Description
data management, inventory management, Stability Information System, Quality Assurance , Laboratory Automation, Chromatography Systems are some topics discussed in detail
Computers In Pharmaceutical Technology
Overview
? Introduction ? Computer Application in Pharmacy ? Supercomputers in Pharmacy ? Regulatory Issues
Affecting Use Of Computer
? Future Trends
? Recent Developments
Introduction
? Impact of computer science on various fields ? Impact of computer science on product
manufacturing to sales and marketing
? computers are so ubiquitous in
pharmaceutical research and development
Computer Applications
? Computers are being successfully utilized in
pharmaceutical technology
?
To improve productivity
?
To collaborate with other professionals
To provide solutions for time-consuming manual tasks
?
Process Control
Data and information Management Systems
Group Collaboration Tools
Laboratory Automation
Computer Applications
Document Management & Publishing Systems
Communication Aids Problem Solving Applications
Internet-based Applications & Tools
Computer Applications in Pharmaceutical Technology
Data and Information Management Systems
? Use of computers for computational purposes ? S/W and H/W rapid development ? DBMS package
development e.g. Oracle, Sybase, and Microsoft Access
? Truckloads of data and documents are need to be
submitted
? Built by the in-house data processing department or
acquired from a vendor to meet the needs of users in a given organization
Data and information Management Systems
Material Inventory System
Formulation Information System
Clinical Supplies Inventory System
Stability Information Systems
Analytical Information Systems
Quality Assurance Information System
Various Data and Information Management Systems
Material Inventory System
? Maintains running inventory of raw materials ? Updated at regular intervals ? Tracking existing inventory, lot no., quantity of
raw materials etc.
Formulation Information System
? Stores lot no. of ingredients, amount/dosage
form, %composition, weight of batch etc.
? Manufacturing summary, shipping history
also stored
? Different retrieval methods- greatest benefit ? Formulation screening studies
Clinical Supply Inventory System
? To provide necessary clinical supplies in a
timely manner
? To plan for the manufacture of needed
supplies
Stability Information System
? Organization and retrieval of stability studies
data
? To establish expiry date for the product ? To generate stability calendar
?
Using this calendar samples are retrieved and sent for analysis
Analytical Information System
? Vast amount of data generated while developing
analytical methods, formulation development etc.
? Analytical laboratory needs sample management in
addition to data management
? Provides list of samples to be analyzed, reports of
analysis, cumulative analytical data etc.
?
e.g.- LIMS
Quality Assurance Information System
? To track information on chemicals, raw
materials, package components, intermediate and finished products.
? Maintains information on lot no., assigned in-
house name, name of manufacturer, date sampled, release status etc.
? Use system to compare generated test data
with specifications.
Group Collaboration Tools
? Intranets ? Used for
? ?
Effective sharing of information Online meetings to collaborate on projects
? Archive project documentation
? Provide capabilities for searching information across several
projects with ease.
? Collaboration between geographically distributed
pharmaceutical R&D and manufacturing plants on process technology data and information.
Document Management and Publishing Systems
? Size of a typical new drug application ? Development of software tools ? Provide control and access to documents in a
collaborative environment
? Help publish electronic and paper copies of
submissions
Internet-Based Applications and Tools
? Easy navigation of the Internet
? Need of Software applications for data
collection, analysis, browsing, and reporting ? Software that gathers patient enrollment status information and certain types of clinical trial data ? Search tools to query information currently available on the Internet ? Examples: Alta Vista, Excite and HotBot
Problem-Solving Applications
? Computer is an excellent tool for statistical
analysis of data ? Commercial software packages - Statistical analysis
?
? ?
Spreadsheet Software Expiry Date Prediction Pharmacokinetics
Communication Aids
? Computer - An excellent tool for
communication
? Store information entered by one user and
send a signal to another user who then reads the information
? Computer a powerful and effective
communication medium for organizations with various remote locations
Cont..
? Example:
?
?
Electronic mail Distributed Information Management Systems
Laboratory Automation
? Built-in microprocessors that process data
collected on samples and display or send the answer to a computer ? Interface that attaches to an external computer for processing the data generated by the instrument
? ? ?
Chromatography Systems Automated Dissolution Systems Microprocessor-based Balances
Chromatography Systems
? CDS (Chromatographic Data Systems)
? Role of chromatography in pharmaceutical analysis ? High-Performance Liquid Chromatography (HPLC) ? Gas Chromatography (GC)
? CDS used in other instrumental analysis technologies ? Ion (exchange) Chromatography (IC) ? Capillary Electrophoresis (CE) ? Supercritical Fluid Chromatography (SFC)
Product Atlas Cerity Chromeleon Class VP
Vendor Thermo Electron Co. Agilent Technologies, Inc. Dionex Co. Shimadzu Scientific Inst.
