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12.0 Deviations: Any deviation from the protocol connected to the producing process, raw supplies, equipment applied, sampling, in-process controls and analytical methods should be authorized and documented from the batch manufacturing document and also the validation report.

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持续工艺验证涉及在商业产品生产过程中的持续验证，以确保在先前阶段设计和确认的工艺能够按照期待的那样继续提供一致的产品质量。这是一个生命周期管理（lifecycle administration）的范畴。

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Compressed air in a lot of the GMP creation processes will come into direct connection with the product, and therefore has to be determined as essential utility the variability of which has an influence on the merchandise quality and for that reason really should be monitored or controlled.

将原材料变成成品的过程的每一步。这包括在工艺的各个阶段预先定义的取样点。

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