Name of Chapter & Details. Section-I

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1 Course Title Course Code INTRODUCTION TO QA AND DOCUMENTATION QA1 Lecture : Course Credit Practical : 00 Tutorial : 00 Total : Course Objectives To explain the students about quality control, quality assurance, documentation and their role in quality assurance. This course will provide students insight into quality assurance department in the pharmaceutical industry, role of quality assurance department in today s context and how important this department is in any pharmaceutical set up. Detailed Syllabus - Theory Sr. No. Name of Chapter & Details Hours Allotted 1 Section-I Introduction: An understanding of the concepts of quality assurance, Good Manufacturing Practice and quality control as applied to the pharmaceutical industry. 2 Introduction to Good Manufacturing Practices: Schedule M

2 (India), CFR 21 Part 210 and 211 of US FDA,EU, GCC, Korea, Australia, Health Canada. a. Organization & personnel, responsibilities, training, hygiene and personal records. b. Premises: Location, design, plant layout, construction, maintenance and sanitation, environmental control, utilities and services like gas, water, maintenance of sterile areas, and control of contamination. c. Equipments: Selection, identification, purchase specifications, maintenance, clean in place, sterilize in place, methods (TP & STP). d. Raw Materials: Purchase specifications, maintenance of stores, selection of vendors, control on raw materials and finished dosage forms. e. In process quality controls on various dosage forms: sterile and non sterile, standard operating procedures for various operations like cleaning, filling, drying, compression, coating, disinfections, sterilization, membrane filtration etc. f. Pharmaceutical Packaging: Introduction to pharmaceutical packaging, types of packaging material, testing of packaging materials. Quality control of packaging material such as glass, plastic, papers. Quality control test for containers, closures, caps and secondary packaging materials. Packaging and labeling control, line clearance, reconciliation of labels, cartons and other packaging materials. etc Section-II

3 3 4 5 Good Manufacturing Practices: g. Quality Control Laboratory: Responsibilities of quality control laboratory- Good Laboratory Practices (GLP), routine controls, instruments, reagents, sampling plans, standard test procedures, protocols for clinical and non - clinical testing and control on animal houses, data generation and storage, quality control documents, retention samples, records, audits of quality control facilities, application of computers in quality control and quality assurance laboratory h. Finished product release, quality review, quality audits and batch release documents. i. Warehousing, design, construction, maintenance and sanitation; good warehousing practice, materials and management. Post operational activities: Distribution and distribution records Complaints and adverse effects, evaluation of complaints, complaint handling, recalls, recall procedures, related records and documents, handling of returned goods, recovered materials and reprocessing, drug product salvaging. Sampling plans, methods and statistical analysis of data generated. Documentation in pharmaceutical industry: Documentation required as per revised Schedule M, importance of documentation, preparation, issue and use of documents, storage, retention, retrieval and disposal of documents and records, Preparation of SOP s and documents related to calibration and validation of equipments, validation protocols. Preparation of

4 manufacturing documents like, MFR, BMR, BPR, Site master file, Quality audit, Quality Review and Quality documentation, Reports and documents, distribution records. Specifications for materials, intermediates and finished product. Dossier structure for quality part- ACTD, ICH-CTD, Electronic submission 02 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. The course includes language practices such as group discussion, interviews etc. to develop the communication skills of the students. Students Learning Outcomes: At the completion of the course, students will be able to: 1. Know manufacturing requirements as per Schedule M. 2. Know various post operational activities like distribution, handling of returned goods, recovered materials and reprocessing, complaints and adverse effects, recalls, evaluation of complaints, recall procedures, related records and documents, sampling plans, methods and statistical analysis of data generated. 3. Know documentation required as per schedule M for preparation, issue and use of documents, storage, retention, retrieval and disposal of documents and records, preparation of SOP s and documents related to calibration and validation of equipments.

5 Text Books: 1. P. P.Sharma How to practice GMPs, 3rd edition Vandana Publication. 2. P. P. Sharma How to practice GLP Vandana Publication. 3. Pharmaceutical Quality Assurance, M.A. Potdar, Nirali Prakashan, Pune. 4. Current Good Manufacturing Practices, M.A. Potdar, Pharma-Med Press, Hyderabad. 5. Good laboratory practice and regulations by Mohanan P.V. Reference Books: 1. Sidney H. Willig, "Good Manufacturing Practices for Pharmaceuticals", Drugs and Pharm. Sci. Series, Vol. 109, Marcel Dekker Inc., N.Y. 2. S. Bolton, "Pharmaceutical Statistics: Practical & Clinical Applications", Drugs and Pharm. Sci. Series, Vol. 135, 4th Ed., Marcel Dekker Inc., N.Y 3. G. S. Banker & C.T. Rhodes, "Modern Pharmaceutics", Drugs and Pharm. Sci. Series, Vol. 121, 4th Ed., Marcel Dekker Inc., N.Y. 4. S. Weinberg, Good Laboratory Practice Regulation Drugs and Pharm. Sci. Series, Vol. 124, 2nd Ed., Marcel Dekker Inc., N.Y. 5. WHO s Drug Bulletins. 6. Remingtons Pharmaceutical Sciences. 7. GMP practices for pharmaceutical-james Swarbrick. 8. Quality Assurance Guide by organization of Pharmaceutical Products of India. 9. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol-I, WHO Publications. 11. Garfeild Quality Assurance Principles of Analytical Laboratories. 12. Quality manual by D.H. Shah, 1 st edn, business Horizons, Regulatory guidelines related to GMP by a. Australian code of GMP for medicinal products, 16 th Aug

6 b. 21 Code of Federal Regulation, parts 210, 211 & 58. (USFDA guidelines) c. MHRA, UK Guidelines on GMP d. GMP Guidelines by Medicines Control Council of South Africa Schedule M of D & C Act 14. Assurance of Quality, Pharmaceutical Total Quality Approach, M. S. P. Khan, Chitgaon, Bangladesh, Signet Press Pharmaceutical Packaging, F.A.Paine. 16. Quality Control of Packaging Materials in the Pharmaceutical Industry, Kenneth & Harburn, Marcel Decker Inc. 17. Guidelines on cgmp and Quality of Pharmaceuticals product by S. Iyer. 18. Handbook of Packaging Engineering, edition- II by J. F. Hanlon. 19. Packaging of pharmaceutical and health care products by H. Lockhart, Frank A. Paine. 20. Good laboratory practices by Weinberg sandy. 21. Good clinical laboratory and manufacturing by Carson P.A. Additional Resources 1. Official websites of regulatory authorities and other internet sources