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Miscellaneous

The Drug Manufacturer‘s Guide to Site Master Files
Instructions for preparing a Site Master File according to
PIC/S PE 008-4

Without an up-to-date Site Master File, you are not authorized to market pharmaceuticals to European customers.

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

Each question with reference to the current EU GMP Guide Part I/II and the 21 CFRs 210/211/11.

For auditors and manufacturers of drugs and APIs.

NEW ++ NEW ++ NEW

 
 
GMP Glossary and Abbreviations
GMP Pocket Guide Volume 3
Do you want to communicate clearly when it comes to GMP? Then use our GMP Pocket Guide.

 
 
 
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