CGA M-11

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CGA M-11 English Secure PDF Compliance with the Quality Systems Approach to Pharmaceutical CGMPs Guidance, First Edition

Handbook / Manual / Guide published 01/31/2008 by Compressed Gas Association

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This publication provides guidance on how a medical gas manufacturer can implement the quality systems approach to meet requirements of 21 CFR Parts 210 and 211. It is based on a review of the FDA's September 2006 Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations.