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The IPEC Europe 'How-To' Document on EU Guidelines on Risk Assessment for Excipients 2015

Origin/Publisher:

IPEC Europe, Avenue des Gaulois, 9; 1040 Brussels

Document Type:
IPEC Industry Best Practice document
Content:
This document provides guidance on how to implement a formalised risk assessment for ascertaining the appropriate GMP for excipients according to the requirements of the EU Guideline OJ 2015/C 95/02.

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