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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

Annex 6 EU GMP Guideline published

On Febraury 3, 2010 the European Commission published the revised Annex 6 "Manufacture of Medicinal Gases"  of the EU GMP Guideline. The Annex' deadline for comming into operation is Juliy 31, 2010.  


The Annex was revised as a consequence of the restructuring of the GMP Guide and the need to modify the requirements of Part II of the Guide for applicability to medicinal gases. There was a need to define more clearly what should be considered as a starting material as opposed to a bulk pharmaceutical product. The opportunity was also been taken to update the annex in general.


EC/ Annex 6

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