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.

While the FDA’s Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations does not contain regulatory requirements, it represents the FDA’s latest thinking on quality systems and provides recommendations for compliance with the CGMP regulations. Companies shall refer to 21 CFR to ensure they are in full compliance with the regulations. The guidance is also aligned with the medical devices quality system’s regulations (21 CFR Part 820).

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.