分析仪器及其辅助系统影响性评估表

分析仪器及其辅助设备系统影响性评估,,,,,,,,,,,,,,,,,,,,

影响评估问题,,,,,,,,,,,,,,,,,,,,

1,仪器或仪器产生的数据是否直接影响所做出的关于产品本身或产品质量、纯度、效价的决策？,,,,,,,2,该仪器是否具有测量性能？,,,,,,,,,,,

3,该仪器是否在购买后进行用户校准？,,,,,,,4,该仪器是否测量数值或者控制物理参数？,,,,,,,,,,,

5,该仪器的使用是否采用观察法以外需要更多其他方式？,,,,,,,6,是否具有一个单独的计算机用以控制仪器或者数据采集？,,,,,,,,,,,

上述6个问题按顺序分阶段回答，以“Y”或“N”表示。若问题1回答是“N”，确认和验证是没有必要的，因为该项目对GMP无影响，在GMP影响性一栏填写“N”。若2～4问题的所有回答都是“N”，判定为A类仪器，在判定类型一栏填写“A”。若2～4问题的答案有一个是“Y”，则进行下一阶段的评估。若5～6问题有任何回答是“N”，则判定为B类仪器，在判定类型一栏填写“B”。若5～6问题所有答案都是“Y”，则判定为C类仪器，在判定类型一栏填写“C”。,,,,,,,,,,,,,,,,,,,,

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分析仪器风险评估表,,,,,,,,,,,,,,,,,,,,

序号,系统名称,系统编号,仪器/设备编号,安装位置,使用目的,问题,,,,,,GMP影响性,判定类别,URS,安装确认,运行确认,性能确认,校准,"预防性

维护保养",备注

,,,,,,1,2,3,4,5,6,,,,,,,,,

,十万分之一天平01,,,,用于样品制备,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,十万分之一天平02,,,,用于样品制备,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,万分之一天平01,,,,用于样品制备,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,万分之一天平02,,,,用于样品制备,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,万分之一天平03,,,,用于样品制备,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,千分之一天平01,,,,用于样品制备,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,千分之一天平02,,,,用于称重,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,天平打印机01,,,,用于称量数据打印,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,天平打印机02,,,,用于称量数据打印,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,紫外分光光度仪,,,,用于样品含量测定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,可见分光光度计,,,,用于样品透光度测定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,全自动水分测定仪,,,,用于样品水分测定,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,Y,

,浮游菌仪01,,,,用于环境监控,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,Y,调试

,浮游菌仪02,,,,用于环境监控,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,Y,调试

,细菌菌落计数仪,,,,用于环境监控,Y,Y,N,N,N,N,Y,B,N,Y,Y,N,Y,Y,

,漩涡混合器01,,,,用于内毒素样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,漩涡混合器02,,,,用于内毒素样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,数显鼓风干燥箱01,,,,用于细菌内毒素样品干燥,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,数显鼓风干燥箱02,,,,用于干燥失重样品干燥,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,真空干燥箱,,,,用于样品干燥失重,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,酸度计01,,,,用于pH测定,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,酸度计02,,,,用于pH测定,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,生物显微镜,,,,用于微生物鉴别,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,偏振光显微镜,,,,用于样品性状检查,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,塑料袋封口机（脚踏）01,,,,用于取样样品封口,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,塑料袋封口机（脚踏）02,,,,用于取样样品封口,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,铝箔袋封口机01,,,,用于取样样品封口,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,铝箔袋封口机02,,,,用于取样样品封口,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,集菌仪01,,,,用于样品无菌检查,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,集菌仪02,,,,用于样品无菌检查,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,集菌仪03,,,,用于样品无菌检查,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,生化培养箱（带打印）01,,,,提供微生物培养,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,生化培养箱（带打印）02,,,,提供微生物培养,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,生化培养箱（带打印）03,,,,提供微生物培养,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,生化培养箱（带打印）04,,,,提供微生物培养,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,生化培养箱（带打印）05,,,,提供微生物培养,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,生化培养箱（带打印）06,,,,提供微生物培养,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,生化培养箱（带打印）07,,,,提供微生物培养,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,霉菌培养箱（带打印）01,,,,提供微生物培养,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,霉菌培养箱（带打印）02,,,,提供微生物培养,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,霉菌培养箱（带打印）03,,,,提供微生物培养,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,霉菌培养箱（带打印）04,,,,提供微生物培养,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,微生物限度检测系统01,,,,提供微生物限度检查,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,微生物限度检测系统02,,,,提供微生物限度检查,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,超净工作台01,,,,提供微生物检测洁净环境,Y,N,N,Y,Y,N,Y,B,N,Y,Y,Y,N,Y,

