... 安装验证过程 IVP ; installation verification procedure 产品和过程验证 Product and process validation 讯保证验证与认证过程 NIACAP ...
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Product Validation Complete 产品验证完成 Product and process validation 产品和过程验证 ; 产品和过程确认 ; 程确认 ; 产品工艺有效性验证 Process and Product Validation 制程和产品检证 ..
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...tion Complete 产品验证完成 Product and process validation 产品和过程验证 ; 产品和过程确认 ; 程确认 ; 产品工艺有效性验证 Process and Product Validation 制程和产品检证 ..
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Process and Product Validation 制程和产品检证
In the following sections, we describe general considerations for process validation, the recommended stages of process validation, and specific activities for each stage in the product lifecycle.
在下述部分中，我们对工艺验证的总体考虑、建议的工艺验证和产品生命周期内每一阶段的特殊活动进行说明。
The manufacturer may obtain assurance that a product is of Pharmacopoeia quality from data derived, for example, from validation studies of the manufacturing process and from in-process controls.
生产厂商可以从数据的来源上获得产品符合药典质量的保证，如来源于生产工艺验证研究的数据以及中控的数据。
In cases where conformance to specifications cannot be adequately measured by in-process or finished product testing and inspection, the system should include validation of processes.
当最终产品的指标符合不能适当地在流程内或终测时检测，体系也要包括工艺过程验证。
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