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QC測試所涉及的設備和儀器清單,。清單應包括相關設備和儀器的制造商和型號,。

9.2. Other relevant documentation may include, on a case-by-casebasis as required, drawings; manuals; maintenance procedures and records;calibration procedures and records; as well as procedures such as equipmentset-up, operation and cleaning.

其他相關文件可能包括圖紙(視具體情況而定);手冊;維護程序和記錄;校正程序和記錄;以及設備設置,、操作和清洗等的程序,。

9.3. A review and a side-by-side comparison of equipment andinstruments of the SU and RU should be carried out in terms of their workingprinciple, make and models.

對轉移方和接收方的設備和儀器進行工作原理、制造,、型號等方面的審查和平行對比,。

9.4. Where the review and comparison identify any gaps ordifferences, appropriate action should be taken. This may include theadaptation of existing equipment or acquisition of newequipment. Such action should be taken by following a changemanagement procedure which should be documented.

當審查和比較發(fā)現任何差距或差異時，應采取適當的措施,。可能包括改造現有設備或購置新設備,。這些措施應通過變更管理程序來進行,，并應形成文件,。

9.5. Production volumes and batch sizes at the SU and RU should becompared. Where batch sizes are different, the impact should be assessed andthe appropriate action planned and taken. Other factors relating to equipmentto be reviewed may include: