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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、計算機(jī)化系統(tǒng)、確認(rèn)與驗證以及廢棄物管理。

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)移活動均應(yīng)得到組織和計劃。

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)移項目開始時，應(yīng)確定、組織和記錄技術(shù)轉(zhuǎn)讓項目期間執(zhí)行的所有必要活動。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.