方案摘要
方案下载应用领域 | |
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参考标准 |
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 sampling and analytical test methods should 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 cGMP’s for the 21st century: A risk based approach.
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