欢迎来到天天文库
浏览记录
ID:41116278
大小:101.69 KB
页数:4页
时间:2019-08-16
《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
此文档下载收益归作者所有