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本帖最后由 清歌一曲月如霜 于 2014-1-28 17:40 编辑
6. Is it generally acceptable from a cGMP perspective for a manufacturer of sterile drug products produced by aseptic processing to rely solely on ISO 14644-1 and ISO 14644-2 when qualifying their facility?
No. It is generally not acceptable from a current good manufacturing practice (“cGMP”) perspective for a manufacturer of sterile drug products produced by aseptic processing to rely solely on ISO 14644-1 Part 1: Classification of Air Cleanliness (“14644-1”) and ISO 14644-2 Part 2: Specifications for Testing and Monitoring to Prove Compliance with ISO 14644-1 (“14644-2”) when qualifying their facility. Rather, a manufacturer of sterile drug products produced by aseptic processing should use these ISO standards in combination with applicable FDA regulations, guidance and other relevant references to ensure a pharmaceutical facility is under an appropriate state of control. Consequently, appropriate measures augmenting ISO’s recommendations (e.g., with microbiological data) would likely be expected for a firm to meet or exceed CGMP in a pharmaceutical facility.
Please understand that 14644-1 and 14644-2 have superseded Federal Standard 209E, Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones (“Federal Standard 209E”). In November 2001, the U.S. General Services Administration canceled Federal Standard 209E.
While not FDA regulations or FDA guidance, the Agency believes 14644-1 and 14644-2 are useful in facilitating the international harmonization of industrial air classification for non-viable particle cleanliness in multiple industries (e.g., computer, aerospace, pharmaceutical). As such, FDA adopted these particle cleanliness ratings in the 2004 guidance for industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice. However, due to the unique aspects of producing sterile drug products by aseptic processing (e.g., microbiological issues) an aseptic processing manufacturer should not rely solely on 14644-1 and 14644-2 when qualifying their facility.
References:
•U.S. Food and Drug Administration website.
•International Organization for Standardization website.
•ISO 14644-1 Part 1: Classification of Air Cleanliness.
•ISO 14644-2 Part 2: Specifications for Testing and Monitoring to Prove Compliance with ISO 14644-1.
•Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice (2004).
•Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals (Title 21, Code of Federal Regulations, Part 211).
谷歌翻译：
它是从一个角度的cGMP对无菌药品制造商通过无菌加工制作单纯依靠ISO 14644-1和ISO 14644-2预选赛他们的设备时，一般可以接受？
不，它一般不接受从现行良好生产规范（ “ cGMP的” ）的角度对无菌药品制造商通过无菌加工制作单纯依靠ISO 14644-1第1部分：空气洁净度（ “ 14644-1的分类“ ）和ISO 14644-2第2部分：规范测试和监控，以证明符合ISO 14644-1 （「合资格的机构时14644-2 ” ） 。相反，用无菌工艺生产的无菌药品制造商应该使用这些ISO标准与适用的FDA法规，指导及其他相关文献相结合，以确保药品的设施是控制一个合适的状态下。因此，适当的措施，充实国际标准化组织的建议（例如，与微生物数据）很可能会预期一个公司达到或超过CGMP的制药设备。
请理解14644-1和14644-2已经取代美国联邦标准209E ，在洁净室和洁净区（ “联邦标准209E ” ）大气颗粒清洁度等级。 2001年11月，美国总务管理局取消了联邦标准209E 。
虽然没有FDA法规或FDA的指导，该机构认为14644-1和14644-2是促进工业空气分级非可行粒子洁净多个行业（如计算机，航空航天，医药）的国际协调有用。现行良好生产规范 - 因此，美国FDA在2004年的行业指南无菌制剂产品通过无菌工艺生产采用这些微粒洁净度等级。但是，由于无菌处理（例如，微生物问题）生产无菌药品的独特方面无菌生产制造商不应仅仅依靠14644-1和14644-2排位赛他们的设备时。
参考文献：
•美国食品药品监督管理局网站。
•国际标准化组织的网站。
• ISO 14644-1第1部分：空气洁净度分级。
• ISO 14644-2第2部分：规范测试和监控，以证明符合ISO 14644-1 。
•行业指南：用无菌工艺生产无菌药品产品 - 现行良好生产规范（ 2004年）。
•现行良好制造规范（cGMP ）的成药（标题21 ，联邦法规211部分的代码） 。
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