DETAILED NOTES ON CLEANING VALIDATION PROTOCOL

Detailed Notes on cleaning validation protocol

Detailed Notes on cleaning validation protocol

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工艺验证是一个循序渐进的过程,旨在确保制造工艺能够始终如一地生产出优质产品。它由制药行业制造商的质量保证负责人领导的验证团队执行。尽管严格意义上的工艺验证包括工艺设计的阶段,但在实际操作中,工艺验证通常是在发布新产品之前进行的。在开始时建立的工艺验证协议(validation protocol)应明确规定如何执行验证过程,包括要监控的参数、要采集的样本和接受的结果标准。需要注意的是,在商业化生产之前,制造商应该确认产品能够满足所需的质量标准,并且设计的生产工艺满足安全性和有效性相关的要求。

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The acceptance standards with the cleaning validation will probably be pointed out in the particular protocol and can come to a decision dependant on the product matrix.

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