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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.

 

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5. A Process Approach to Pharmaceutical Quality Systems
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News about GMP/cGMP

FDA: New, revised and withdrawn CDER Guidances

FDAs Center for Drug Evaluation and Reseach (CDER) regularly publishes a list of new, revised and wihtdrawn guidances.

 

The most recent catalog shows the changes from January until May 2011.

Outcome:

Please find the document on the FDA Website.

Source:

FDA/ List of Guidance Documents

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