CGA M-9-2008
对压缩医用气体填充设施的大量气体供应商指纹分析进行维护

Maintaining bulk gas supplier fingerprint analysis at compressed medical gas filling facilities


 

 

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标准号
CGA M-9-2008
发布日期
2008年01月01日
实施日期
废止日期
中国标准分类号
G00
发布单位
US-CGA
引用标准
CGA M-7 United States Pharmacopeia and National Formulary, United States Pharmacopeia, 12601 Twinbrook Pkwy, Rockville, MD 20852. www.usp.org
代替标准
CGA M-9-2015
适用范围
This publication provides criteria that medical gas transfill companies can use to satisfy FDA's fingerprinting concerns. It applies to the procurement of bulk medical gas by transfill companies and the requirement that bulk carbon dioxide suppliers provide appropriate certification regarding their product's compliance to current good manufacturing practices (CGMP) and USP specifications.




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