药品生产中的偏差调查.ppt

药品生产中对偏差的调查InvestigationofDeviation,.,偏差的调查InvestigationofDeviation,何谓偏差WhatsDeviation定义Definition实例Examples分类Classification,.,偏差的调查InvestigationofDeviation,谁来处理偏差Whosgoingtodealwithdeviations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WhatsDeviation,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,.,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NocompleteregularqualityreviewsofAPI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/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Deviationsmayoccurein3classes偶发事故Incidential有意偏差Intentional无意偏差Unintentional,.,偏差分类Classification,根据偏差的潜在影响可分为重大的和非重大的Deviationsmaybetypedascriticalornoncriticalbasedontheirpotentialeffects.,.,偏差分类Classification,重大偏差Criticaldeviation必须进行调查Requireaninvestigation非重大偏差NoncriticalDeviation可以进行调查Mayrequireaninvestigation,.,谁来处理Whowillhandleit,质量部门QualityUnit(s)确保已经对重大的偏差进行了调查，并已解决。Makingsurethatcriticaldeviationsareinvestigatedandsolved,.,谁来处理Whowillhandleit,生产作业ProductionActivities确保所有的生产偏差都已报告、评价，对重大的偏差已做了调查，并记录结论。Makingsurethatallproductiondeviationsarereportedandevaluatedandthatcriticaldeviationsareinvestigatedandtheconclusionarerecorded.,.,如何对待偏差Howshouldwedo,报告Report调查Investigate后续检查Followup归档Archive,.,报告Report,发现偏差的员工及时记录下列信息并报告主管Recordthefollowinginformation&reporttosupervisorimmediately:时间、地点Time&place会受影响的产品及其批号Productname&lotnumbermaybeaffected偏差描述Descriptionofdeviation已知的原因Explaindeviationasknown,.,报告Report,主管按偏差的实际情况将其分类Supervisorclassifythedeviation,.,偏差,偶发事故,有意偏差,无意偏差,重大偏差，需调查,非重大，不需调查,非重大，可调查,原因已知,永久变更？,变更控制和/或验证,.,报告Report,记录不需调查的偏差的原因、纠正或预防措施，以及相关物料的处理意见Recordtheassignablecausefordeviationswithnoinvestigationrequired,correctiveorpreventionaction(s),andproperdispositionoftherelatedmaterial.,.,报告Report,主管在作决定前可咨询有关人员Supervisormayconsultwithrelatedperson(s)主管签署记录并按规定流转审核Supervisorsignedtherecordandcirculatesforrevieworapproval,.,调查Investigation,若主管将偏差初定为重要偏差，或无法确定偏差的原因或是否有不良影响，应立即会同质量部门进行调查。Iftheinitialexaminationbysupervisordeterminesthedeviationascritical,oritcannotdetermineanassignablecauseorprovideassuranceofnothavingnegativeimpacts,aninvestigationmustbeundertakenjointlybyqualityunitandthesupervisorimmediately.,.,调查Investigation,质量部门发出偏差调查表，除了登录偏差记录表号或其主要情况外，根据偏差具体情况，记录下列部分或全部调查内容。Qualityunitissuesadeviationinvestigationform.Besidesthenumberofdeviationrecordformoritsmaininformation,partorallofthefollowinginvestigationinformationshouldberecordedaccordingtotheindividualcaseofinvestigation.,.,调查Investigation,操作者对程序的知晓和熟练程度Operatorsfamiliarityandcomfortlavelwithprocedures主记录文件和/或SOP的清晰和准确度ClarityandaccuracyofMasterRecorddocumentationand/orSOP查阅有关的记录Reviewappropriateexecutedrecords,.,调查Investigation,供应商的信息Supplierinformation外加的测试结果Testingresultsconductedadditionally内部审计（自检）报告Internalaudit(self-inspection)reports资源分配情况及其有效性Resourceallocationandavailability,.,调查Investigation,满足下列两个条件后调查才能作结论Theinvestigationshouldnotconcludeuntilthefollowingtwoconditionsaresatisfied偏差的原因及纠正和预防措施已确定Anassignablecauseofthedeviationandcorrectiveandpreventiveactionaredetermined对物料的影响已确定Impactstorelatedmaterialaredetermined,.,后续检查Follow-up,质量部门以及与偏差有关的部门应确保纠正和预防措施已经执行和或落实QualityUnitandthedepartment(s)relatedtothedeviationshouldberesponsibletoensurethatCorrectiveandpreventiveactioncompletedand/orarranged.,.,后续检查Follow-up,作必要的变更验证NecessaryChanges/Validations进行必要的培训NecessaryTraining,.,归档Archive,归档的文件应包括下列内容：Thefollowingdocumentsshouldbearchivedforthedeviation:有物料处理的完整的偏差报告CompletedDeviationReportwithmaterialdisposition,.,归档Archive,偏差调查表Deviationinvestigationform纠正及预防措施表CorrectiveandpreventiveActionform该签的名都已签好Allrequiredsignatureshavebeenobtained,.,归档Archive,偏差的归档可用下列不同的方法，只要有书面程序规定用哪种方法：Thedocumentsofdeviationmaybearchivedinthefollowingways,aslongasitisdefinedinawrittenprocedure.,.,归档Archive,所有报告归入批生产测试记录，质量部门只有偏差登记，若要看报告，就查批记录；Alldeviationdocumentsarekeptwithbatchproduction/controlrecords,qualityunitonlykeepsalogbook.Checkthebatchrecordfordeviationdocumentreview,.,归档Archive,在质量部门有偏差档案，各部门可以写偏差报告，但是，正式报告和有关文件保存在质量部门。Thereisadeviationfileinqualityunit.Thedeviationreportmaybewrittenbyrelateddepartments,buttheofficialreportandotherdocumentsshoul