CGA M-11-2014

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Guideline for Compliance With The Quality Systems Approach to Pharmaceutical CGMPS

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 [1]. It is based on a review of the FDA’s September2006 Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations [3].

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Compressed Gas Association, Inc. [cga]

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Guideline for Compliance With The Quality Systems Approach to Pharmaceutical CGMPS

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CGA M-11-2014

Guideline for Compliance With The Quality Systems Approach to Pharmaceutical CGMPS

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