WM3-120三辊蜜丸机确认方案.doc

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1、WM3-120三辊蜜丸机确认方案目录1.确认目的·····································································································Page3of152.确认范围·········································································································Page3of153.职责·································

2、···············································································Page3of154.设备信息·····································································································Page4of155.设计确认·················································································

3、····················Page4of156.安装确认·····································································································Page7of157.设备运行确认·······················································································Page8of158.工艺性能确认··································

4、····························································Page11of159.风险分析·····································································································Page14of1510.校正···································································································

5、·······Page14of1511.培训··········································································································Page15of1512.再确认周期································································································Page15of1513.附录Page15of15························

6、····················································································1.确认目的1.1.通过本次确认，证明WM3-120三辊蜜丸机、YUJ-300自动涂油机能符合口服固体制剂车间大蜜丸制丸岗位制丸的工艺需求。1.2.为制定WM3-120三辊蜜丸机、YUJ-300自动涂油机的标准操作规程和设备预防性维修规程提供合理依据。1.3.为制定口服固体制剂车间大丸制丸岗位标准操作规程、岗位清场操作规程和设备清洁操作规程提供合理依据。2.确认范围2.1.适用于WM3-120三辊蜜丸机、YUJ

7、-300自动涂油机设计确认（DQ）。2.2.适用于WM3-120三辊蜜丸机、YUJ-300自动涂油机安装确认（IQ）。2.3.适用于WM3-120三辊蜜丸机、YUJ-300自动涂油机运行确认（OQ）。2.4.适用于WM3-120三辊蜜丸机、YUJ-300自动涂油机性能确认（PQ）。3.职责质量管理部负责人特殊职能质量受权人﹒负责确认方案及报告的批准质量管理部负责人﹒负责确认中质量管理相关活动的安排﹒负责确认方案及报告的审核QA主任﹒负责确认中的监控工作QC主任﹒关于设备确认中质量控制相关的检验工作生产技