Definition and concept of Qualitycontrol, 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
: 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 test for containers, rubber closures and secondary packing141 materials. Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of aNonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities
Complaints and evaluation of complaints, Handling of return good, recalling andwaste 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.
Introduction, definition and general principles of calibration, qualification and validation, importance and scope of validation, types of validation, validationmaster plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation. Warehousing: Good warehousing practice, materials management
Reference Book:
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
Text Book:
Quality Assurance Guide by organization of Pharmaceutical Products of India. 2. Good Laboratory Practice Regulations, 2 nd 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.
