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喷雾干燥机验证方案.pdf

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喷雾干燥机验证方案.pdf

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...............................................................................3
运行确认 ..................................................................................................................................4
性能确认 ..................................................................................................................................4
9. 变更与偏差 ................................................................................................................... 8
10. 再验证周期 ................................................................................................................... 8
11. 验证的评定和结论 ....................................................................................................... 8
验证结果的审批 ......................................................................................................................8
验证的评定结论 ......................................................................................................................8
12. 附件 .............................................................................................................................. 8
附件A 人员培训、参与情况确认记录 ........................................................................................... 10
附件B 文件资料确认记录 ............................................................................................................... 11
附件C 关键性仪表确认记录 ........................................................................................................... 12
附件D 设备安装确认记录(PAGE1/2) .......................................................................................... 13
附件D 设备安装确认记录(PAGE2/2) .......................................................................................... 14
附件E 设备运行确认记录(PAGE1/3) .....................................................................