Website www.thermolabsystem s.com www.agilent.com www.dionex.com www.shimadzu.com
Empower EZChrom Elite Galaxie TotalChrom
Waters Co Scientific Software, Inc
Varian Inc. Perkin-Elmer, Inc.
www.waters.com www.scisw.com
www.varianinc.com www.perkinelmer.com
Snapshot of HPLC
Process Control
? Computerized process-control systems are
used to
? ? ?
Measure process variables through sensors at predefined intervals Make appropriate decisions Take appropriate actions to keep the process under control
? Limited by the availability of pharmaceutical
processing equipment
Cont..
? Example
?
?
Automated Tableting Automated Freeze-drying
Automated Tableting
? Useful ? To develop compression profiles for reference purposes ? To control weight of tablets during development and production ? To monitor punch wear ? Automation reduces the burden on personnel
faced with the requirements of quality control. ? Example:
?
Merck Sharp and Dohme in UK
Automated Freeze-drying System
? Uses PC and a programmable logic controller ? PC - initiates the process, monitors the process, maintains recipes, and archive data. ? Programmable logic controller - Controls the freezedrying, sterilization, and cleaning process by means of instructions downloaded from the PC ? Avoids long freezing times ? Eliminates the need for human operator intervention
during transition from one freeze-drying phase to the other. ? Helps in process documentation and in developing cost-effective freeze-drying profiles
Supercomputer in Pharmacy
? Molecular Modeling for Drug Design ? Bioinformatics ? Biomolecular Docking ? Ab-initio Methods
Cont..
? Genome Sequence Analysis
? Gene Finding
? Microarray Data Analysis
? Problem Solving Environment (PSE)
Regulatory Issues Affecting Use of Computers
? Regulatory authority - FDA ? Validation ? Computerized systems to be validated ? Manufacturers comply with regulations that
cover electronic records and signatures
Future trends
Recent Developments
? Ultra High Performance Liquid
Chromatography in Contract Manufacturing Environment
? Use of Wireless Technology
References
? Encyclopedia of Pharmaceutical Technology,
Third Edition, Vol. 1, edited by James Swarbrick ? Computer application in Pharmaceutical Research and Development, Ekins, Sean Editor - Ekins, Sean, John Wiley & Sons Inc ? www.pharmainfo.net/reviews ? http://books.google.com/books ? www.informaworld.com
? www.rtidemo.org
Thank You
doc_484814594.ppt
data management, inventory management, Stability Information System, Quality Assurance , Laboratory Automation, Chromatography Systems are some topics discussed in detail
Computers In Pharmaceutical Technology
Overview
? Introduction ? Computer Application in Pharmacy ? Supercomputers in Pharmacy ? Regulatory Issues
Affecting Use Of Computer
? Future Trends
? Recent Developments
Introduction
? Impact of computer science on various fields ? Impact of computer science on product
manufacturing to sales and marketing
? computers are so ubiquitous in
pharmaceutical research and development
Computer Applications
? Computers are being successfully utilized in
pharmaceutical technology
?
To improve productivity
?
To collaborate with other professionals
To provide solutions for time-consuming manual tasks
?
Process Control
Data and information Management Systems
Group Collaboration Tools
Laboratory Automation
Computer Applications
Document Management & Publishing Systems
Communication Aids Problem Solving Applications
Internet-based Applications & Tools
Computer Applications in Pharmaceutical Technology
Data and Information Management Systems
? Use of computers for computational purposes ? S/W and H/W rapid development ? DBMS package
development e.g. Oracle, Sybase, and Microsoft Access
? Truckloads of data and documents are need to be
submitted
? Built by the in-house data processing department or
acquired from a vendor to meet the needs of users in a given organization
Data and information Management Systems
Material Inventory System
Formulation Information System
Clinical Supplies Inventory System
Stability Information Systems
Analytical Information Systems
Quality Assurance Information System
Various Data and Information Management Systems
Material Inventory System
? Maintains running inventory of raw materials ? Updated at regular intervals ? Tracking existing inventory, lot no., quantity of
raw materials etc.
Formulation Information System
? Stores lot no. of ingredients, amount/dosage
form, %composition, weight of batch etc.
? Manufacturing summary, shipping history
also stored
? Different retrieval methods- greatest benefit ? Formulation screening studies
Clinical Supply Inventory System
? To provide necessary clinical supplies in a
timely manner
? To plan for the manufacture of needed
supplies
Stability Information System
? Organization and retrieval of stability studies
data
? To establish expiry date for the product ? To generate stability calendar
?
Using this calendar samples are retrieved and sent for analysis
Analytical Information System
? Vast amount of data generated while developing
analytical methods, formulation development etc.
? Analytical laboratory needs sample management in
addition to data management
? Provides list of samples to be analyzed, reports of
analysis, cumulative analytical data etc.
