应针对待转移的工艺、产品或程序实施培训计划。

5.10. Any changes and adaptations made during the course of theproject should be fully documented and agreed to by both parties.

在项目过程中所作的任何变更和调整都应形成充分的文件，并经双方同意。

5.11. The execution of the technology transfer project should bedocumented in a report which is supported by the relevant data.

技术转移项目的执行情况应记录在一份报告中，并有相关数据支持。

5.12. Data should meet ALCOA+ principles.

数据应符合ALCOA+原则。

6. Quality management and quality riskmanagement

质量管理和质量风险管理

6.1. The SU and RU should each have an appropriately designed,clearly defined and documented quality system.

转移方和接收方都应该有一个适当设计、明确定义和书面的质量体系。

6.2. The quality system should be adequately resourced,implemented and maintained.

质量体系应有足够的资源，充分实施和维护。

6.3. The quality system should incorporate GxP which should beapplied to the life cycle stages of the products and processes, including thetechnology transfer.

质量体系应包含GxP，应应用于产品和工艺生命周期的各个阶段，包括技术转移。

6.4. The quality system should ensure that:

质量体系应确保：

• responsibilities are clearly specified inwriting;

• 职责有明确的书面规定

• operations are clearly defined in writing;

• 操作有明确的书面定义;

• there is a system for quality riskmanagement; and

• 有一个质量风险管理系统

• arrangements are made for the documentedtechnology transfer.

• 已就书面的技术转移作出安排。