美國藥典支持清潔驗證的文件

1,FDA關于清潔驗證的目的: The purpose of cleaning validation is to demonstrate that a particular cleaning process will consistently clean the equipment to a predetermined limit; the samp領 and analytical test methods 首ld be scientifically sound and provide adequate scientific rationale to support the validation. 2,清潔驗證的歷史 1963 GMP Regulations: "Equipment shall be maintained in a clean and orderly manner. 1978 cGMP Regulations: Section 211.67 added describing equipment cleaning and maintenance. 1993 FDA guided to inspections for cleaning validation. 2002 Pharmaceutical cGMPs for the 21st century: A risk based approach. 特價銷售TOC總有機碳分析儀,Sievers 實驗室型TOC分析儀 梅特勒M系列天平 特價銷售TOC總有機碳分析儀,Sievers5310 實驗室型TOC分析儀