Rx-360 Flash Report
A Nonprofit Organization
www.Rx-360.org

The European Commission recently published draft revisions to both Chapters 5 and 7 of the EU GMP Guide,  titled “Production” and “Outsourced Activities” respectively.   Revisions to both address optimization of control over the supply chain and contractors.  We will provide a summary of the Chapter 5 draft revisions in the near future.  Revisions to Chapter 7 include expansion of scope from Contract Manufacture and Analysis to Outsourced Activities, thus including many more functions than addressed in the current version.  Consistent with changes made to other Chapters and Annexes of the EU GMP Guide that have been recently revised, the concepts of Quality Systems (ICHQ10) and Risk Management (ICHQ9) have been incorporated.   Comments on the draft revisions, if companies are interested, are due February 28, 2010. 

To view or download the EU Draft Revisions, click here

To view or download the Rx-360 Summary, click here

Rx-360 | An International Supply Chain Organization - Washington D.C. - info@rx-360.org
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