Batches made for process validation should be the same size as the intended industrial scale batches 工艺验证批次的生产规模应该与已定的工业生产批次相同。
Review the validation status of analytical methods validation , process validation and cleaning validation for products 产品的分析方法验证、工艺验证、清洁验证的验证状态的审核。
Process validation should normally be completed prior to the distribution and sale of the medicinal product ( prospective validation ) 工艺验证通常应该在医药产品分发销售(预验证)前完成。
4 concurrent validation includes a process validation with the same requirements as for prospective studies , but performed during routine production on qualified equipment 4同步验证同前验证类似,不过验证是基于在经过确认的设备上的常规生产。