药品生产中对偏差调查

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1、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Producti

2、onActivitiesresponsibility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Prod

3、uction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Actualyieldsd

4、eparturefromtheirexpectedranges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Thematerialisnotfromthesupplierapprovedbythequalityu

5、nit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Calibrationresultsoncritic

6、alinstrumentsorequipmentdonotmeettheapprovedstandards实验室控制LaboratoryControls实际测试结果不符合质量规格ActualtestingresultsareOutOfSpecifications所用的物料或仪器超出其有效期Thematerialsorinstrumentusedareoutoftheirexpirationdates质量部门QualityUnit没有完整的产品质量定期审核报告NocompleteregularqualityreviewsofA

7、PI没按规定进行内部审计（自查）Internalaudits(self-inspection)arenotperformedincompliancewiththeprogram验证Validation对验证方案中关键参数范围的偏离，或结果不符合规定的认可标准Departurefromtheparameterrangesofcriticalstepsoracceptancecriteriaintheapprovedvalidationprotocol员工培训EmployeeTraining员工不具备与其工作相称的教育、培训和/

8、或经历等资格Employeesarenotqualifiedbyappropriateeducation,trainingand/orexperiencefortheirjob.偏差分类Classification从偏差的发生来分通常有三种Deviationsmayoccurein3cla