GMP Manufacturing

Correctly Implementing GMP and GDP Requirements

Current regulatory requirements and...

SOP "GMP-Questionnaire: Contract Manufacturing / Contract Analysis"
Standard draft to adapt...

How to Meet the GMP Requirements of Annex 16 EU GMP Guide Batch release is complex and...

How can occured failures be avoided in the future? Start to treat the root cause, not the...

This download shows you procedures you can implement now that ensure the successful management...

A Guide to Control Microbial Risks in Sterile and Aseptic Drug Manufacturing

This pdf download leads you step by step through the 4 key processes in microbiological...

A comprehensive step-by-step guide, which covers all aspects of selecting and managing...

The draft of Annex 1 of the EU GMP Guidelines keeps numerous responsible persons in the...