USA – Current Good Manufacturing Practice for Medical Gases Guidance for Industry

This guidance is intended to assist manufacturers of medical gases in complying with applicable current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211). Medical gases are generally regulated as finished pharmaceuticals and are subject to CGMP requirements regardless of the processing stage. Compliance with applicable CGMP requirements helps to ensure the safety, identity, strength, quality, and purity of medical gases. Medical gases that are not manufactured, processed, packed, or held according to applicable CGMP requirements can
cause serious injury or death.

24 Pursuant to its review of Federal drug regulations under the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA determined, in part, that additional guidance regarding the application of certain regulations to medical gases would be useful. This document provides such additional guidance regarding CGMP regulations. This guidance is expected to reduce the regulatory compliance burden for the medical gas industry by providing…