Product and process validation的意思|示意

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。

New product development is a complex process which ranges from technical and economic feasibility study, engineering development, design validation etc. till mass production.

新产品开发过程是一个复杂的过程，其中涉及到大量经验性的工程设计知识。