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應針對待轉移的工藝、產品或程序實施培訓計劃。

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

在項目過程中所作的任何變更和調整都應形成充分的文件，并經雙方同意。

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

技術轉移項目的執(zhí)行情況應記錄在一份報告中，并有相關數據支持。

5.12. Data should meet ALCOA+ principles.

數據應符合ALCOA+原則。

6. Quality management and quality riskmanagement

質量管理和質量風險管理

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

轉移方和接收方都應該有一個適當設計、明確定義和書面的質量體系。

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

質量體系應有足夠的資源，充分實施和維護。

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

質量體系應包含GxP，應應用于產品和工藝生命周期的各個階段，包括技術轉移。

6.4. The quality system should ensure that:

質量體系應確保：

• responsibilities are clearly specified inwriting;

• 職責有明確的書面規(guī)定

• operations are clearly defined in writing;

• 操作有明確的書面定義;

• there is a system for quality riskmanagement; and

• 有一個質量風險管理系統(tǒng)

• arrangements are made for the documentedtechnology transfer.

• 已就書面的技術轉移作出安排。