• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Shopping cart
Your shopping cart is empty

Show shopping cart...
Stay informed!

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

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

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

NEW ++ NEW ++ NEW

 
 
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.

 
 
Pharma Change Control
Strategies for Successful Company-Wide Implementation

Every page offers practical strategies to implement a company-wide change control program and meet FDA regulatory requirements.

 
 
Preparing for the EU GMP Inspection
This handbook tells you what you need to know about the similarities - and subtle differences - between FDA and EU GMP inspections.

 
 
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.

 
 
Manufacturing Sterile Products to Meet EU and FDA Guidelines
This management report spells out how U.S. and EU manufacturers must handle sterile processing.

 
 
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.

NEW ++ NEW ++ NEW

 
 
The Drug Manufacturer‘s Guide to Site Master Files
Instructions for preparing a Site Master File according to
PIC/S PE 008-4

Without an up-to-date Site Master File, you are not authorized to market pharmaceuticals to European customers.

 
 
 
Page 1/1    1