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轉(zhuǎn)移方應(yīng)提供與所轉(zhuǎn)移的工藝,、產(chǎn)品或程序有關(guān)的必要文件,。

5.5. The SU should provide criteria and information on inherentrisks, hazards and critical steps associated with the process, product orprocedure to be transferred. This may serve as a basis for the risk assessmentexercise.

轉(zhuǎn)移方應(yīng)提供與所轉(zhuǎn)移的工藝、產(chǎn)品或程序相關(guān)的固有風(fēng)險(xiǎn),、危害和關(guān)鍵步驟的標(biāo)準(zhǔn)和信息,。這可作為風(fēng)險(xiǎn)評估工作的基礎(chǔ)。

5.6. The technology transfer should be managed by responsiblepersons from the SU and RU. A technology transfer team may be appointed withidentified and documented responsibilities.

技術(shù)轉(zhuǎn)讓應(yīng)由轉(zhuǎn)移方和接收方的負(fù)責(zé)人管理,?？梢匀蚊粋€(gè)技術(shù)轉(zhuǎn)移小組，其職責(zé)應(yīng)明確并形成文件,。

5.7. The team members should have the necessary qualifications andexperience to manage the particular aspects of the transfer.

團(tuán)隊(duì)成員應(yīng)該具備必要的資質(zhì)和經(jīng)驗(yàn)來管理轉(zhuǎn)移的特定方面,。

5.8. The SU should make all the necessary information and knowledgewith regard to the product, process or procedure available in relevantdocuments in order to ensure a successful transfer.

轉(zhuǎn)移方應(yīng)在相關(guān)文件中提供與產(chǎn)品、工藝或程序有關(guān)的所有必要信息和知識(shí),，以確保成功的轉(zhuǎn)移,。

5.9. A training programme should be implemented specific to theprocess, product or procedure to be transferred.