Table of Contents
Acknowledgements iii
Foreword v
Introduction vii
References ix
1. Management and Supervision Responsibilities 1
2. Quality Risk Management 15
3. Knowledge Management and Organizational Learning 37
4. Quality Management and Quality Systems 51
5. Product and Process Monitoring 71
6. Discrepancy Observation and Investigation 85
7. Complaints 101
8. Qualification and Validation 119
9. Learning, Training, and Performance 149
10. Documentation, Records, and Recordkeeping 171
11. Change Management 197
12. Corrective Action and Preventive Action (CAPA) 213
13. Materials and Packaging Components 227
14. Vendors, Third Parties, and Outsourcing 241
15. Sampling 261
16. Sample Preparation and Analysis 283
17. Testing and Analysis / QC Laboratory Operations 303
18. Equipment Cleaning 331
19. Sanitation 345
20. Facilities and Utility Systems 355
21. Warehousing and Storage 371
22. Distribution Practices 383
23. Maintenance, Repair, and Calibration 413
24. Materials Receiving 425
25. Equipment 439
26. Manufacturing and Packaging: GMP Concepts 451
27. Manufacturing and Packaging: Operations 471
28. Identity Control 489
29. Label Control 503
30. Batch Release 523
31. In-Process Controls 539
32. Aseptic Operations 553
33. Clothing and Personal Hygiene 583
About the Author 595
Recommended Reading 597