藥品生產(chǎn)中的偏差調(diào)查

藥品生產(chǎn)中對偏差的調(diào)查

InvestigationofDeviation.偏差的調(diào)查

InvestigationofDeviation何謂偏差What’sDeviation定義Definition實(shí)例Examples分類Classification偏差的調(diào)查

InvestigationofDeviation誰來處理偏差 Who’sgoingtodealwithdeviations

質(zhì)量部門的職責(zé)Qualityunit(s)responsibility生產(chǎn)作業(yè)的職責(zé) ProductionActivitiesresponsibility

偏差的調(diào)查

InvestigationofDeviation如何對待偏差Howshouldwedofordeviations報(bào)告 Report調(diào)查 Investigate后續(xù)檢查 Followup歸檔 Archive何謂偏差

What’sDeviation對批準(zhǔn)的指令或規(guī)定的標(biāo)準(zhǔn)的偏離。Departurefromanapprovedinstructionorestablishedstandard.(ICHAPIGMPGuide)偏差實(shí)例

DeviationExamples生產(chǎn)操作 Production包裝和貼簽Packaging&Labeling物料管理 MaterialManagement設(shè)施和設(shè)備 Facilities&Equipment實(shí)驗(yàn)室控制 LaboratoryControls質(zhì)量部門 QualityUnit驗(yàn)證 Validation員工培訓(xùn) EmployeeTraining生產(chǎn)操作Production關(guān)鍵工藝參數(shù)的實(shí)際值超出規(guī)定范圍Actualresultsforcriticalprocessparametersexceedtheirspecifiedrange實(shí)際產(chǎn)率偏離預(yù)期范圍Actualyields

departurefromtheirexpectedranges包裝和貼簽

Packaging&Labeling所用包裝材料無法追溯Thepackagingmaterialsusedarenottraceable發(fā)出,使用和退回標(biāo)簽無法平衡Thequantitiesoflabelsissued,used,andreturnedarenotreconciled物料管理MaterialManagement物料供應(yīng)商未經(jīng)質(zhì)量部門核準(zhǔn)Thematerialisnotfromthesupplierapprovedbythequalityunit物料容器上沒有標(biāo)上指定的編號(hào)、批號(hào)或接受號(hào)Thecontainersofmaterialarenotidentifiedwiththeassigneddistinctivecode,batch,orreceiptnumber設(shè)施和設(shè)備Facility&Equipment設(shè)施或設(shè)備的破損可能會(huì)影響產(chǎn)品質(zhì)量Thedamageonfacilityorequipmentwithpotentialimpactonproductquality關(guān)鍵儀器設(shè)備的校驗(yàn)結(jié)果不符合規(guī)定的標(biāo)準(zhǔn)Calibrationresultsoncriticalinstrumentsorequipmentdonotmeettheapprovedstandards實(shí)驗(yàn)室控制LaboratoryControls實(shí)際測試結(jié)果不符合質(zhì)量規(guī)格ActualtestingresultsareOutOfSpecifications所用的物料或儀器超出其有效期Thematerialsorinstrumentusedareoutoftheirexpirationdates質(zhì)量部門QualityUnit沒有完整的產(chǎn)品質(zhì)量定期審核報(bào)告NocompleteregularqualityreviewsofAPI沒按規(guī)定進(jìn)行內(nèi)部審計(jì)（自查）Internalaudits(self-inspection)arenotperformedincompliancewiththeprogram驗(yàn)證Validation對驗(yàn)證方案中關(guān)鍵參數(shù)范圍的偏離，或結(jié)果不符合規(guī)定的認(rèn)可標(biāo)準(zhǔn)Departurefromtheparameterrangesofcriticalstepsoracceptancecriteriaintheapprovedvalidationprotocol

員工培訓(xùn)EmployeeTraining員工不具備與其工作相稱的教育、培訓(xùn)和/或經(jīng)歷等資格

Employeesarenotqualifiedbyappropriateeducation,trainingand/orexperiencefortheirjob.偏差分類

Classification從偏差的發(fā)生來分通常有三種Deviationsmayoccurein3classes偶發(fā)事故Incidential有意偏差I(lǐng)ntentional無意偏差Unintentional偏差分類

Classification根據(jù)偏差的潛在影響可分為重大的和非重大的Deviationsmaybetypedascriticalornoncriticalbasedontheirpotentialeffects.偏差分類

Classification重大偏差Criticaldeviation必須進(jìn)行調(diào)查Requireaninvestigation非重大偏差NoncriticalDeviation可以進(jìn)行調(diào)查May

requireaninvestigation誰來處理

Whowillhandleit質(zhì)量部門

QualityUnit(s)

確保已經(jīng)對重大的偏差進(jìn)行了調(diào)查，并已解決。Makingsurethatcriticaldeviationsareinvestigatedandsolved誰來處理