,超净工作台02,,,,提供微生物和检测洁净环境,Y,N,N,Y,Y,N,Y,B,N,Y,Y,Y,N,Y,

,超净工作台03,,,,提供微生物检测洁净环境,Y,N,N,Y,Y,N,Y,B,N,Y,Y,Y,N,Y,

,超净工作台04,,,,提供无菌检测洁净环境,Y,N,N,Y,Y,N,Y,B,N,Y,Y,Y,N,Y,

,台式超声波清洗器01,,,,用于样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,台式超声波清洗器02,,,,用于样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,数字电导率仪01,,,,用于电导率测定,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,数字电导率仪02,,,,用于电导率测定,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,稳定性试验箱（带报警）01,,,,用于样品稳定性试验,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,稳定性试验箱（带报警）02,,,,用于样品稳定性试验,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,稳定性试验箱（带报警）03,,,,用于样品稳定性试验,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,稳定性试验箱（带报警）04,,,,用于样品稳定性试验,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,稳定性试验箱（带报警）05,,,,用于样品稳定性试验,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,药品强光照射试验箱,,,,用于样品稳定性试验,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,压缩空气检测仪,,,,用于压缩空气检查,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,恒温水浴锅(8孔),,,,用于样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,恒温水浴锅(4孔)01,,,,用于样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,恒温水浴锅(4孔)02,,,,用于细菌内毒素样品制备,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,澄明度检测仪01,,,,用于样品可见异物检查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,澄明度检测仪02,,,,用于样品可见异物检查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,澄明度检测仪03,,,,用于样品可见异物检查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,澄明度检测仪04,,,,用于样品可见异物检查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,旋片式真空泵01,,,,用于溶液过滤,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,旋片式真空泵02,,,,用于溶液过滤,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,隔膜真空泵01,,,,用于溶液过滤,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,隔膜真空泵02,,,,用于溶液过滤,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,电动吸引器,,,,用于微生物样品检测,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,电动吸引器,,,,用于微生物样品检测,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,生物安全柜,,,,用于菌种传代,Y,N,N,Y,Y,N,Y,B,Y,Y,Y,Y,Y,Y,

,生物安全柜,,,,用于阳性对照,Y,N,N,Y,Y,N,Y,B,Y,Y,Y,Y,Y,Y,

,振实密度测试仪,,,,用于样品密度检查,Y,Y,N,Y,N,N,Y,B,N,Y,Y,N,N,N,

,旋光仪01,,,,用于样品比旋度检查,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,旋光仪02,,,,用于样品比旋度及效价检查,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,电阻炉01,,,,用于样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,电阻炉02,,,,用于样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,熔点仪,,,,用于样品熔点检测,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,超纯水机,,,,用于实验室超纯水制备,Y,N,N,Y,Y,N,Y,B,N,Y,Y,Y,N,Y,

,西林瓶数显偏光应力仪,,,,用于内包材检查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,圆跳动测试仪,,,,用于内包材检查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,壁厚测厚仪,,,,用于内包材检查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,电子秤（百分之一）01,,,,用于称重,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,Y,

