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New Releases

Qualification and Calibration of Laboratory Instruments in Pharmaproduction
A number of different approaches can be taken when it comes to the qualification of analytical instruments. But which one should you take?
This pdf download will help you mastering all phases of qualification and calibration!

incl. form for a requalification report, samples of a qualification plan and report, sample calibration SOP

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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!

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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.

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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!

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Qualification of Pharma Water Supply Systems
Step-by-step through the whole qualification process of water treatment systems including sample documents for all stages! The qualification of pharma water systems has never been so easy!

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Inspection of Process Validation
Do your validation processes meet their specified requirements?

This bilingual guide offers an excellent up-to-date approach on process validation. It facilitates the planning and execution of all necessary steps to be compliant.

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GDP Audit Questionnaire
for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical Devices

NEW: now also for active substances and modifiable!

More than 700 questions with references to GMP/GDP regulations and EN ISO 13485 on the preparation and implementation of Good Distribution Practice (GDP) audits

Your perfect working tool: compact and practice-oriented!

NEW ++ NEW ++ NEW

 
 
 
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