GMP Compliance Adviser Contents

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The GMP Compliance Adviser is divided into two areas: GMP in Practice and GMP Regulations:

GMP in Practice

1. Quality Management Systems
2. Personnel
3. Premises
4. Facilities and Equipment
5. Pharmaceutical Water
6. Qualification
7. Process Validation
8. Cleaning Validation
9. Computer System Validation
10. Hygiene
11. Production
12. Sterile Production
13. Packaging
14. Laboratory Controls
15. Documentation
16. Research and Development
17. Contractors and Suppliers
18. Inspections
19. Quality Risk Management
20. Continual Improvement
21. Active Pharmaceutical Ingredients
22. Excipients
23. Medical Devices
24. Storage and Transportation

GMP Regulations

A. Adresses
B. National Bodies and Pharmaceutical Associations
C. EU Directives and Guidelines
D. USA: CFR and FDA Guidelines
E. ICH-Guidelines
F. PIC/S Guidelines
G. GMP of other Regions
- Canadian Regulations
- Japanese Regulations
- Chinese Regulations
- Indian Regulations
- Australian Regulations
- Brazilian Regulations
H. WHO Guidelines




- Update history
- GMP Abbreviations
- GMP Glossary
- Contributors

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