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Course Title QUALITY CONTROL AND QUALITY ASSURANCE
Course Code MQA103T
Course Credit Lecture :4
Tutorial :0 Total :4
Course Objectives
Upon completion of this course the student should be able to
Understand the cGMP aspects in a pharmaceutical industry To appreciate the importance of documentation To understand the scope of quality certifications applicable to Pharmaceutical industries To understand the responsibilities of QA & QC departments.
Detailed Syllabus
Sr. Hours Name of Chapter & Details No. Allotted
1 Introduction: Concept and evolution and scopes of Quality Control and 12
Quality Assurance, Good Laboratory Practice, GMP, Overview of ICH Guidelines - QSEM, with special emphasis on Qseries guidelines. Good Laboratory Practices: Scope of GLP, Definitions, Quality assurance unit, protocol for conduct of non clinical testing, control on animal house, report preparation and documentation. CPCSEA guidelines.
2 cGMP guidelines according to schedule M, USFDA (inclusive of CDER and 12
CBER) Pharmaceutical Inspection Convention(PIC), WHO and EMEA covering: Organization and personnel responsibilities, training, hygiene and personal records, drug industry location, design, construction and plant lay out, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination and Good Warehousing Practice.
3 Documentation in pharmaceutical industry: Three tier documentation, 12
Policy, Procedures and Work instructions, and records (Formats), Basic principles- How to maintain, retentionband retrieval etc. Standard operating procedures (How to write), Master Batch Record, Batch Manufacturing Record, Quality audit plan and reports. Specification and test procedures, Protocols and reports. Distribution records. Electronic data handling. Concepts of controlled and uncontrolled documents. Submission documents for regulators DMFs, as Common Technical Document and Electronic Common Technical Documentation (CTD, eCTD). Concept of regulated and non-regulated markets.
4 Analysis of raw materials, finished products, packaging materials, in 12
process quality control (IPQC), Developing specification (ICH Q6 and Q3), purchase specifications and maintenance of stores for raw materials.In process quality control and finished products quality control for following dosage forms in Pharma industry according to Indian, US and British pharmacopoeias: tablets, capsules, ointments, suppositories, creams, parenterals, ophthalmic and surgical products (How to refer pharmacopoeias).
5 Manufacturing operations and controls: Sanitation of manufacturing 12
premises, mix-ups and cross contamination, processing of intermediates and bulk products, packaging operations, IPQC, release of finished product, process deviations, charge-in of components, time limitations on production, drug product inspection, expiry date calculation, calculation of yields, production record review, change control, sterile products, aseptic process control, packaging, reprocessing, salvaging, handling of waste and scrap disposal. Introduction, scope and importance of intellectual property rights. Concept of trade mark, copyright and patents.
Instructional Method and Pedagogy:
Lectures will be conducted with the aid of multi-media projector, black board, OHP etc. Assignments based on course content will be given to the students at the end of each unit/topic and will be evaluated at regular interval. Surprise tests/Quizzes/Seminar/Tutorials will be conducted which carries 5% component of the overall evaluation. The course includes language practices such as Group Discussion, Interviews etc to develop the communication skills of the students.
Reference Books:
1. Quality Assurance Guide by organization of Pharmaceutical Procedures of India, 3rd
revised edition, Volume I & II, Mumbai, 1996. 2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69, Marcel Dekker Series, 1995. 3. Quality Assurance of Pharmaceuticals- A compedium of Guide lines and Related materials Vol I & II, 2nd edition, WHO Publications, 1999. 4. How to Practice GMP’s – P P Sharma, Vandana Publications, Agra, 1991 5. The International Pharmacopoeia – vol I, II, III, IV & V - General Methods of Analysis and Quality specification for Pharmaceutical Substances, Excepients and Dosage forms, 3rd edition, WHO, Geneva, 2005. 6. Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38, Marcel Dekker Series, 1989. 7. ICH guidelines 8. ISO 9000 and total quality management 9. The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 4 th edition, Susmit Publishers, 2006. 10. QA Manual – D.H. Shah, 1st edition, Business Horizons, 2000. 11. Good Manufacturing Practices for Pharmaceuticals a plan for total quality control – Sidney H. Willig, Vol. 52, 3rd edition, Marcel Dekker Series. 12. Steinborn L. GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 1 - With Checklists and Software Package). Taylor & Francis; 2003. 13. Sarker DK. Quality Systems and Controls for Pharmaceuticals. John Wiley & Sons; 2008. 14. Packaging of Pharmaceuticals. 15. Schedule M and Schedule N.
