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GMP Inspections in Europe: Proven Strategies on How to Prepare

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TOP 5 GMP Downloads

1. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.


2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.


3. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.


4. Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to preparing a company for compliance with Good Distribution Practice (GDP).


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


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News about GMP/cGMP

Revised Chapter 4 EU GMP Guide published

On January 12, 2011 the European Commission published the revised Chapter 4 "Documentation" of the EU GMP Guide. The document will come into operation on June 30, 2011.


The revised document replaces the version of 2004. The revision has become necessary because of the increasing use of electronic documents within the GMP environment.

The changes focus mainly the sections on "Generation and Control of Documentation" and "Retention of Documents".


Read the revised chapter 4. The document will come into operation on June 30, 2011.


EC/ Chapter 4

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