Contents:
1. Quality Assurance, Quality Management and GMP 2. Total Quality Management 3. ICH Guidelines 4. Ich Stability Testing Guidelines and Proceudures 5. Quality by Design (QbD) 6. ISO 9000 and ISO 14000 7. Validation in cGMP 8. Good Manufacturing Practices (GMP) -
Part 1 (Introduction, Summary, Organization, Personnel and Premises) 9. Good Manufacturing Practices (GMP) -
Part II (Equipment and Raw Materials) 10. Good Manufacturing Practices (GMP) -
Part III (Documentation and Records) 11. Good Manufacturing Practices (GMP) -
Part IV 12. Pharmaceutical Packaging and Quality Control Tests of Packaging Materials 13. Good Laboratory Practices (GLP) 14. Calibration and Validation of Analytical Instruments 15. Warehousing and Materials Management |