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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.

 
 
GMP Audit Checklist
for Pharmaceutical and API Manufacturers

Checklist with more than 700 questions typically asked during GMP audits or inspections, arranged by subject-matter

 
 
GMP Glossary and Abbreviations
GMP Pocket Guide Volume 3
Definitions of GMP terms – easily explained.

THE reference book of GMP terminology for newcomers and experts!

 
 
GMP for APIs
GMP Pocket Guide Volume 1
ICH Q7 combined with APIC/Cefic "How to do" Document

The ICH Q7 is the most important GMP guideline for active pharmaceutical ingredients manufacturers worldwide.

 
 
 
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