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GMP Subject Downloads

Subject matter downloads provide instant support on hot topics in the GMP field
(Good Manufacturing Practices).

These compilations of excerpts from the GMP MANUAL offer straightforward GMP information:

GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

More than 700 questions with references to regulations for preparing and carrying out GDP audits

 
 
Premises
Official requirements | material flow | personnel flow and layout | room classes | construction elements | barrier systems and isolators | and much more...

 
 
GMP Audit Checklist
for Pharmaceutical and API Manufacturers

Checklist with more than 700 questions typically asked during GMP audits or inspections, arranged by subject-matter

 
 
Documenting 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.

 
 
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.

 
 
The Process of Freeze-Drying
How is freeze-drying performed and what are the relevant process parameters to be measured?

NEW ++ NEW ++ NEW

 
 
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.

 
 
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

 
 
 
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