参考文献

Further reading

拓展阅读

Abbreviations

缩略语

Appendix 1. Example of documentation commonly required for the transferof technology

附录1. 技术转移通常需要的文件示例

Appendix 2. Example of possible experimental designs and acceptancecriteria for analytical testing

附录2. 分析测试可能的实验设计和接受标准示例

4. Due diligenceand gap assessments

尽职调查和差距评估

4.1.         A process of duediligence, gap assessment or audits of the SU and RU should be one of the firststeps when considering a technology transfer project.

在考虑技术转移项目时，首先应对转移方和接收方进行尽职调查、差距评估或审计。

4.2. The suitability and degree of preparedness of the RU should beassessed prior to the start of the transfer. The procedure to be followedshould be documented.

接收方的适当性和准备程度应在转移开始之前进行评估。应将应遵循的程序形成文件。

4.3. The assessment should be done by a team of appropriately qualifiedpersons with knowledge and experience in the field of GxP and the activity tobe transferred.

评估应由一个具有GxP领域知识和经验的适当资质的人员组成的团队来完成。

4.4. The assessment should further cover resources including personnel,premises, equipment and instruments, utilities, QC, documentation, computerizedsystems, qualification and validation and waste management.