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Production

Failure Management in a GMP Regulated Environment
How can occured failures be avoided in the future? Start to treat the root cause, not the symptoms!

Learn how to set up a failure management system and how to use root cause analysis methods and tools correctly!

NEW ++ NEW ++ NEW

 
 
EU-Compliant Batch Release of Medicinal Products
How to Meet the GMP Requirements of Annex 16 EU GMP Guide

Batch release is complex and challeging due to requirements, responsibilities and the global product flow. Make sure to safely circumvent the multiple pitfalls that lie in wait – Order now!

NEW ++ NEW ++ NEW

 
 
Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing
The draft of Annex 1 of the EU GMP Guidelines keeps numerous responsible persons in the pharmaceutical industry busy. Are you already prepared for the possible changes?
Based on a comparison with the currently valid version this download demonstrates where action is needed.

NEW ++ NEW ++ NEW

 
 
Classes and Grades for Air Cleanliness
This pdf download provides you with the tools you need to achieve compliance with the limits for airborne particles and microorganisms. Learn all you need to know about GMP requirements for cleanroom premises!

 
 
A Successful Concept for Technology Transfer in Drug Manufacturing
This download covers all aspects you have to consider when transferring!

incl. an example of a transfer plan you can directly work with

 
 
Roadmap to Manage Personnel in Pharmaceutical Manufacturing
The deployment of human resources must be carefully planned and organised. In order to assist you in successful human resource management and training, we have compiled this detailed roadmap

 
 
 
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