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(6). Points to consider when using HBEL in cleaning validation (14) should be taken into account in establishing cleaning procedures,cleanability studies and setting acceptance limits.

對于清潔程序,，開發(fā)和驗證應(yīng)按照當(dāng)前WHO技術(shù)報告系列(6)中發(fā)布的指南進(jìn)行,。在建立清潔程序、可清潔能力研究并設(shè)置可接受限度時，應(yīng)考慮《在清潔驗證中應(yīng)用HBEL(14)的考量》,。

10.8. Analytical procedures should be validated according to theguidelines as published in current WHO Technical Report Series (7).

分析程序應(yīng)根據(jù)當(dāng)前WHO技術(shù)報告系列(7)中發(fā)布的準(zhǔn)則進(jìn)行驗證,。

10.9. Qualification and validation procedures, protocols, data andresults should be appropriately recorded. The documents should be retained asdefined in procedures.

應(yīng)適當(dāng)?shù)赜涗洿_認(rèn)和驗證程序、方案,、數(shù)據(jù)和結(jié)果,。文件應(yīng)按照程序規(guī)定予以保存,。

11. Product life cycle and project managementprinciples

產(chǎn)品生命周期和項目管理原則

11.1. The relevant stage of the life cycle of the facility,equipment, instrument, utility, product, process or procedure to be transferredshould be taken into consideration when the transfer is planned and executed.

在計劃和實施轉(zhuǎn)移時,，應(yīng)考慮轉(zhuǎn)移的設(shè)施、設(shè)備,、儀器,、公用系統(tǒng)、產(chǎn)品,、工藝或程序的生命周期的相關(guān)階段,。

Appendix 1 Example of documentation commonlyrequired for the transfer of technology