?
e.g.- LIMS
Quality Assurance Information System
? To track information on chemicals, raw
materials, package components, intermediate and finished products.
? Maintains information on lot no., assigned in-
house name, name of manufacturer, date sampled, release status etc.
? Use system to compare generated test data
with specifications.
Group Collaboration Tools
? Intranets ? Used for
? ?
Effective sharing of information Online meetings to collaborate on projects
? Archive project documentation
? Provide capabilities for searching information across several
projects with ease.
? Collaboration between geographically distributed
pharmaceutical R&D and manufacturing plants on process technology data and information.
Document Management and Publishing Systems
? Size of a typical new drug application ? Development of software tools ? Provide control and access to documents in a
collaborative environment
? Help publish electronic and paper copies of
submissions
Internet-Based Applications and Tools
? Easy navigation of the Internet
? Need of Software applications for data
collection, analysis, browsing, and reporting ? Software that gathers patient enrollment status information and certain types of clinical trial data ? Search tools to query information currently available on the Internet ? Examples: Alta Vista, Excite and HotBot
Problem-Solving Applications
? Computer is an excellent tool for statistical
analysis of data ? Commercial software packages - Statistical analysis
?
? ?
Spreadsheet Software Expiry Date Prediction Pharmacokinetics
Communication Aids
? Computer - An excellent tool for
communication
? Store information entered by one user and
send a signal to another user who then reads the information
? Computer a powerful and effective
communication medium for organizations with various remote locations
Cont..
? Example:
?
?
Electronic mail Distributed Information Management Systems
Laboratory Automation
? Built-in microprocessors that process data
collected on samples and display or send the answer to a computer ? Interface that attaches to an external computer for processing the data generated by the instrument
? ? ?
Chromatography Systems Automated Dissolution Systems Microprocessor-based Balances
Chromatography Systems
? CDS (Chromatographic Data Systems)
? Role of chromatography in pharmaceutical analysis ? High-Performance Liquid Chromatography (HPLC) ? Gas Chromatography (GC)
? CDS used in other instrumental analysis technologies ? Ion (exchange) Chromatography (IC) ? Capillary Electrophoresis (CE) ? Supercritical Fluid Chromatography (SFC)
Product Atlas Cerity Chromeleon Class VP
Vendor Thermo Electron Co. Agilent Technologies, Inc. Dionex Co. Shimadzu Scientific Inst.
Website www.thermolabsystem s.com www.agilent.com www.dionex.com www.shimadzu.com
Empower EZChrom Elite Galaxie TotalChrom
Waters Co Scientific Software, Inc
Varian Inc. Perkin-Elmer, Inc.
www.waters.com www.scisw.com
www.varianinc.com www.perkinelmer.com
Snapshot of HPLC
Process Control
? Computerized process-control systems are
used to
? ? ?
Measure process variables through sensors at predefined intervals Make appropriate decisions Take appropriate actions to keep the process under control
? Limited by the availability of pharmaceutical
processing equipment
Cont..
? Example
?
?
Automated Tableting Automated Freeze-drying
Automated Tableting
? Useful ? To develop compression profiles for reference purposes ? To control weight of tablets during development and production ? To monitor punch wear ? Automation reduces the burden on personnel
faced with the requirements of quality control. ? Example:
?
Merck Sharp and Dohme in UK
Automated Freeze-drying System
? Uses PC and a programmable logic controller ? PC - initiates the process, monitors the process, maintains recipes, and archive data. ? Programmable logic controller - Controls the freezedrying, sterilization, and cleaning process by means of instructions downloaded from the PC ? Avoids long freezing times ? Eliminates the need for human operator intervention
during transition from one freeze-drying phase to the other. ? Helps in process documentation and in developing cost-effective freeze-drying profiles
Supercomputer in Pharmacy
? Molecular Modeling for Drug Design ? Bioinformatics ? Biomolecular Docking ? Ab-initio Methods
Cont..
? Genome Sequence Analysis
? Gene Finding
? Microarray Data Analysis
? Problem Solving Environment (PSE)
Regulatory Issues Affecting Use of Computers
? Regulatory authority - FDA ? Validation ? Computerized systems to be validated ? Manufacturers comply with regulations that
cover electronic records and signatures
Future trends
Recent Developments
? Ultra High Performance Liquid
Chromatography in Contract Manufacturing Environment
? Use of Wireless Technology
References
? Encyclopedia of Pharmaceutical Technology,
Third Edition, Vol. 1, edited by James Swarbrick ? Computer application in Pharmaceutical Research and Development, Ekins, Sean Editor - Ekins, Sean, John Wiley & Sons Inc ? www.pharmainfo.net/reviews ? http://books.google.com/books ? www.informaworld.com
? www.rtidemo.org
Thank You
doc_484814594.ppt