1. QUALITY ASSURANCE AND QUALITY MANAGEMENT CONCEPTS
2. TOTAL QUALITY MANAGEMENT (TQM)
3. ICH GUIDELINES
4. QUALITY BY DESIGN (QBD)
5. ISO 9000 AND ISO 14000
6. NABL ACCREDITATION
7. ORGANIZATION AND PERSONNEL
8. PREMISES
9. EQUIPMENT’S AND RAW MATERIALS.
10. QUALITY CONTROL TESTS FOR PACKAGING MATERIAL
11. GOOD LABORATORY PRACTICES
12. COMPLAINT, RETURN GOODS, RECALL AND WASTE DISPOSAL
13. DOCUMENT MAINTENANCE IN PHARMACEUTICAL INDUSTRY
14. CALIBRATION AND VALIDATION
15. WAREHOUSING AND MATERIALS MANAGEMENT
ANNEXURES (Document Format used Industry)
MODEL QUESTION PAPERS
BIBLIOGRAPHY KEY WORD INDEX