GMP Manufacturing

Correctly Implementing GMP and GDP Requirements

Current regulatory requirements...

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

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...

This e-book shows you procedures you can implement now that ensure the successful management...

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

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

This e-book leads you step by step through the 4 key processes in microbiological...

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