,电子秤（百分之一）02,,,,用于称重,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,Y,

,电子秤（百分之一）03,,,,用于称重,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,Y,

,电子秤（百分之一）04,,,,用于称重,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,Y,

,微波炉,,,,用于样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,电磁炉01,,,,用于样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,电磁炉02,,,,用于样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,红外可控调温电炉01,,,,用于加热,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,红外可控调温电炉02,,,,用于加热,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,红外可控调温电炉03,,,,用于加热,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,单门立式冷柜01,,,,用于样品存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,单门立式冷柜02,,,,用于试剂存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,单门立式冷柜03,,,,用于试剂存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,双门立式冷柜,,,,用于对照品存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,四门立式冷柜,,,,用于培养基存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,卧式冷柜01,,,,用于培养基等存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,卧式冷柜02,,,,用于试剂存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,低温冰箱,,,,用于检定菌存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,冰箱01,,,,用于溶液试剂放置,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,冰箱02,,,,用于溶液试剂放置,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,纯蒸汽灭菌柜01,,,,用于洁净物品灭菌,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,纯蒸汽灭菌柜02,,,,用于洁净物品灭菌,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,纯蒸汽灭菌柜03,,,,用于洁净物品灭菌,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,纯蒸汽灭菌柜04,,,,用于洁净物品灭菌,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,压力蒸汽灭菌柜,,,,用于废物灭活,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,过氧化氢灭菌柜,,,,用于取样间物品消毒,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,检验隔离器01,,,,用于产品无菌检验,Y,N,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,检验隔离器02,,,,用于产品无菌检验,Y,N,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,取样隔离器01,,,,用于无菌样品取样,Y,N,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,全自动高效液相色谱仪01,,,,用于样品含量和杂质测定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,全自动高效液相色谱仪02,,,,用于样品含量和杂质测定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,手动高效液相色谱仪03,,,,用于样品含量和杂质测定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,手动高效液相色谱仪04,,,,用于样品含量和杂质测定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,气相色谱仪01,,,,用于残留溶剂测定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,气相色谱仪02,,,,用于残留溶剂测定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,动态试管检测仪,,,,用于内毒素检测,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,TOC总有机碳分析仪,,,,用于注射用水检测,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,自动永停滴定仪01,,,,用于样品含量检测,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,百特粒度激光仪,,,,用于粒度检测,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,红外光谱仪,,,,用于样品鉴别,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,红外压片机,,,,用于红外样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,红外线快速干燥器,,,,用于红外样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,不溶性微粒仪,,,,用于样品微粒检测,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,离心机01,,,,用于样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,三用紫外仪,,,,样品TLC检测,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,调试

,振荡器,,,,用于样品制备,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,调试

,培养基专用恒温箱,,,,用于培养基培养,Y,N,N,N,N,N,Y,A,N,N,N,Y,Y,Y,

,密封测试仪,,,,铝盖密封性检测,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,密封测试仪,,,,铝盖密封性检测,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,完整性检测仪01,,,,滤芯完整性检测,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,完整性检测仪02,,,,滤芯完整性检测,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,硬度检测仪01,,,,纯化水制备检测,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,硬度检测仪02,,,,纯化水制备检测,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,余氯检测仪01,,,,纯化水制备检测,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,余氯检测仪02,,,,纯化水制备检测,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,浊度检测仪01,,,,纯化水制备检测,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,浊度检测仪02,,,,纯化水制备检测,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,照度计,,,,洁净区环境检测,N,Y,Y,Y,N,N,Y,A,N,N,N,N,Y,N,调试

,风速仪,,,,洁净区环境检测,N,Y,Y,Y,N,N,Y,A,N,N,N,N,Y,N,调试

,转速表,,,,工艺验证,N,Y,Y,Y,N,N,N,A,N,N,N,N,Y,N,调试

,微差压表,,,,洁净区环境检测,N,Y,Y,Y,N,N,N,A,N,N,N,N,Y,N,调试

,直流电阻箱,,,,温度控制仪检定