药品生产中对偏差的调查InvestigationofDeviation原料药制造的GMPGMPforAPIManufacture偏差的调查InvestigationofDeviation何谓偏差What’sDeviation定义Definition实例Examples分类Classification偏差的调查InvestigationofDeviation谁来处理偏差 Who’sgoingtodealwithdeviations质量部门的职责Qualityunit(s)responsibility生产作业的职责 ProductionActivitiesresponsibility偏差的调查InvestigationofDeviation如何对待偏差Howshouldwedofordeviations报告 Report调查 Investigate后续检查 Followup归档 Archive何谓偏差What’sDeviation对批准的指令或规定的标准的偏离。Departurefromanapprovedinstructionorestablishedstandard.(ICHAPIGMPGuide)偏差实例DeviationExamples生产操作 Production包装和贴签Packaging&Labeling物料管理 MaterialManagement设施和设备 Facilities&Equipment实验室控制 LaboratoryControls质量部门 QualityUnit验证 Validation员工培训 EmployeeTraining生产操作Production关键工艺参数的实际值超出规定范围Actualresultsforcriticalprocessparametersexceedtheirspecifiedrange实际产率偏离预期范围Actualyieldsdeparturefromtheirexpectedranges包装和贴签Packaging&Labeling所用包装材料无法追溯Thepackagingmaterialsusedarenottraceable发出,使用和退回标签无法平衡Thequantitiesoflabelsissued,used,andreturnedarenotreconciled物料管理MaterialManagement物料供应商未经质量部门核准Thematerialisnotfromthesupplierapprovedbythequalityunit物料容器上没有标上指定的编号、批号或接受号Thecontainersofmaterialarenotidentifiedwiththeassigneddistinctivecode,batch,orreceiptnumber设施和设备Facility&Equipment设施或设备的破损可能会影响产品质量Thedamageonfacilityorequipmentwithpotentialimpactonproductquality关键仪器设备的校验结果不符合规定的标准Calibrationresultsoncriticalinstrumentsorequipmentdonotmeettheapprovedstandards
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