GMP Manufacturing

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

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

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

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

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

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

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

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