Accurately scaling down to mimic manufacturing processes is essential in several aspects of process validation.

精确的规模缩小到模拟生产工艺在工艺验证中若干方面都是必不可少的。

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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。

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Process validation is the documented evidence that a process is capable of consistently delivering quality product. The manufacturing process should be understood well before process validation.

工艺验证是确证生产工艺是否可连续生产出符合质量标准要求的产品的研究过程，进行工艺验证前，应通过详细的工艺研究对工艺有充分的理解。

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