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7.2. Standard operating procedures (SOPs) should be followed,describing actions to be taken during the technology transfer process.

應(yīng)遵循描述在技術(shù)轉(zhuǎn)移過程中應(yīng)采取行動(dòng)的標(biāo)準(zhǔn)操作規(guī)程(SOPs),。

7.3. Records should be maintained for the activities performedduring the technology transfer process (e.g. a technology transfer report). Thereport content should reflect the protocol and SOPs that were followed. Thereport should summarize the scope of the transfer, the critical parameters asobtained in the SU and RU, and the final conclusions of the transfer. The discrepanciesand appropriate actions taken to resolve them should be recorded. Supportive documentswith data, results and other relevant information should be referenced in thereport and be readily available.

技術(shù)轉(zhuǎn)移過程中進(jìn)行的活動(dòng)應(yīng)保持記錄(如技術(shù)轉(zhuǎn)移報(bào)告)。報(bào)告內(nèi)容應(yīng)反映所遵循的方案和SOP,。報(bào)告應(yīng)總結(jié)轉(zhuǎn)移的范圍,，在轉(zhuǎn)移方和接收方中獲得的關(guān)鍵參數(shù)，以及轉(zhuǎn)移的最終結(jié)論,。應(yīng)記錄偏差和為解決偏差而采取的適當(dāng)措施,。數(shù)據(jù)、結(jié)果和其他相關(guān)信息的支持性文件應(yīng)在報(bào)告中引用,，并隨時(shí)可用,。

8. Premises

廠房

8.1. The RU should haveappropriate premises with the layout, construction and finishing to suit the intendedoperations. Utilities such as heating, ventilation and air conditioning, aswell as gas and water systems, should be appropriate for the intended process,product or procedure to be transferred.