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應針對待轉(zhuǎn)移的工藝,、產(chǎn)品或程序?qū)嵤┡嘤栍媱潯?/span>

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(diào)整都應形成充分的文件,，并經(jīng)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(zhuǎn)移項目的執(zhí)行情況應記錄在一份報告中,，并有相關數(shù)據(jù)支持,。

5.12. Data should meet ALCOA+ principles.

數(shù)據(jù)應符合ALCOA+原則。

6. Quality management and quality riskmanagement

質(zhì)量管理和質(zhì)量風險管理

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

轉(zhuǎn)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(zhì)量體系,。

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

質(zhì)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(zhì)量體系應包含GxP,，應應用于產(chǎn)品和工藝生命周期的各個階段，包括技術轉(zhuǎn)移,。

6.4. The quality system should ensure that:

質(zhì)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(zhì)量風險管理系統(tǒng)

• arrangements are made for the documentedtechnology transfer.

• 已就書面的技術轉(zhuǎn)移作出安排,。