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技術(shù)轉(zhuǎn)移到商業(yè)化工廠的，應(yīng)當(dāng)在實(shí)際技術(shù)轉(zhuǎn)移前完成設(shè)備,、儀器的確認(rèn),。

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(yàn)證通常從研發(fā)設(shè)施開(kāi)始，或作為前瞻性驗(yàn)證(傳統(tǒng)方法),，或作為第一階段工藝驗(yàn)證(參見(jiàn)有關(guān)工藝驗(yàn)證新方法及生命周期方法的參考文獻(xiàn)),。注:工藝驗(yàn)證應(yīng)根據(jù)當(dāng)前WHO技術(shù)報(bào)告系列(3)中發(fā)布的現(xiàn)行指南進(jìn)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(yīng)在轉(zhuǎn)移方進(jìn)行適當(dāng)?shù)尿?yàn)證，并按照書(shū)面的程序移交給接收方,。應(yīng)在接收方繼續(xù)進(jìn)行確認(rèn)和驗(yàn)證,。

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