“In November 2025, the FDA published an updated version of the guideline, 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, more clearly structured and more closely tailored to the specific characteristics of gases” (ECA).
To read the reference follow the link, click here…Medical Gases — Current Good Manufacturing Practice Guidance for Industry – FDA
Industry professionals supporting the industry through education and collaboration.