CGA M-2-2025

Standard for the Manufacture of Designated Medical Gases - 4th Edition

This publication serves as a compliance standard for manufacturers of designated medical gases classified as drugs under Title 21 of the U.S. Code of Federal Regulations (21 CFR). It outlines industry practices aligned with current good manufacturing practice (CGMP) requirements for bulk production and distribution of oxygen USP, nitrogen NF, carbon dioxide USP, helium USP, and nitrous oxide USP. While offering guidance for regulatory adherence, it emphasizes that manufacturers are responsible for ensuring their standard operating procedures meet all applicable federal, state, and local regulations. The scope excludes:gases that may be approved via a new drug application (NDA) or abbreviated new drug application (ANDA); gases that are subject to an Investigational New Drug Application, e.g., a gas or gas mixture that has never been previously used as a drug, NDAs, or ANDAs by the Act; or gases classified by FDA as medical devices as defined by the Act .This publication does not specifically address refrigerated liquid oxygen USP that is filled at a patient’s residence or is filled, repackaged, transfilled, and/or relabeled by home respiratory care companies as this filling activity may utilize alternate compliance methods. This publication only contains information on industry practices that is used to ensure compliance with the FDA requirements. The practices for the fabrication, packaging/labelling and testing of medical gases for firms operating in Canada shall comply with the general interpretation of the Health Canada guidance document GUI-0031, Good Manufacturing Practices (GMP) for Medical Gases