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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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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