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Compliance with the Quality Systems Approach to Pharmaceutical CGMPs Guidance, Second Edition
Handbook / Manual / Guide by Compressed Gas Association, 07/01/2014

Description

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.