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

标准号：CGA M-9-2008
中文标准名称：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
英文标准名称：Maintaining bulk gas supplier fingerprint analysis at compressed medical gas filling facilities
标准类型：G00
发布日期：2008/1/1 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：G00
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
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.