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文献详情 >医疗保健产品的无菌处理 第1部分:一般要求 收藏
医疗保健产品的无菌处理 第1部分:一般要求

医疗保健产品的无菌处理 第1部分:一般要求

Aseptic processing of health care products. Part 1:General requirements second edition

标准编号:ISO 13408-1-2008

发布日期:1900年

实施日期:20080615

页      码:54页

学科分类:0303[法学-社会学类] 

主      题:无菌的 检验 定义 医疗卫生事业 制造 Aseptic Checks Definitions Health services Manufacturing Medical technology Production Quality Quality assurance Specification (approval) Sterility 

中国标准分类号:C;C47

国际标准分类号:11;11.080.01

摘      要:1.1 This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes,programmes and procedures for development, validation and routine control of the manufacturing process foraseptically-processed health care products.1.2 This part of ISO 13408 includes requirements and guidance relative to the overall topic of asepticprocessing. Specific requirements and guidance on various specialized processes and methods related tofiltration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems aregiven in other parts of ISO 13408.NOTE This part of ISO 13408 does not supersede or replace national regulatory requirements, such as GoodManufacturing Practices (GMPs) and/or pharmacopoeial requirements that pertain in particular national or regionaljurisdictions.

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