FDA publishes new Draft Guideline on GMP for Medical Gases

In November 2025, the FDA published the new draft guideline 'Medical Gases - Current Good Manufacturing Practice', thereby fundamentally revising the previous version from 2017. The draft will come into effect on 18 December 2025. Unlike the very general 2017 version, the new version is significantly more technical, clearly structured and more closely tailored to the specific characteristics of gases. According to the FDA, the aim of the revision is to reduce the regulatory burden on the industry where traditional medicinal product requirements are not appropriate. At the same time, however, aspects that are crucial for the quality, identity and purity of gases are to be clarified.

Clear definition of the scope of application

A key difference from the old version is the clear definition of the scope of application. The guideline applies exclusively to medical gases that are classified as medicinal products for humans or animals - i.e. to so-called 'designated medical gases' such as oxygen USP, nitrogen NF, carbon dioxide USP, medical air or helium. Gases that are not used as medicinal products are expressly excluded from this draft. The FDA refers here to industrial gases, technical gases and gases that are used solely as auxiliary or process gases in the manufacture of medicinal products, such as nitrogen for inerting. Calibration gases used, for example, in laboratories to adjust measuring instruments are also excluded. This clear exclusion principle was only hinted at in the 2017 version.

The new guideline also addresses numerous regulatory changes that have been made since 2017. It incorporates the amended GMP requirements for medical gases and, for the first time, contains specific guidance on how manufacturers should meet the requirements for controlled manufacturing conditions in practice. This includes the role of the quality unit, responsibility for supplier qualification, documentation and release processes. Even very small manufacturing and filling sites - such as companies that exclusively transfer medical oxygen or produce on a smaller scale using cylinders - are explicitly taken into account in the new guideline, which was hardly addressed in the old version.

Extensive expansion of the technical chapters

The technical chapters have been expanded considerably. The FDA describes how filling systems, manifolds, valves, check valves, cryogenic containers and connection systems are to be qualified, cleaned and maintained. Also new are more precise specifications for leak tests, vacuum specifications for cylinder emptying, handling of residual pressure valves, and test methods that may be used in alternative test strategies. The 2017 guideline contained only general statements on this subject, whereas the new draft version provides specific examples and minimum technical requirements.

The chapters on laboratory testing and requirements for CoAs have also been expanded compared to 2017. The FDA now describes in detail how the identity, purity, composition and strength of gases are to be tested, what data a Certificate of Analysis must contain, and how alternative test methods are to be validated.

Overall, the new draft guideline provides significantly more clarity regarding regulatory expectations for the gas industry. The scope is now clearly limited to medical gases as medicinal products, while industrial, technical and process-related gases are excluded. At the same time, the draft provides a wide range of practical recommendations for manufacturing processes, equipment, documentation, leak testing, laboratory testing and transport containers for the first time, replacing the comparatively general version from 2017.

Please visit the FDA website for the guideline 'Medical Gases - Current Good Manufacturing Practice'.