技术转移到商业化工厂的，应当在实际技术转移前完成设备、仪器的确认。

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).

工艺验证通常从研发设施开始，或作为前瞻性验证(传统方法)，或作为第一阶段工艺验证(参见有关工艺验证新方法及生命周期方法的参考文献)。注:工艺验证应根据当前WHO技术报告系列(3)中发布的现行指南进行。

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，应在转移方进行适当的验证，并按照书面的程序移交给接收方。应在接收方继续进行确认和验证。

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