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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
Excerpt from the GMP Compliance Adviser

Requirements for Quality Management Systems - learn more about the principles of data integrity, systems to monitor data integrity and the storage and archiving of records.

NEW ++ NEW ++ NEW

 
 
Principles of Equipment Qualification
Excerpt from the GMP Compliance Adviser

A Guide for Drug and Device Manufacturers - learn more about the four phases of qualification.

 
 
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
Guide to prepare a company for compliance with Good Distribution Practice (GDP)

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

This ebook walks you step by step through the processes and procedures you’ll need to put in place. You’ll learn how to restructure your quality systems to satisfy GMP.

 
 
Computer System Validation in the EU
Just when you think you’ve got the FDA’s requirements figured out, the EU issues its own. Do you know how they differ? Here you'll find a step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations.

 
 
Environmental and Microbiological Monitoring at Drug Manufacturing Sites
This report provides everything you need to know to successfully monitor, investigate and mitigate contamination risks at drug manufacturing plants.

 
 
Managing Process Validation
A Drugmaker‘s Guide

Here’s a step-by-step manual based on real-world examination experience. You’ll discover how to document process validation in a way that’s sure to satisfy — and impress — regulators.

 
 
 
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