Reference is made furthermore to the 3-step - process (process design, process qualification and continued process verification).
这里引用了3段式(工艺设计、工艺确认和持续工艺确认)。
Process qualification and continued process verification should in anycase always be linked to process design and the batches used for bioequivalencetesting.
不论什么情况下,工艺确认和持续工艺确认应总是与工艺设计相链接,与用于生物等效性测试的批次相比较。
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