packages of goods** (1) (2) (3) (4) (5)
Finished Stage Central DescriInvoice Excise Duty ption of Value No. & finished date goods Rate Amount (6) (7) (8) (9) (10)
Bond/ Undertaking executed under rule 19(if any) (11)
Amount of Rebate Remarks Claimed under Rule 18 (12) (13)
*Strike out portion not applicable **Quantity of goods to be furnished in units of sale where it is different than weight. #Write NA where exports are under bond/letter of undertaking in terms of Rule 19 or where goods are not chargeable to duty
TABLE 2
Details of duty paid excisable Materials and Packing materials used in manufacture of export goods for which rebate under notification _________ dated_________is being claimed
Name/ description of Central Name Sl. materials/packing Excise Unit Qty.used of No. with technical Tariff Supplier specification/ Subheading Quantity (1) (2) (3) (4) (5) (6)
Total Wastages Duty Invoice Rate of Assessable Amt. No. & Central Value/Unit per ReIrreValue/Unit Excise Rs. unit coverable coverable Rs. duty Rs. (7) (8) (9) (10) (11) (12)
Reb adm und Rule Rs.
(13)
Declaration : a. We hereby certify that we have not availed facility of CENVAT credit under CENVAT Credit Rules, 2001
74
b. We hereby declare that the export is not in discharge of export obligation under a Value based Advance Licence issued prior to 31.03.95 c. We hereby declare that the materials on which input stage rebate in claimed are not sought to be imported under a Quantity Based Advance Licence issued prior to 31.03.95. d. We further declare that we shall not claim any Drawback on export of the consignment covered under this application. e. I / We hereby declare that the above particulars are true and correctly stated. f. We have been granted permission by Assistant Commissioner of Central Excise or Deputy Commissioner of Central Excise vide
C.No.__________ date __________ for working under Notification ____________ dated ______ .
Time of Removal __________________
Signature of owner or his authorised agent with date Name in Block Letters & Designation SEAL Note 1: The A.R.E. 2 should be submitted by the manufacturer at least 24 hours intended removal of goods for export, to the superintendent of Central Excise. Note 2: A running serial of the factory starting with one every financial year should be allotted to every A.R.E. 2
FOR DEPARTMENT USE PART A CERTIFICATION BY THE CENTRAL EXCISE OFFICER
1. Certified that *duty has been paid on the goods described above or duty is payable as recoded at entry number___ in Daily Stock Account. or *the owner has entered into B-1 bond No ____________ /given an Undertaking ______under Rule 19 of Central Excise (No.2) Rules, 2001 with the_______________________ or *the finished goods being exported are not dutiable 2. Certified that I have opened and examined the packages No. ___________________ and found that the particulars stated and the description of goods given overleaf read with the invoice and the packing list (if any) correct *[and that all the packages have been stuffed in the container No._______________ with Marks ________________]*and the same has been sealed with Central Excise Seal/*One Time Seal (OST) No.__________ 3. I have verified with the records, the declaration of the manufacture given at Sl. No. 3 overleaf regarding non availment of credit under rule CENVAT Rules and found it to be true.
75
4. Certified that I have drawn three representative samples from the consignment and have handed over two sets thereof thereof duty sealed to the manufacturer/ his authorised representative. (wherever feasible) 5. Certified that the material consumption's indicated in Table 2 overleaf are in accordance with the declaration No. _____________filed by__________on___________ Place : __________________ Date : __________________ Signature (Name in Block Letters) Superintendent of Central Excise Signature (Name in Block Letters) Inspector of Central Excise *Strike out inapplicable portions Note 3 : The details given in table 2 may be verified by the Superintendent of Central Excise subsequent to clearances. For this purpose a detailed verification report may be submitted by the Superintendent to the Assistant Commissioner of Central Excise along with Triplicate copy of A.R.E. 2 Note 4 : The original -duplicate and sixtuplicate shall be returned to the manufacturer for presenting to the Customs Officer.
PART B Certification by the Customs Officer
1. Certified that I have examined the consignment described overleaf, and the seals on the packages were found intact and I have satisfied myself that particulars of the consignment are as specified overleaf except for the shortages mentioned below:
2. Certified that the exports are not under Duty Drawback Scheme. It is further certified that exports are not in discharge of export obligation under Value Based Advance Licence or a Quantity Based Advance Licence issued before 31.03.95. 3. Certified that all copies of Shipping Bill / Bill of export contain endorsement of A.R.E. 2 No. in the space provided for indicating ARE 1. 4. Certified that the consignment was shipped under my supervision under *Shipping Bill No. / Bill of Export No. ____________ _____________dated___________ which left for _____________ on __________/ which passed the frontier on ____________ 5. Duplicate copy of A.R.E. 2 Forwarded to Assistant/Deputy Commissioner of Central Excise .................. on ..................... Place Date
76
Signature (Name and designation of the Customs Officer in Block letters) (Seal)
Note 5 : The customs shall send the duplicate to the address given at Sl. No. 1 over leaf and handover original and sixtuplicate to the exporter.
PART C* Rebate Sanction Order Under Rule 18(1) (On Original, Duplicate and Triplicate)
Refund Order No. ______________ dated ______________ Rebate of Rs. ___________ (Rupees _____________ sanctioned vide cheque No.___________ dated ____________ Place ______________ Date ______________ Assistant/Deputy Commissioner of Central Excise
PART D Rebate Sanction Order under rule 18(2) (On Original, Duplicate and Triplicate)
Refund Order No. _______________ dated ______________________ Rebate of Rs. ____________________ (Rupees ________________________________ sanctioned vide cheque No._________________ dated____________ Place __________________ Date _______________ Assistant/Deputy Commissioner of Central Excise
77
3. Commercial Invoice
1. EXPORTER 2. CONSIGNEE 3. INTERMEDIATE CONSIGNEE - The name and address of the party who effects delivery of the merchandise to the ultimate consignee, or the party so named on the Export License. 4. FORWARDING AGENT 5. COMMERCIAL INVOICE NO.
78
6. CUSTOMER PURCHASE ORDER NO. 7. B/L, AWB NO. 8. COUNTRY OF ORIGIN 9. DATE OF EXPORT 10. TERMS OF PAYMENT 11. EXPORT REFERENCES 12. AIR/OCEAN PORT OF EMBARKATION 13. EXPORTING CARRIER/ROUTE 14. PACKAGES - Record number of packages, cartons, or containers per description line. 15. QUANTITY - Record total number of units per description line. 16. NET WEIGHT/GROSS WEIGHT - Record total net weight and total gross weight 17. DESCRIPTION OF MERCHANDISE 18. UNIT PRICE/TOTAL VALUE 19. PACKAGE MARKS 20. MISC. CHARGES 21. CERTIFICATIONS
79
4. Proforma invoice
80
5. Packing list
81
doc_152179589.docx