Knowledge is power!

Wie auch der GMP-BERATER ist das GMP MANUAL in zwei Bereiche aufgeteilt:
GMP in Practice und GMP Regulations.

Hier finden Sie die Inhalte:

GMP in Practice

1. Pharmaceutical Quality System (PQS)
2. Personnel
3. Premises
4. Facilities and Equipment
5. Pharmaceutical Water
6. Qualification
7. Process Validation
8. Cleaning Validation
9. Computer System Validation
10. Considerations on Risk Management
11. Production
12. Sterile Production
13. Packaging
14. Laboratory and Analytical Controls
15. Documentation
16. Research and Development
17. Contractors and Suppliers
18. Inspections
19. Quality Unit
20. Continual Improvement
21. Active and Inactive Ingredients
22. Biologics
23. Medical Devices

GMP Regulations

A. Empty Register
B. Empty Register
C. EU Directives and Guidelines
D. USA: CFR and FDA Guidelines
E. ICH-Guidelines
F. PIC/S Guidelines
G. GMP of other Regions (this
chapter is supplied on CD-ROM
and online only)
- WHO Guidelines
- Health Canada - GMP Guidelines
- Japanese Regulations
H. Information

>>> Sehen Sie hier das vollständige Inhaltsverzeichnis

Das GMP MANUAL ist erhältlich als

GMP MANUAL Online Named User Licence oder Corporate Licence

GMP MANUAL Paper Version incl. CD-ROM

GMP MANUAL CD-ROM