Publication

M-11: Guideline for Compliance with the Quality Systems Approach to Current Good Manufacturing Practices

Abstract

This publication is intended to help manufacturers implement modern quality systems and risk management processes and to incorporate quality by design principles that meet the current good manufacturing practices (CGMP) requirements in Title 21 of the U.S. Code of Federal Regulations (21 CFR) Parts 210, 211, 820. An effective quality system helps to ensure compliance to guidance and regulation.

This publication provides guidance on how a medical gas, device gases, and device manufacturers can implement the quality systems approach to meet requirements of 21 CFR Parts 210, 211, and 820.

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Properties

Edition:

Published:

March 2021

Status:

Available To the Public

Size:

8 pages

Publisher:

CGA

Special Attributes:

Notes:

Committee:

Medical Gases

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M-11: Guideline for Compliance with the Quality Systems Approach to Current Good Manufacturing Practices

Abstract

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