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技術轉移到商業(yè)化工廠的,，應當在實際技術轉移前完成設備、儀器的確認,。

10.5. Process validation usually starts in research anddevelopment facilities either as prospective validation (traditional approach)or as stage I process validation (see references regarding the new approachesin process validation; and the life cycle approach). Note: Process validationshould be done according to current guidelines as published incurrent WHO Technical Report Series (3).

工藝驗證通常從研發(fā)設施開始,，或作為前瞻性驗證(傳統(tǒng)方法)，或作為第一階段工藝驗證(參見有關工藝驗證新方法及生命周期方法的參考文獻),。注:工藝驗證應根據(jù)當前WHO技術報告系列(3)中發(fā)布的現(xiàn)行指南進行,。

10.6. Procedures including processing and analytical procedures,should be appropriately validated at the SU and transferred to the RU followingdocumented procedures. Verification and validation, as appropriate, should becontinued at the RU as identified and documented in the technology transferprotocol.

程序，包括加工和分析程序,，應在轉移方進行適當?shù)尿炞C,，并按照書面的程序移交給接收方。應在接收方繼續(xù)進行確認和驗證,。

10.7. For cleaning procedures, development and validation shouldbe done in accordance with the guidelines as published in current WHO TechnicalReport Series