GMP Publications

GMP-Conform Sampling and Handling of Substances

• regulatory requirements
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Why are Environmental Risk Assessments necessary? What evaluation phases and methods do exist?...

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

Correctly Implementing GMP and GDP Requirements

Current regulatory requirements...

Regulatory requirements for transport and storage of...

GMP knowledge for the planning, qualification and...

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

Do you already know how to proceed after having obtained an...

Are you not quite sure what an elemental impurities risk...

Are you not quite sure what a PDE report looks like and would like to take a look inside? Get...

Are you not quite sure what an OEL categorisation looks like and would like to take a look...

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

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

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

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

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

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...

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

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

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

The deployment of human resources must be carefully planned and organised. In order to assist...

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

In this e-book you'll find answers on how deviations are defined, what must be observed in...