美国药典支持清洁验证的文件

1,FDA关于清洁验证的目的: The purpose of cleaning validation is to demonstrate that a particular cleaning process will consistently clean the equipment to a predetermined limit; the samp领 and analytical test methods 首ld be scientifically sound and provide adequate scientific rationale to support the validation. 2,清洁验证的历史 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. 特价销售TOC总有机碳分析仪,Sievers 实验室型TOC分析仪 梅特勒M系列天平 特价销售TOC总有机碳分析仪,Sievers5310 实验室型TOC分析仪