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

应遵循描述在技术转移过程中应采取行动的标准操作规程(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.

技术转移过程中进行的活动应保持记录(如技术转移报告)。报告内容应反映所遵循的方案和SOP。报告应总结转移的范围，在转移方和接收方中获得的关键参数，以及转移的最终结论。应记录偏差和为解决偏差而采取的适当措施。数据、结果和其他相关信息的支持性文件应在报告中引用，并随时可用。

8. Premises

厂房

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.