搜索
TestingandInspectiononcomponents,in-processmaterialandfinishedproductsGMPTrainingModule71GeneralRequirements基本要求Doyouhavewrittenprocedurestomonitoreachstageofcomponents,containersandclosures?Showmeanexample.Howdoyouhandleandstoredrugproductcontainersandclosurestopreventcontamination?Aredrugcontainersorclosuresstoredoffthefloorandcanbeeasilyinspected?Doyouhaveanidentificationcodesystemtolabelandtrackthecomponents?Doeseachlothaveastatuslabel,suchasapproved,rejectedorquarantined?2GeneralRequirements基本要求(a)Thereshallbewrittenproceduresdescribinginsufficientdetailthereceipt,identification,storage,handling,sampling,testing,andapprovalorrejectionofcomponentsanddrugproductcontainersandclosures;suchwrittenproceduresshallbefollowed.(b)Componentsanddrugproductcontainersandclosuresshallatalltimesbehandledandstoredinamannertopreventcontamination.(c)Baggedorboxedcomponentsofdrugproductcontainers,orclosuresshallbestoredoffthefloorandsuitablyspacedtopermitcleaningandinspection.(d)Eachcontainerorgroupingofcontainersforcomponentsordrugproductcontainers,orclosuresshallbeidentifiedwithadistinctivecodeforeachlotineachshipmentreceived.Thiscodeshallbeusedinrecordingthedispositionofeachlot.Eachlotshallbeappropriatelyidentifiedastoitsstatus(i.e.,quarantined,approved,orrejected).3总要求•有文字详细说明成份、药品容器、密封件的签收、鉴定、贮存、装运取样、检验和批准或拒收程序，并遵循。•成份、药品容器和密封件应专人管理和在防止污染的环境下贮存。•药品容器的包装袋或包装箱或密封件应离地面放置保持适当间隔，全球清洁和检查。•用明显的已接收的每装货量中的批号代码对成分、药品容器或密封件加以鉴别。此代码用于记录每批货的放置地方。对每批货的情况，如隔离、批准或拒收等作检查。4Receiptandstorageofuntestedcomponents,drugproductcontainers,andclosures接受未经测试原料Doyouperformvisualcheckonreceivedproducts?Beforeacomponentisapproved,wheredoyoustorethem?Howdoyoupreventthembeingusedbeforebeingtestedandapproved?5Receiptandstorageofuntestedcomponents,drugproductcontainers,andclosures原料接收(a)Uponreceiptandbeforeacceptance,eachcontainerorgroupingofcontainersofcomponents,drugproductcontainers,andclosuresshallbeexaminedvisuallyforappropriatelabelingastocontents,containerdamageorbrokenseals,andcontamination.(b)Components,drugproductcontainers,andclosuresshallbestoredunderquarantineuntiltheyhavebeentestedorexamined,whicheverisappropriate,andreleased.Storagewithintheareashallconformtotherequirementsof211.80(generalrequirements).6未检验的成份、药品容器和密封件的接收与贮存•接收时和验收前，对每个或编组的成份容器、药品容器和密封件进行目检，给内容物、容器损坏或拆封和污染等情况作适当的标志。•成份、药品容器各密封件应隔离贮存，直至经检验为止。合格，可发放。在符合211∙80要求的地区中贮存。7Testingandapprovalorrejectionofcomponents,drugproductcontainers,andclosures测试Whichdepartmentwillsample,testandapprovethecomponentforuse?Whatstatisticalmethodareyoufollowingindeterminingsamplesizefortesting?Whatistheacceptancecriteria?Doyoukeepreservesampleforactiveingredients?Howlongandhowmanydoyoukeepthem?8Testingandapprovalorrejectionofcomponents,drugproductcontainers,andclosures测试(a)Eachlotofcomponents,drugproductcontainers,andclosuresshallbewithheldfromuseuntilthelothasbeensampled,tested,orexamined,asappropriate,andreleasedforusebythequalitycontrolunit.(b)Representativesamplesofeachshipmentofeachlotshallbecollectedfortestingorexamination.Thenumberofcontainerstobesampled,andtheamountofmaterialtobetakenfromeachcontainer,shallbebaseduponappropriatecriteriasuchasstatisticalcriteriaforcomponentvariability,confidencelevels,anddegreeofprecisiondesired,thepastqualityhistoryofthesupplier,andthequantityneededforanalysisandreservewhererequiredby211.170.9成份、药品容器和封口物品的试验、批准或拒收•每批成份、药品容器和封口物品，在未经质量部门取样、检查合格前，不准使用。检验合格后发放使用。•收集每批的每一装货量的代表性样品，供检验用。容器数目和每一容器里物质的取样量是有适当的标准的，例如，成份的变异性统计学标准、可信限、要求的精密度、供应商过去的质量历史、21∙170要求分析和留样所需的数量等。10(c)Samplesshallbecollectedinaccordancewiththefollowingprocedures:(1)Thecontainersofcomponentsselectedshallbecleanedwhennecessaryinamannertopreventintroductionofcontaminantsintothecomponent.(2)Thecontainersshallbeopened,sampled,andresealedinamannerdesignedtopreventcontaminationoftheircontentsandcontaminationofothercomponents,drugproductcontainers,orclosures.(3)Sterileequipmentandasepticsamplingtechniquesshallbeusedwhennecessary.(4)Ifitisnecessarytosampleacomponentfromthetop,middle,andbottomofitscontainer,suchsamplesubdivisionsshallnotbecompositedfortesting.(5)Samplecontainersshallbeidentifiedsothatthefollowinginformationcanbedetermined:nameofthematerialsampled,thelotnumber,thecontainerfromwhichthesamplewastaken,thedateonwhichthesamplewastaken,andthenameofthepersonwhocollectedthesample.(6)Containersfromwhichsampleshavebeentakenshallbemarkedtoshowthatsampleshavebeenremovedfromthem.11Howdoyoucleanthecontainersofcomponents?Howdoyouverifyitisclean?Duringtheoperation,howdoyoucontrolcontamination?Doyouidentifysamplecontainerssothatthefollowinginformationcanbedetermined:nameofthematerialsampled,thelotnumber,thecontainerfromwhichthesamplewastaken,thedateonwhichthesamplewastaken,andthenameofthepersonwhocollectedthesample?12收集样品程序用适当的方法，清洁选出成份容器；打开容器，取样，重新封口，防止其内容物受污染和其他成分、药品容器或密封件的污染。必要时，使用灭菌设备和无菌取样技术。如果需要从容器顶部、中部和底部的成分中取样，样品须混合。鉴定样品容器，目的是确定如下资料：被取样的材料名称、批号、被取样的容器，取样日期及样品收集人的名字等。已取样的容器，应作标志，表示样品已取出。13Doyoudoidentitytestforeachcomponentfordrug?Doyoutesteachcomponentforconformitywithallappropriatewrittensp