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TOP 5 GMP Downloads

1. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.

 

2. Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.

 

3. GDP Audit Checklist
More than 700 questions with reference to regulations.

 

4. The New USP <1231>: Water for Pharmaceutical Purposes
A detailed overview

 

5. GMP Compliance Basics of Packaging Materials and Processes
Are you on top of the best practices you need to design and create your packaging correctly — every time?

 

>>> More Downloads

Our GMP Expertise for Your Safety

You are responsible for Good Manufacturing Practice (GMP).
We provide the essential information you need:

  • All relevant requirements up to date and clearly presented
  • GMP expert knowledge to base your decisions
  • Practical implementation support
  • Safety for your daily routine

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

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, checklists, templates and SOP examples are included.
  • GMP Regulations contain important, continuously updated GMP regulations from Europe, USA, Japan, PIC/S, ICH, WHO and more.

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. 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

 

Information

- Update history
- GMP Abbreviations
- GMP Glossary
- Contributors

Your benefits
  • comprehensive GMP database
  • regularly updated
  • reliable GMP information written by experts
  • easy to use
  • and much more...
>>> MORE INFORMATION: GMP MANUAL