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GMP Focus - Downloads

The GMP Focus files offer an overview of different aspects of GMP subjects.
This books will prepare you for your daily business.

Available as pdf downloads – excerpts from the GMP Compliance Adviser

Data Integrity in the EU
Nowadays all regulatory authorities focus on data integrity and have their own data integrity guidelines - however, their regulations don’t always agree.
With this pdf download you will understand all the requirements! This report details the ins and outs of all three documents of EMA, MHRA and WHO and explains how the FDA regulations fit in.

 
 
Principles of Equipment Qualification
This pdf download lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and PQ - that satisfies US and EU requirements.

incl. checklists for carrying out a qualification plan and instructive diagrams

 
 
Managing Contract Manufacturers and Testing Labs
A comprehensive step-by-step guide, which covers all aspects of selecting and managing contractors.

 
 
Creating a Master Plan for Drug Warehousing, Transportation and Distribution
This pdf download is the ultimate guide to preparing your company for compliance with GDP. Step by step, it walks you through the planning and implementation process, including the six key requirements included in the EU GDP Guidelines!

 
 
A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance

This pdf download helps you bring your drug manufacturing quality systems into compliance!

The lifecycle process approach is an orderly and effective way of taming the quality system. Once you have mastered it, you will wonder why you waited.

 
 
Computer System Validation in the EU
Discover the tools you need to develop your trans-national validation program.
Use this step-by-step guide to implement a computer validation program that will satisfy U.S. and EU regulations!

 
 
Environmental and Microbiological Monitoring at Drug Manufacturing Sites
This pdf download leads you step by step through the 4 key processes in microbiological monitoring.
Additionally you will get a detailed look at monitoring and testing in 3 critical areas: surfaces, personnel and air.

 
 
Managing Process Validation
A step-by-step guide based on real-world examination experience. Discover how to document process validation in a way that is sure to satisfy — and impress — regulators!

 
 
 
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