In our GMP shop menu we offer you two sortings of our products:according to GMP Publications or GMP SubjectsIf you are looking for help on a specific GMP subject- e.g. qualification - use this menu. Here you will find an overview of the various publications on this topic.
Sorting by GMP Publications is helpful if you already know products from GMP Publishing - e.g. a "GMP Focus" and another volume from this series or a similar product of this kind.
For auditors and manufacturers of drugs and APIs.
More than 650 typical questions...
€219.00 net
for the Transport and Storage of Medicinal Products for Human Use, Active Substances and...
This handbook is a practical and easy to read guideline, giving you a quick and comprehensive...
€34.90 net
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
This pdf download leads you step by step through the 4 key processes in microbiological...
€345.00 net
This pdf download lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ...
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....
€117.00 net
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...
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...
A qualification serves to prove that equipment is fit for its given purpose. So far, so good....
Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP...
SOP "GMP-Questionnaire: Contract Manufacturing / Contract Analysis"Standard draft to adapt...
Nowadays all regulatory authorities focus on data integrity and have their own data integrity...
How to Find and Fix ProblemsA FDAnews publication
€147.50 net
Step-by-step through the whole qualification process of water treatment systems including...
Do your validation processes meet their specified requirements? This bilingual guide offers an...
€59.00 net
This sample document defines framework conditions and processes between contract givers and...
This download shows you procedures you can implement now that ensure the successful management...
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