Case_Study_RMWG-08_Process Deviation – Empty Product Capsules

《Case_Study_RMWG-08_Process Deviation – Empty Product Capsules》由会员上传分享，免费在线阅读，更多相关内容在学术论文-天天文库。

1、ManufacturingTechnologyCommittee–RiskManagementWorkingGroupRiskManagementCaseStudiesProcessDeviation–EmptyProductCaseStudyTitle:CaseNo.RMWG-08CapsulesGMPSystemQuality,ProductionImpacted:AdrugproductsiteproducesPainFree®capsules,whichareindicatedasananti-epilepticandfort

2、reatmentofneuropathicpain.MultiplecustomercomplaintsofIntroduction/emptycapsuleswerereceived.LotABCwasfullydistributedintheUSandnoBackgroundproductremainswithincompanycontrol.Thereisnoevidenceoftampering.Batchrecordreviewindicatedthatduringprocessing,aloosedosatorwasrep

3、lacedontheencapsulationequipment.Followingreplacementandpriortoresumingencapsulation,acceptancetestingofcapsulesproducedrequiredbyStandardOperatingProcedurewasperformedandproductmetrequirements.Furtherinvestigationrevealedthattheloosedosatorcausedemptycapsulestobeproduc

4、ed.Theencapsulationsystemutilizedavacuumsystemtoremoveemptycapsules.Thisemptycapsuleremovalsystemincludesareservoirforholdingemptycapsulesrejectedduringthemanufacturingprocess.Asaresultoftheloosedosator,anatypicallyhighnumberofrejectempty/lowfillcapsuleswereproducedduri

5、ngtheencapsulationoperation,causingthereservoirtobefilledandeventuallyoverflow.Thereservoirwasphysicallylocatedovertheacceptablecapsuleflow.Therefore,itwasdeterminedduringtheinvestigationthatIftheemptycapsulechamberoverflowed,therewaspotentialforrejectedcapsulesfallback

6、intotheacceptablecapsuleexitchuteandbereintroducedtothelot.Sealedbottleswereobtainedfromremaininginventoryofthelot.Of30,661capsulesexamined,151emptyand5lowfillweightcapsuleswerefound.Theinventoryevaluation,onetofiveemptycapsuleswerefoundin46%ofthebottlesevaluated.Inthec

7、urrentcasestudy,themanufacturerdecidestousequalityriskmanagementtoevaluatethepotentialimpactofthedeviation.DefiningtheRiskTheriskquestiondevelopedforthesubjectcasestudyis:QuestionDoasmallnumberofpotentiallowfilloremptycapsulesinasinglebatchofPainFree®capsulesposeanunacc

8、eptablerisktopatients,andsecondarily,tothecompany?SelectingaRiskInthiscasestudyrelatedtoprocessfailure,therisk