GMP Publications

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

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

incl. an example...

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

Introducing and implementing an EBR system requires systematic analysis, definition and...

The introduction of a LDMS has an extremely positive impact on the efficiency and quality of...

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

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....

A step-by-step guide based on real-world examination experience. Discover how...

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

This e-book lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and...

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

This e-book leads you step by step through the 4 key processes in microbiological...

• 1 named user
• 3-month-subscription
• €107 / US$128.40 per month
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• multiple users; one user at a time
• 3-month-subscription
• €299 /...

A helpful guide which facilitates the entry into the GMP world and teaches the necessary...

A quarterly publication which provides in-depth analyses of international pharmaceutical...

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

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

Get an quick and comprehensive overview of the complex world of Good Manufacturing Practice...

for the Transport and Storage of Medicinal Products for Human Use, Active Substances and...

For auditors and manufacturers of drugs and APIs.

More than 650 typical questions...