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QC測(cè)試所涉及的設(shè)備和儀器清單,。清單應(yīng)包括相關(guān)設(shè)備和儀器的制造商和型號(hào),。

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(guān)文件可能包括圖紙(視具體情況而定);手冊(cè);維護(hù)程序和記錄;校正程序和記錄;以及設(shè)備設(shè)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(duì)轉(zhuǎn)移方和接收方的設(shè)備和儀器進(jìn)行工作原理、制造,、型號(hào)等方面的審查和平行對(duì)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(dāng)審查和比較發(fā)現(xiàn)任何差距或差異時(shí)，應(yīng)采取適當(dāng)?shù)拇胧??？赡馨ǜ脑飕F(xiàn)有設(shè)備或購(gòu)置新設(shè)備。這些措施應(yīng)通過(guò)變更管理程序來(lái)進(jìn)行,，并應(yīng)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: