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TOP 5 GMP Downloads

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


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


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


4. A Pharma Guide to Cleaning Validation
How to meet Agency Expectations and Establish Accepted Limits.


5. Data Integrity in the EU
Requirements for Quality Management Systems.


>>> 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 Compliance Adviser.

With the GMP Compliance Adviser, 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 Compliance Adviser

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. Empty Chapter
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

 

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 Compliance Adviser
An Overview of your Advantages - Compliance Adviser.pdf