Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance and GMP Total Quality Management (TQM): Definition, elements, philosophies ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines Quality by design (QbD): Definition, overview, elements of QbD program, tools ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration NABL accreditation : Principles and procedures
Organization and personnel: Personnel responsibilities, training, hygiene and personal records. Premises: Design, construction and plant layout, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination. Equipments and raw materials: Equipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials.
Quality Control: Quality control test for containers, rubber closures and secondary packing materials. Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities
Complaints: Complaints and evaluation of complaints, Handling of return good, recalling and waste disposal. Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and documents, distribution records.
Calibration and Validation: Introduction, definition and general principles of calibration, qualification and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation. Warehousing: Good warehousing practice, materials management
Reference Book:
1. Quality Assurance Guide by organization of Pharmaceutical Products of India. 2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69. 3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol I WHO Publications. 4. A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh 5. How to Practice GMP’s – P P Sharma. 6. ISO 9000 and Total Quality Management – Sadhank G Ghosh 7. The International Pharmacopoeia – Vol I, II, III, IV- General Methods of Analysis and Quality specification for Pharmaceutical Substances, Excipients and Dosage forms 8. Good laboratory Practices – Marcel Deckker Series 9. ICH guidelines, ISO 9000 and 14000 guidelines
Text Book:
Quality Assurance by Prof. Dr. R. Sundhararajan, Dr. M. V. Kumudhavalli, Dr. (Mrs). Minal T. Harde
