Medical gases are regulated as pharmaceutical finished products by the FDA and must meet certain GMP requirements (21 CFR 210 and 211) regardless of their production stage. This guidance is intended to assist manufacturers of medical gases in meeting those. According to the FDA the guideline aims at reducing the regulatory compliance burden by providing clear, up-to-date, detailed recommendations regarding CGMP issues that have been the subject of industry questions. Compared to the previous version the text volume has been reduced significantly from 45 to 28 pages.
The following GMP requirements for medical gases are included:
Comments and suggestions can be submitted within 60 days of publication. For more details please refer to the FDA draft guidance.