Whowillhandleit生產(chǎn)作業(yè)ProductionActivities

確保所有的生產(chǎn)偏差都已報(bào)告、評價(jià)，對重大的偏差已做了調(diào)查，并記錄結(jié)論。Makingsurethatallproductiondeviationsarereportedandevaluatedandthatcriticaldeviationsareinvestigatedandtheconclusionarerecorded.如何對待偏差Howshouldwedo報(bào)告 Report調(diào)查 Investigate后續(xù)檢查 Followup歸檔 Archive報(bào)告Report發(fā)現(xiàn)偏差的員工及時(shí)記錄下列信息并報(bào)告主管

Recordthefollowinginformation&reporttosupervisorimmediately:時(shí)間、地點(diǎn)Time&place會(huì)受影響的產(chǎn)品及其批號(hào)Productname&lotnumbermaybeaffected偏差描述Descriptionofdeviation已知的原因Explaindeviationasknown報(bào)告Report主管按偏差的實(shí)際情況將其分類Supervisorclassifythedeviation偏差偶發(fā)事故有意偏差無意偏差原因已知影響大原因已知影響小原因未知影響小原因未知影響大影響大永久變更

影響小永久變更影響大非永久變更

影響小非永久變更

重大偏差，需調(diào)查非重大，不需調(diào)查非重大，可調(diào)查原因已知永久變更？變更控制和/或驗(yàn)證原因已知影響大原因已知影響小原因未知影響小原因未知影響大報(bào)告Report記錄不需調(diào)查的偏差的原因、糾正或預(yù)防措施，以及相關(guān)物料的處理意見Recordtheassignablecausefordeviationswithnoinvestigationrequired,correctiveorpreventionaction(s),andproperdispositionoftherelatedmaterial.報(bào)告Report主管在作決定前可咨詢有關(guān)人員Supervisormayconsultwithrelatedperson(s)主管簽署記錄并按規(guī)定流轉(zhuǎn)審核Supervisorsignedtherecordandcirculatesforrevieworapproval調(diào)查Investigation若主管將偏差初定為重要偏差，或無法確定偏差的原因或是否有不良影響，應(yīng)立即會(huì)同質(zhì)量部門進(jìn)行調(diào)查。Iftheinitialexaminationbysupervisordeterminesthedeviationascritical,oritcannotdetermineanassignablecauseorprovideassuranceofnothavingnegativeimpacts,aninvestigationmustbeundertakenjointlybyqualityunitandthesupervisorimmediately.調(diào)查Investigation質(zhì)量部門發(fā)出偏差調(diào)查表，除了登錄偏差記錄表號(hào)或其主要情況外，根據(jù)偏差具體情況，記錄下列部分或全部調(diào)查內(nèi)容。Qualityunitissuesadeviationinvestigationform.Besidesthenumberofdeviationrecordformoritsmaininformation,partorallofthefollowinginvestigationinformationshouldberecordedaccordingtotheindividualcaseofinvestigation.調(diào)查Investigation操作者對程序的知曉和熟練程度Operator’sfamiliarityandcomfortlavelwithprocedures主記錄文件和/或SOP的清晰和準(zhǔn)確度ClarityandaccuracyofMasterRecorddocumentationand/orSOP查閱有關(guān)的記錄Reviewappropriateexecutedrecords調(diào)查Investigation供應(yīng)商的信息Supplierinformation外加的測試結(jié)果Testingresultsconductedadditionally內(nèi)部審計(jì)（自檢）報(bào)告Internalaudit(self-inspection)reports資源分配情況及其有效性Resourceallocationandavailability調(diào)查Investigation滿足下列兩個(gè)條件后調(diào)查才能作結(jié)論Theinvestigationshouldnotconcludeuntilthefollowingtwoconditionsaresatisfied偏差的原因及糾正和預(yù)防措施已確定Anassignablecauseofthedeviationandcorrectiveandpreventiveactionaredetermined對物料的影響已確定Impactstorelatedmaterialaredetermined后續(xù)檢查Follow-up質(zhì)量部門以及與偏差有關(guān)的部門應(yīng)確保糾正和預(yù)防措施已經(jīng)執(zhí)行和／或落實(shí)QualityUnitandthedepartment(s)relatedtothedeviationshouldberesponsibletoensurethatCorrectiveandpreventiveactioncompletedand/orarranged.

后續(xù)檢查Follow-up作必要的變更／驗(yàn)證

NecessaryChanges/Validations進(jìn)行必要的培訓(xùn)

NecessaryTraining歸檔Archive歸檔的文件應(yīng)包括下列內(nèi)容：The

followingdocuments

shouldbearchivedforthedeviation:有物料處理的完整的偏差報(bào)告CompletedDeviationReportwithmaterialdisposition歸檔Archive偏差調(diào)查表Deviationinvestigationform糾正及預(yù)防措施表CorrectiveandpreventiveActionform該簽的名都已簽好Allrequiredsignatureshavebeenobtained歸檔Archive偏差的歸檔可用下列不同的方法，只要有書面程序規(guī)定用哪種方法：Thedocumentsofdeviationmaybearchivedinthefollowingways,aslongasitisdefinedinawrittenprocedure.歸檔Archive所有報(bào)告歸入批生產(chǎn)／測試記錄，質(zhì)量部門只有偏差登記，若要看報(bào)告，就查批記錄；