人妻秘书ol中文字幕星空传媒影视公司|中文字幕人妻中文字幕成人性电影|国产精品美女久久久久久免费亚洲国产精品中文字幕一区久久|中文字幕在线天堂中文字幕一区一区二区三区|91丨九色丨国产熟女a|亚洲国产精品91|91极品国产|色悠悠国产精品|亚洲av一线二线久久性色|9区中文字幕在线,999中文字幕精品,成人久久不卡一区二区三区,国产av专区网站大全

應(yīng)針對(duì)待轉(zhuǎn)移的工藝,、產(chǎn)品或程序?qū)嵤┡嘤?xùn)計(jì)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(xiàng)目過程中所作的任何變更和調(diào)整都應(yīng)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(shù)轉(zhuǎn)移項(xiàng)目的執(zhí)行情況應(yīng)記錄在一份報(bào)告中,，并有相關(guān)數(shù)據(jù)支持。

5.12. Data should meet ALCOA+ principles.

數(shù)據(jù)應(yīng)符合ALCOA+原則,。

6. Quality management and quality riskmanagement

質(zhì)量管理和質(zhì)量風(fēng)險(xiǎn)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(yīng)該有一個(gè)適當(dāng)設(shè)計(jì),、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(yīng)有足夠的資源,，充分實(shí)施和維護(hù),。

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(yīng)包含GxP，應(yīng)應(yīng)用于產(chǎn)品和工藝生命周期的各個(gè)階段,，包括技術(shù)轉(zhuǎn)移,。

6.4. The quality system should ensure that:

質(zhì)量體系應(yīng)確保：

• responsibilities are clearly specified inwriting;

• 職責(zé)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(gè)質(zhì)量風(fēng)險(xiǎn)管理系統(tǒng)

• arrangements are made for the documentedtechnology transfer.

• 已就書面的技術(shù)轉(zhuǎn)移作出安排。