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USP纯化水系统验证

Validating USP purified water system
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摘要 本文描述了如何对USP纯化水系统进行验证,包括安装确认、运行确认和性能确认。 This paper described how to validate USP purified water system including IQ,OQ and PQ.
作者 刘永太
出处 《齐鲁药事》 2005年第8期502-504,共3页 qilu pharmaceutical affairs
关键词 USP纯化水 验证 安装确认 运行确认 性能确认 USP purified water validation IQ OQ PQ
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参考文献4

  • 1ISPE, the International Society for Pharmaceutical Engineering,Pharmaceutical Engineering Guides for New and Renovated Facilities, Volume 5 ; Commi~ioning and Qualification.
  • 2ISPE, the International Society for Pharmaceutical Engineering,Pharmaceutical Engineering Guides for New and Renovated Facilities, Appendix, Volume 4; Water and Steam Systems.
  • 3The United States Pharmacopoeia XXVII.
  • 4FDA Guide to Inspections of High Purity Water Systems.

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