In our GMP ebooks you will find detailed information and many useful example documents for direct implementation.
Use the ebooks developed by GMP experts to deepen your specialist knowledge:
The draft of Annex 1 of the EU GMP Guidelines keeps numerous responsible persons in the...
€97.00 net
What has changed compared to the last version? Are there new requirements that did not...
€49.00 net
Step-by-step through the whole qualification process of water treatment systems including...
€117.00 net
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...
Do your validation processes meet their specified requirements? This bilingual guide offers an...
€59.00 net
A comprehensive step-by-step guide, which covers all aspects of selecting and managing...
€345.00 net
This pdf download leads you step by step through the 4 key processes in microbiological...
This pdf download lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ...
Nowadays all regulatory authorities focus on data integrity and have their own data integrity...
A step-by-step guide based on real-world examination experience. Discover how...
This pdf download is the ultimate guide to preparing your company for compliance with GDP....
A Guide to Control Microbial Risks in Sterile and Aseptic Drug Manufacturing
What is the GMP-compliant approach and what do the single steps in the process flow look like?...
€87.00 net
The introduction of a LDMS has an extremely positive impact on the efficiency and quality of...
Introducing and implementing an EBR system requires systematic analysis, definition and...
Various different aspects must be considered in order to transfer documentation management,...
This download covers all aspects you have to consider when transferring!
incl. an...
This pdf download shows how you can establish an effective CAPA system, which interfaces there...
In this pdf download you'll find answers on how deviations are defined, what must be observed...
This download shows you procedures you can implement now that ensure the successful management...
The deployment of human resources must be carefully planned and organised. In order to assist...
A qualification serves to prove that equipment is fit for its given purpose. So far, so good....
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