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1、BRIEFING1224)TransferofAnalyticalProcedures.分析方法转移AfterpublicationoftheStimuliarticleuTransferofAnalyticalProcedures:APropcGeneralInformationChapter”inPF35(5)Sept.-Oct.2009andbasedoncomrrGeneralChaptersPhysicalAnalysisExpertCommitteeproposesthisnewgenechapter.Theproposedchapterisintendedtobecomeoneo
2、faseriesofgeneralprovidesguidaneeforgenerationofdata(i.e.,qualification,validation,andverificcompendialanalyticalproceduresWhiletheconceptspresentedintheproposectotheverificationprocessesdescribedingeneralchapterVerificationofComper1226，theverificationprocessisfocusedprimarilyonthedrugproductandasef
3、fectsorotherpotentialinterferenceissuesIncontrast,theprocedure-transferqualifyingthereceivinglaboratorytoperformananalyticalprocedurethatwasckvalidatedinanotherlaboratory.分析方法转移程序的目的是为了确认接收的实验室是否可以进行在另一个实验室匚检验方法。(GCPA:H.Pappa.)CorrespondenceNumber_74516Commentdeadline:March31,2011Addthefollowing:122
4、4TRANSFEROFANALYTICALPROCEDURES分析方法转移程序INTRODUCTION前言Testingtothespecificationofanancillarymaterial,intermediate,and/oringredientar对辅料、中间体、和/或药物成分和产品进行检验确定是否符合质量标准对确定制剂成的。分析方法转移程序（TAP）,通常也称作方法转移，该程序就是记录一个实验室由另一个实验室（转移方，也称作转出方）所开发检验方法的过程，并确保接收的实9并有能力按规定进行检验。Thepurposeofthisgeneralinformationalchapter
5、istosummarizethetypesoftransf（includingthepossibilityofwaiverofanyverification,andtooutlinethepotentialcompprotocol.Thischapterdoesnotprovidestatisticalmethodsanddoesnotencompassmicrobiologicalorbiologicalprocedures.该节内容的目的是总结可能存在的分析方法转移的类型，包括可能不需要进行任何确I需包含的内容。该节不包括统计方法，也不包含对微生物和生物检验方法的转移。TYPESOFTRA
6、NSFERSOFANALYTICALPROCEDURES分析方法转移类型TAPcanbeperformedanddemonstratedbyseveralapproachesThemostcommortestingperformedonhomogeneouslotsofthetargetmaterialfromstandardproductssamplesintentionallypreparedforthetest（e.g.,byspikingrelevantaccurateamountsintosamples）.Otherapproachesineludecovalidationbetwe
7、enlaboratories,thecomfvalidationoftheanalyticalproceduresbythereceivingunit,andthetransferwaiver,appropriatelyjustifiedomissionofthetransferprocessTheteststhatwillbetransfertransferactivities,andtheimplementationstrategyshouldbebasedonariskanalysipreviousexperieneeandknowledgeofthereceivingunit,thec
8、omplexityandspecificsandtheprocedure.Inearlydevelopmentphasestheprocedureunderstandingmaybcases,thetransferprocessismorechallengingbecauseofincompleteknowledgeattheprocedure,particularlyitsrobustness.Thismaycomplicatethetransferprocesstvariablestoasystemthatshouldbeassimpleaspossible进行分析方法转移有好儿种方法。其
9、中最常用的方法是：对从生产批次取出的同批次木分，尤其是否方法的耐用性。因为对木应该尽可能简单的系统增加了更多的变动因素,得更复杂。ComparativeTesting对比试验ComparativetestingisthemostcommonmethodforTAPandrequirestheanalysijnumberofsamplesofthesamelotbyboththesendingandreceivingunits.Other;valid,e.g.,ifthereceivingunitmeetsapredeterminedacceptsneecriterionfortheimpuri
10、tyinaspikedproduct.Suchanalysisisbasedonapreapprovedtransferprothedetailsoftheprocedure,thesamplesthatwillbeused,andthepredeterminedincludingacceptablevariability.Meetingtheacceptaneecriteriaandcomparingdalpartiesarewaysofassuringthatbothsendingandreceivingunitsaresimilarlyquaprocedure.进行对比试验是分析方法转移
11、时最常用的方法，需要转出方和接收方同时对同一批族要进行的检验批次数应预先规定）。其他的方法也可能是有效的，例如：对于一个扌收方测定的朵质回收率符合预先规定的标准。所进行的分析应根据预先批准的转移:规定的程序的具体细节，应使用的样品，和预先规定的标准，包括可接受的变异性。规定并且将转岀方和接收方的所得的结果进行比较，可以保证双方都能进行检验，tCovalidationBetweenTwoorMoreLaboratories两个实验室或多个实验室间白Thelaboratorythatperformsthevalidationofananalyticalprocedureisqualifiedtor
12、iManufacturerscaninvolvethereceivingunitinaninterlaboratorycovalidation,includithevalidationteamandtherebyobtainingdatafortheassessmentofreproducibility.madeusingapreapprovedtransferorvalidationprotocolthatprovidesthedetailsof1samplestobeused,andthepredeterminedacceptaneecriteriaGeneralchapterVaiCom
13、pendialProcedures1225providesusefulguidaneeaboutwhichcharacterisTherevalidationorpartialrevalidationisanotheracceptableapproachfortransferofprocedure.Thisapproachismoretimeconsumingthancomparativetesting,andmarfinditmoredifficulttoobservebiasbetweendifferentsites,operators,andinstrumen进行再验证或部份验证是分析方
14、法转移中使用的另一个可行的方法。这种方法比仅作杲生产商更难发现不同场地、不同操作人员和不同仪器之间的偏移。TransferWaiver转移豁免（不需要进行分析方法转移的情况）TheconventionalTAPmaybeomittedundercertaincircumstancesInsuchinstanceisconsideredtobequalifiedtousetheanalyticaltestprocedureswithoutcomparisorinterlaboratorycomparativedata.Thefollowingexamplesgiveincidencesthatm
15、ayjlTAP:在某些特定的情况下，不需要进行常规的分析方法转移。在这种情况下，不需要进行）!实验室间的对比数据，就可认为接收方是有资格进行分析方法的。下而的情况不需要主Thenewproductscompositioniscomparabletothatofanexistingproductand/orthactiveingredientissimilartothatofanexistingproductandisanalyzedbyprocedurereceivingunitalreadyhasexperienee.新产品的成份与已有的品种的成份类似和/或活性药物的浓度与已有产品的浓.用的
16、分析方法，接收方有经验。 Theanalyticalprocedureisthesameorverysimilartoaprocedurealreadyir检验方法与已使用的方法相同或非常相近。 Thepersonnelinchargeofthedevelopment,validation,parativetestingapproachWhenappropriateandasapartofpre-transferactivitishouldprovidetrainingtothereceivingunit,orthereceivingunitshouldruntheproceanyissuesthatmayneedtoberesolvedbeforethetransferprotocolissignedTra
