abhishreshthaa
Abhijeet S
The Q.C. / Q.A. team thoroughly monitors all the processes as per the GMP norms. The respective are carried out as per SOPs written for each of them.
1) AREA: All the areas are monitored for their environmental quality which is confirmed by exposing agar plates and microbial counts are checked regularly. Swab Tests are carried out where required.
2) PERSONNEL: Medical check-up are carried out for all employees regularly to ensure general good health. Personnel with infections or any illness are not allowed in processing area till the infection or illness subsides.
3)WATER: Raw water, Distilled Water and Demineralised water are analysed for all quality Parameters as per pharmacopoeia and specification including microbial analysis before being used in batch manufacturing or for testing purpose .
4) All Raw / Packing materials received are analysed as per specifications and released for manufacturing / packing only after approval by Q.C. Department
5) Manufacturing is carried out in accordance with the Standard Operating Procedure (SOP) and Master Formula. In-process checks are carried out at every stage to ensure the quality of products and the process. The entire processes of manufacturing with special emphasis on the critical processes are recorded in the ‘Batch Manufacturing Records'.
6) CHEMICAL TESTING: Raw material / Finished products / Semi-finished products are analysed chemically as per laid down specification.
7) INSPECTION: Products are inspected for any physical defects and are certified and cleared for packing after in-process by Quality Control.
8) PACKING: Regular checks are carried out during packing to ensures that the products are not affected by environmental conditions and transportation.
9) RELEASE OF FINISHED PRODUCTS: Each batch of finished product is analyzed as per the established analytical specification, and ensured that it complies with the laid down standards. Batch manufacturing record is then checked with respect to various in-process checks performed and properly documented along with the reconciliation (if any ) record and batch yield at various stages. After approving the batch record, the said batch is released. Simultaneously released memo is sent to the concerned department for the dispatch for the batch.
10) DISTRIBUTION: Packed goods released by quality assurance are stacked product / batch wise on metal pallets. Only on receipt of control release memo for the batch, the goods are then dispatched to the different parties as per the requirement. A record of dispatching goods from each lot is maintained by the distribution department, which facilitates in case of a product recall of a particular batch. This record includes the following details:-
(1) Date of dispatch.
(2) Name of the product and its batch number.
(3) Quantity dispatched.
(4) Name of the party to which goods are dispatched.
11) COMPLAINT HANDLING: An established procedure is followed in handling of complaints. Complaints file is maintained by quality assurance department in which the following information's are recorded:-
(1) Name of the product and its batch number.
(2) Name of the complaints.
(3) Nature of complaint.
(4) Remark of Investigation.
(5) Action taken.
(6) Reply to the complaint.
In case of recall of a batch, the distribution department helps in prompt and complete recall the batch. Measures are taken to avoid reoccurrences.
12) VALIDATION: Prospective Validation programme for new equipments installed and retrospective validation for already installed equipments are carried out as per a scheduled validation programme. The existing products are validated using the records of the manufactured batches and the new products are validated prospectively.
13) DOCUMENTATION: A "Documentation Cell" prepares documents under guidance and supervision of Q.A. Manager and Factory Manager e.g. Master Formula Record, SOPs, Specification, etc. In case of any change required in such documents, they are revised only after approval of Q.A. Manager. All absolete documents are called back by Q.A. Manager from work places and kept under lock and key in Q.A. Department for record purpose.
14) MAINTENANCE: A team of maintenance personnel ensures smooth operation of all equipments and machines. Maintenance schedules for equipment and machineries are prepared and adhered to. Preventive maintenance programme are well planned and followed.
1) AREA: All the areas are monitored for their environmental quality which is confirmed by exposing agar plates and microbial counts are checked regularly. Swab Tests are carried out where required.
2) PERSONNEL: Medical check-up are carried out for all employees regularly to ensure general good health. Personnel with infections or any illness are not allowed in processing area till the infection or illness subsides.
3)WATER: Raw water, Distilled Water and Demineralised water are analysed for all quality Parameters as per pharmacopoeia and specification including microbial analysis before being used in batch manufacturing or for testing purpose .
4) All Raw / Packing materials received are analysed as per specifications and released for manufacturing / packing only after approval by Q.C. Department
5) Manufacturing is carried out in accordance with the Standard Operating Procedure (SOP) and Master Formula. In-process checks are carried out at every stage to ensure the quality of products and the process. The entire processes of manufacturing with special emphasis on the critical processes are recorded in the ‘Batch Manufacturing Records'.
6) CHEMICAL TESTING: Raw material / Finished products / Semi-finished products are analysed chemically as per laid down specification.
7) INSPECTION: Products are inspected for any physical defects and are certified and cleared for packing after in-process by Quality Control.
8) PACKING: Regular checks are carried out during packing to ensures that the products are not affected by environmental conditions and transportation.
9) RELEASE OF FINISHED PRODUCTS: Each batch of finished product is analyzed as per the established analytical specification, and ensured that it complies with the laid down standards. Batch manufacturing record is then checked with respect to various in-process checks performed and properly documented along with the reconciliation (if any ) record and batch yield at various stages. After approving the batch record, the said batch is released. Simultaneously released memo is sent to the concerned department for the dispatch for the batch.
10) DISTRIBUTION: Packed goods released by quality assurance are stacked product / batch wise on metal pallets. Only on receipt of control release memo for the batch, the goods are then dispatched to the different parties as per the requirement. A record of dispatching goods from each lot is maintained by the distribution department, which facilitates in case of a product recall of a particular batch. This record includes the following details:-
(1) Date of dispatch.
(2) Name of the product and its batch number.
(3) Quantity dispatched.
(4) Name of the party to which goods are dispatched.
11) COMPLAINT HANDLING: An established procedure is followed in handling of complaints. Complaints file is maintained by quality assurance department in which the following information's are recorded:-
(1) Name of the product and its batch number.
(2) Name of the complaints.
(3) Nature of complaint.
(4) Remark of Investigation.
(5) Action taken.
(6) Reply to the complaint.
In case of recall of a batch, the distribution department helps in prompt and complete recall the batch. Measures are taken to avoid reoccurrences.
12) VALIDATION: Prospective Validation programme for new equipments installed and retrospective validation for already installed equipments are carried out as per a scheduled validation programme. The existing products are validated using the records of the manufactured batches and the new products are validated prospectively.
13) DOCUMENTATION: A "Documentation Cell" prepares documents under guidance and supervision of Q.A. Manager and Factory Manager e.g. Master Formula Record, SOPs, Specification, etc. In case of any change required in such documents, they are revised only after approval of Q.A. Manager. All absolete documents are called back by Q.A. Manager from work places and kept under lock and key in Q.A. Department for record purpose.
14) MAINTENANCE: A team of maintenance personnel ensures smooth operation of all equipments and machines. Maintenance schedules for equipment and machineries are prepared and adhered to. Preventive maintenance programme are well planned and followed.