FDA发布医用气体CGMP指南草案，修订并取代2017年6月版本
Current Good Manufacturing Practice for Medical Gases
FDA宣布发布《医用气体——现行药品生产质量管理规范》指南草案，该草案修订并取代2017年6月发布的同名指南草案。指南旨在帮助医用气体生产商符合2025年12月18日生效的CGMP规定，组合产品CGMP要求的符合性修订于2026年2月2日生效。文件标注为2025年11月草案、非强制建议、不供实施，公众可随时提交意见，案卷号为FDA-2003-D-0431。
草案修订并取代2017年6月版本，与2025年12月18日生效的医用气体CGMP规定对应，可供行业对照提交意见。
GUIDANCE DOCUMENT
Medical Gases — Current Good Manufacturing Practice Draft Guidance for Industry November 2025
Draft
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2003-D-0431
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Veterinary Medicine
Office of Inspections and Investigations
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Medical Gases -- Current Good Manufacturing Practice.” This guidance is intended to assist manufacturers of medical gases in complying with regulations for current good manufacturing practice (CGMP) that become effective on December 18, 2025 (note, the conforming amendments to the CGMP requirements for combination products became effective February 2, 2026). These regulations are specific to medical gases for human and animal use and, like all CGMP requirements, contain the minimum requirements to ensure that manufacturing processes operate under a state of control to meet prespecified quality standards for identity, strength, quality, and purity, but are tailored more narrowly to how medical gases are manufactured, packaged, labeled, stored, and distributed. This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance entitled “Current Good Manufacturing Practice for Medical Gases” issued in June 2017.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2003-D-0431 .
来源：FDA Pharmaceutical Quality Documents · fda.gov