retrospective validation 中文意思是什麼

retrospective validation 解釋
回顧性驗證
  • retrospective : adj. 1. 回顧的，懷舊的；愛追溯既往的。2. 【法律】有追溯力的。adv. -ly
  • validation : （有效性）驗證
  1. 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

    用於回顧性驗證的批次，必須在所有回顧期間生產的批次中選擇具有代表性的批次，包括任何沒有達到標準的批次，並且在數量上應該足以示範工藝過程的一致性。
  2. The extent of validation necessary will depend on a number of factors including the use to which the system is to be put, whether the validation is to be prospective or retrospective and whether or not novel elements are incorporated

    計算機系統驗證的范圍將根據一系列的因素來決定，包括在哪一個系統中使用的計算機，是否進行展望性驗證還是回顧性驗證，是否要將一些未知因素包含進計算機系統的驗證等。
  3. Processes in use for some time should also be validated ( retrospective validation )

    使用中工藝有時也應該進行驗證（回顧性驗證） 。
  4. 5 retrospective validation uses the data of earlier manufactures, but is not a recommended technique for aseptic processes

    5回顧性驗證使用以前的生產數據，無菌工藝不提倡用回顧性驗證。
  5. 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

    對于回顧性驗證，通常要對10到30個連續批次的數據進行檢查來評估工藝的一致性，如果可以證明正確性，那麼也可以使用稍少的批次進行。
  6. 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

    回顧性驗證僅適用於已經完善的工藝，對于近期在產品組成、操作程序或者設備方面有過變更的情況是不適用的。
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