GMP Knowledge

A step-by-step guide to bring your drug manufacturing systems into compliance!

Correctly Implementing GMP and GDP Requirements

Current regulatory requirements...

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

Do your validation processes meet their specified requirements? This bilingual guide offers an...

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

A number of different approaches can be taken when it comes to the qualification of analytical...

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

Step-by-step through the whole qualification process of water treatment systems including...

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

What has changed compared to the last version? Are there new requirements that did not...

This e-book covers all aspects you have to consider when transferring!

incl. an example...

What is the GMP-compliant approach and what do the single steps in the process flow look like?...

Nowadays all regulatory authorities focus on data integrity and have their own data integrity...

This SOP helps you to create and describe contracts correctly.
Standard draft to adapt and...

Ask your supplier the right questions - this questionnaire will help you!
Standard draft to...

A qualification serves to prove that equipment is fit for its given purpose. So far, so good....

This e-book shows how you can establish an effective CAPA system, which interfaces there are...

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

This e-book is the ultimate guide to preparing your company for compliance with GDP....

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

This sample document defines framework conditions and processes between contract givers and...

Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP...

Various different aspects must be considered in order to transfer documentation management,...