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cGMP/ GMP PDF Downloads - current Good Manufacturing Practice
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GMP Subject Downloads

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

 
 
Computer System Validation in the EU
A step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations

 
 
GMP Compliant Documentation
How to create, organize, review and archive GMP related documents in pharmaceutical industries

 
 
Medical Devices
GMP requirements for medical devices

 
 
 
Pharmaceutical Water
In this ebook you'll get information about the different types of pharmaceutical water and what they are used for in pharmaceutical production.

 
 
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.

 
 
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.

 
 
 
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