(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.

对于清洁程序，开发和验证应按照当前WHO技术报告系列(6)中发布的指南进行。在建立清洁程序、可清洁能力研究并设置可接受限度时，应考虑《在清洁验证中应用HBEL(14)的考量》。

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

分析程序应根据当前WHO技术报告系列(7)中发布的准则进行验证。

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

应适当地记录确认和验证程序、方案、数据和结果。文件应按照程序规定予以保存。

11. Product life cycle and project managementprinciples

产品生命周期和项目管理原则

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.

在计划和实施转移时，应考虑转移的设施、设备、仪器、公用系统、产品、工艺或程序的生命周期的相关阶段。

Appendix 1 Example of documentation commonlyrequired for the transfer of technology