retrospective validation meaning in Chinese

回顾性验证

Examples

Processes in use for some time should also be validated ( retrospective validation )
使用中工艺有时也应该进行验证（回顾性验证）。
5 retrospective validation uses the data of earlier manufactures , but is not a recommended technique for aseptic processes
5回顾性验证使用以前的生产数据，无菌工艺不提倡用回顾性验证。
For retrospective validation , generally data from ten to thirty consecutive batches should be examined to assess process consistency , but fewer batches may be examined if justified
对于回顾性验证，通常要对10到30个连续批次的数据进行检查来评估工艺的一致性，如果可以证明正确性，那么也可以使用稍少的批次进行。
Retrospective validation is only acceptable for well - established processes and will be inappropriate where there have been recent changes in the composition of the product , operating procedures or equipment
回顾性验证仅适用于已经完善的工艺，对于近期在产品组成、操作程序或者设备方面有过变更的情况是不适用的。
Batches selected for retrospective validation should be representative of all batches made during the review period , including any batches that failed to meet specifications , and should be sufficient in number to demonstrate process consistency
用于回顾性验证的批次，必须在所有回顾期间生产的批次中选择具有代表性的批次，包括任何没有达到标准的批次，并且在数量上应该足以示范工艺过程的一致性。

retrospective validation meaning in Chinese

Examples

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