Publication Details

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


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.