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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

New Part III EU GMP published (EC)

On Feburary 7, 2011 the European Commission (EC) published the new Part III "GMP related Documents" of the EU GMP Guide.


The EC adopted the Rules for establishing a Site Master File developed by the PIC/S.

The EC's notes are intended to provide guidance on the recommended content of a Site Master File. A requirement for a Site Master File is is referred to in Chapter 4 of the GMP Guide.


You can download the new Part III  "GMP related Documents" here. This document will be part of the next update of the GMP MANUAL (May 2011).


EC/ EU GMP Guide Part III

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