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評估應(yīng)進(jìn)一步涵蓋資源,，包括人員,、廠房、設(shè)備和儀器,、公用設(shè)施,、質(zhì)量控制、文件,、計(jì)算機(jī)化系統(tǒng),、確認(rèn)與驗(yàn)證以及廢棄物管理。

4.5. The assessment to determine feasibility and readiness for technologytransfer may include technical, business, regulatory and legal aspects.

確定技術(shù)轉(zhuǎn)移的可行性和準(zhǔn)備情況的評估可能包括技術(shù),、商業(yè),、監(jiān)管和法律方面,。

5. Organization and management

組織和管理

5.1. All technology transfer activities should be organized andplanned.

所有技術(shù)轉(zhuǎn)移活動(dòng)均應(yīng)得到組織和計(jì)劃。

5.2. There should be a formal agreement between the parties whichspecifies the responsibilities of each party before, during and after transfer.The agreement should cover, for example, data management, data integrity,documentation and validation.

雙方之間應(yīng)有一份正式協(xié)議,，具體規(guī)定雙方在轉(zhuǎn)移之前,、期間和之后的責(zé)任。協(xié)議應(yīng)包括,，例如,，數(shù)據(jù)管理，數(shù)據(jù)完整性,，文件記錄和驗(yàn)證,。

5.3. All the necessary activities to be executed during thetechnology transfer project should be identified, organized and documented atthe start of the project. Responsibilities should be defined.

在技術(shù)轉(zhuǎn)移項(xiàng)目開始時(shí)，應(yīng)確定,、組織和記錄技術(shù)轉(zhuǎn)讓項(xiàng)目期間執(zhí)行的所有必要活動(dòng),。應(yīng)該定義責(zé)任。

5.4. The SU should provide the necessary documentation relating tothe process, product or procedure to be transferred.