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Advantage for you

Reasons to buy the GMP MANUAL:

#1 Benchmark your procedures


#2 Regulations and Interpretations in one convenient source

 

#3 The only current GMP knowledge source that has THE AUTHORITY

 

#4 More than 10,000 satisfied users around the globe

 

#5 Training Material

 

more advantages ...

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GMP Knowledge

Thinking about GMP compliance should put your mind at ease.

Prepare yourself by using a tool that is trusted by thousands of regulators and other professionals in the pharmaceutical industry worldwide:

With the GMP MANUAL, you have the information you need to make sure your GMP program is the best it can be. It is presented in two parts:

GMP in Practice is written in a concise manner by noted industry experts according to international GMP regulations. Numerous approaches and examples of problem-solving are included. More than 700 checklists, templates and SOPs examples are included.

GMP Regulations contain important, continuously updated GMP regulations from Europe, USA, Japan, PIC/S, ICH and WHO. Each regulation has a separate index. It provides examples, templates and includes numerous checklists, figures and cross-references.

Both parts are updated regularly.

Contents of the GMP MANUAL

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. Quality Risk Management
11. Production
12. Sterile Production
13. Packaging
14. Laboratory Controls
15. Documentation
16. Research and Development
17. Contractors and Suppliers
18. Inspections
19. Quality Unit
20. Continual Improvement
21. Active Pharmaceutical Ingredients
22. Excipients
23. Medical Devices
24. Transport

GMP Regulations

A. Empty Register
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 (this
chapter is supplied on CD-ROM
and online only)
- WHO Guidelines
- Canadian Regulations
- Japanese Regulations
- Chinese Regulations
- Indian Regulations
- Australian Regulations
- Brazilian Regulations
H. Information
- GMP Abbreviations
- GMP Glossary
- Addresses
- References

>>> full table of contents
Your benefits
  • comprehensive GMP database
  • regularly updated
  • reliable GMP information written by experts
  • easy to use
  • and much more...