FDA Relaxes 14-Year-Old Recommendations for Medical Gas GMP Compliance
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures.
The agency said it no longer intends to object if manufacturers do not comply with CFR requirements for expiration dating of designated medical gases with unique stability characteristics.
The previous version, issued in 2003, required that each container bear an expiration date, based on related storage conditions, and recommended that high-pressure cylinders stored for long periods be monitored for correct pressure and periodically verified.
According to the new draft, if a manufacturer labels a gas with an expiration date, it must be supported by stability studies, under 21 CFR 211.137. Companies may also opt not to distribute their oldest stock first — otherwise required by federal regulations — as long as they have a system in place to manage their stock in an orderly manner, the FDA said.
Additionally, the agency does not intend to object if manufacturers do not comply with requirements for using the oldest containers and closure systems first. Companies should perform prefill tests, and ensure that the containers and closures are not exposed to conditions that make them unfit for use.
The FDA also relaxed its recommendations for complying with requirements for calculating yield. The 2003 draft guidance said actual and theoretical yields had to be determined at the end of each phase of manufacturing, processing, packing and holding. The new draft says filling to a predetermined and acceptable temperature or pressure limit, along with finished product testing, is sufficient to meet product specifications.
The FDA issued a final rule for the design of medical gas containers last November, requiring that certain containers have gas-specific connections that cannot be readily removed or replaced, except by the manufacturer. The rule includes labeling, naming and color requirements — in response to incidents where incorrect containers were connected to a healthcare facility’s oxygen supply system, leading to serious injuries and deaths).