PHARMACEUTICAL VALIDATION AND QUALITY MANAGEMENT SYSTEM

Transcription

1 Course Title Course Code PHARMACEUTICAL VALIDATION AND QUALITY MANAGEMENT SYSTEM QA204 Lecture : 04 Course Credit Practical : 04 Tutorial : 00 Total : 08 Course Objective To explain the students about various concepts of validation, designing of validation protocol and validation documents. This course will provide students insight into validation of various equipments, methods, formulations and building, quality management system, quality audits, concept of total quality management etc. Detailed Syllabus Theory Sr. No. 1 Name of chapter & Details Section I Introduction to Pharmaceutical Validation: Definition, Approaches to validation and scope of validation, Advantage of Validation, importance of Validation, Limitation of Validation, Organization for Validation, Validation Master plan, Calibration Master plan, Design Qualification, Installation Qualification, Operational Qualification & Performance Qualification of facilities. Differences and similarities between process qualification and process validation, protocols, methodology and interpretation of data, calibration Hours Allotted 07

2 & verification. 2 Validation of Building and facilities: (DQ, IQ, OQ, PQ) 03 3 Types of process validation (prospective, retrospective & concurrent) 02 4 Analytical Method Validation: 03 General principles of analytical method validation for dosage forms. (accuracy, precision, specificity, linearity, range, robustness etc.) 5 Validation of following formulations: - Coated tablets - Capsules - Ointment/Creams - Liquid Orals 05 Validation of manufacturing process for sterile and non-sterile products (protocols and reports) 6 Validation of Pharmaceutical equipments/apparatus, Validation of following 03 equipment: - Tablet Compression (Machine) - Autoclaves - Capsule filling machines. 7 Validation of following analytical Instruments: 04 - HPLC - Dissolution test apparatus - U.V./Visible spectrophotometers 8 Validation of computerized systems, ERP and SAP systems. 03 Section II 9 Vendor validation: Vendor audit, sample testing and trend analysis, Vendor Certification 02

3 Utilities Validation: a. Validation of Pharmaceutical Water System & pure steam b. Validation of HVAC system c. Validation of Compressed air Cleaning Validation: Validation of effective cleaning. (sampling procedure and acceptance criteria) Cleaning of Equipment and Facilities Quality management system: Related Quality System: ISO, WHO and their application in pharmaceutical Industry. Concept of Total Quality Management, Six Sigma methodology, ISO Controls on four M responsible for Quality variation in Pharmaceutical products. Auditors, auditing strategies and preparation of audits, quality audit and audit checklists and auditing of manufacturing facilities by international regulatory agencies. Conducting and handling of internal/domestic/international regulatory audits/customer specific audits/ pre approval inspections. Quality evaluation and batch release: Change control, deviation- (planned and unplanned), corrective action and preventive action (CAPA), handling of non-conformance, vendor evaluation process, out of specification (OOS), batch reconciliation and finished goods release Pharmaceutical Validation And Quality Management System (Practical) 1. Calibration of Volumetric glasswares 2. Calibration of Analytical balance 3. To perform Calibration of UV-Visible Spectrophotometer. 4. Validation of following equipment Like Autoclave, Hot air oven, Powder Mixer (Dry), Filter, Dissolution Tester, Tablet Compression Machine. 5. Development and Validation of Analytical method (minimum two exercises).

4 6. Validation of a processing area. 7. Validation of at least two analytical instruments. 8. Cleaning validation of one equipment. 9. Validation of processes like mixing, drying and compression. 10. Formulation Development & its validation. 11. Bio-analytical method development and its validation 12. Preparation of SOPs for various equipments and manufacturing processes as per ISO requirements. 13. Documentation for audits and inspection of manufacturing facilities 14. Documentation for inprocess and finished products quality control tests for solid, semisolid and sterile preparations 15. Protocol preparation for purchase of manufacturing equipments and raw materials 16. Protocol preparation for documentation of various types of record (BFR, MFR, DR, etc.) 17. Quality control tests on solid, liquid, semisolid and sterile dosage forms 18. Any other relevant exercises based on theory. 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. Students Learning Outcomes: At the completion of the course students should be able: 1. To know various approaches of validation and calibration. 2. To know validation of various equipments involved in manufacturing or analysis of pharmaceuticals. 3. To carry out validation of various formulations. 4. To carry out validation of various analytical methods, utilities and vendor.

5 5. To understand concept of total quality management, six sigma, quality audit, ISO etc. Text books: 1. J. R. Berry and R.A. Nash, Pharmaceutical process validation. 3rd Ed Marcel Dekker, B. T. Loftus & R. A. Nash, "Pharmaceutical Process Validation", Drugs and Pharm Sci. Series, Vol. 129, 3rd Ed., Marcel Dekker Inc., N.Y. 3. ISO 9000 and Total Quality Management Sadhank G Ghosh 4. Total quality management, principles, implementation and Cases, Sharma D. D., Sulatan Chand And Sons, New Delhi, Fundamentals of Total Quality Managemnt, process analysis and improvement by Jens. J Daulgard, Kai Kriestensen and gopal K. Kanji. Taylor and Francis 6. The Theory & Practice of Industrial Pharmacy, 3rd edition, Leon Lachman, Herbert A. Lieberman, Joseph. L. Karig, Varghese Publishing House, Bombay Reference Books: 1. S. Weinberg, Good laboratory practice Regulations, Marcel and Dekker. 2. J. Swarbrick Boylan, encyclopedia of pharmaceutical technology, Marcel and Dekker. 3. S. H. Will and J.R. Stoker, good manufacturing Practices for Pharmaceutics Marcel Dekker. 4. R. F. Brewer, Design of experiments for process improvement and quality Assurance, Narrosa. 5. Validation Master plan by Terveeks or Deeks, Davis Harwood International publishing. 6. F.J. Carleton and J.P. Agalloco validation of aseptic Pharmaceutical processes Marcel and Dekker. 7. Validation of active Pharmaceutical Ingredients by, I.R. Berry and Daniel Harpar. 8. Analytical Method validation and Instrument Performance Verification by Churg Chan, Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Interscience. 9. Pharmaceutical Master Validation plan by S. Haiden, CRC press. 10. Validation of pharmaceutical process by Conleton F.

6 11. Sidney H. Willig, "Good Manufacturing Practices for Pharmaceuticals", Drugs and Pharm. Sci. Series, Vol. 109, Marcel Dekker Inc., N.Y. 12. GLP quality audit manual, Milton A. Anderson, Third edition, Informa Healthcare 13. Laboratory auditing for quality and regulatory compliance, by Donald C. Singer, Stefan and Stedan, Drugs and pharmaceutical sciences, Vol Laboratory auditing for quality and regulatory compliance, by Donald C. Singer, Taylor and Francis. 15. ICH guidelines 16. D. H. Stamatis, Understanding ISO 9000 and implementing the basics to quality; Marcel Dekker. 17. ISO issues and implementation Lamplecht J.A. 18. Implementing ISO 14000: a practical, comprehensive guide to the ISO environmental management standards, Authors: Tom Tibor, Ira Fldman, Editors: Tom Tibor, Ira Feldman, Irwin Professional Pub., Total quality management, Dale H. Besterfield, Pearson Education, 3 rd edn., I. R. Berry, Daniel Harpaz, Validation of Active Pharmaceutical Ingredients. 21. Total Quality Managemnt, organization, and strategy, James R. Evans, Thomson, 4 th Edn Additional Resources 1. Research journals and Internet sources