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 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.