Computerized system validation and GDP transportat

欧盟实施GMP的经验计算机验证和GDP的运输过程验证DSifidShittPAREXELDrSiegfriedSchmitt,PAREXELEUGMPEXPERIENCE:COMPUTERVALIDATIONANDGDPTRANSPORTATIONVALIDATIONAGENDAComputerSystemsValidationdandGoodDistributionPractice(Transportation)ValidationNewdevelopmentsandrequirementsintheEUandChinapqCOMPUTERSYSTEMSVALIDATIONApplicableRegulationsThelatestGuidanceDocumentsIndustryExperienceTHEEUROPEANUNIONCOMPUTERSYSTEMSVALIDATION-APPLICABLEREGULATIONSEUEudraLexVolume4Annex11ComputerisedSystemsEudraLexVolume4Annex15QualificationandValidationcameintoforceOctober2015(e.g.applicabletoautomatedequipmentITInfrastructure)equipment,ITInfrastructure)(2010Revision)ManufacturingPracticeforDrugs(2010Revision)=open&fun=show_news&nid=6643Article42inAnnex2ValidationandVerification(DraftforCommentMay2015)Annex1ComputerSystems(DraftforCommentMay2015)COMPUTERSYSTEMSVALIDATION-APPLICABLEREGULATIONSCONTINUEDChinaArticles109and241inMOHDecreeNo.79Goodff()ManufacturingPracticeforDrugs(2010Revision)(DraftforCommentJune2014)htt//fd/WS01/CL0778/109640htl(August2015)Registration(August2015)://tinyurl.com/q2th2syHandbookonEuropeandataprotectionlaw://tinyurl.com/olbzgeuSweden-MedicalInformationSystemséi07121202CtlftidGermany-Aide-mémoire07121202Controlofcomputerizedsystems:GoodmanufacturingpracticeEMAQuestionsandanswers:Goodmanufacturingpractice!COMPUTERSYSTEMSVALIDATION-INDUSTRYEXPERIENCECONTINUEDThereisawidespreadmisconceptionthatautomatedsystemswillalwaysmakeapaper/manualprocessbetterMany,manyautomatedsystemsinindustryarenotvalidated,i.e.thevalidationdocumentationisinsufficientThereisgreatreluctanceinindustrytoincreaseautomationThereisgreatreluctanceinindustrytoincreaseautomationand/ortonetworkautomatedsystemsCOMPUTERSYSTEMSVALIDATION-INDUSTRYEXPERIENCECONTINUEDThemostdifficultaspectofCSVareintelligent,completeandtestableuserrequirementspecifications-really,truly,honestlyOnceyouactuallyknowwhattheuserwants,thesystemcanbevalidatednotbefore!!!bevalidated-notbefore!!!DifferentiatebetweenmusthaveandnicetohaverequirementsqConversely,iftheusershavenotdefinedwhattheywant,theymayormaynotgetwhattheywishfor-itwillbejustluckCOMPUTERSYSTEMSVALIDATION-INDUSTRYEXPERIENCECONTINUEDITdoesnotownbusinessapplications-thereisabusinessownerSSomeonewithITskillswillbeabletoexplainthevalidationapproachCommonomissionsandmistakesinCSV:CommonomissionsandmistakesinCSV:ThesystemhasnotbeenvalidatedforitsintendeduseThCSVtdtTheCSVreportdoesnotsay:•ThesystemisvalidatedandmeetstheURS•TherationalewhyyouconsidertestingwascompleteandchallengingCOMPUTERSYSTEMSVALIDATION-INDUSTRYEXPERIENCECONTINUEDCommonomissionsandmistakesinCSV:Testingisnotrisk-based:•Whichfunctionality,configurationordataareGMP-critical?•Howmuchtestingisrequiredforthese(e.g.positive,negativeorchallengetesting)Tryingtoresolvealldeviations-goodluckThereisnosuchthingas100%testingAutomatedtestingtoolsareok-validatethemPart11isnotaproblem-CSVis!GOODDISTRIBUTIONPRACTICE(TRANSPORTATION)VALIDATIONApplicableRegulationsThelatestGuidanceDocumentsIndustryExperienceGDP(TRANSPORTATION)VALIDATION-()APPLICABLEREGULATIONSEUEC(2011/62/EU)FalsifiedMedicinesDirectiveScope:•ControlofAPI(ActivePharmaceuticalIngredients)Importation•SafetyFeatures:auniqueidentifierandananti-tamperingdevice•InternetSales•GoodDistributionPractices://tinyurl.com/6ftor7t(TRANSPORTATION)VALIDATION-()APPLICABLEREGULATIONSEUECFalsifiedMedicinesDirectiveControlofAPIs(ActivePharmaceuticalIngredients)ImportationWhiteListorWrittenConfirmation(TRANSPORTATION)VALIDATION-()APPLICABLEREGULATIONSEUECGuideline2015/C95/01onGoodDistributionPracticeofffactivesubstancesformedicinalproductsforhumanuse(March2015)://tinyurl.com/ohk8wjhEuropeanCommissionGuidelinesonGoodDistributionPracticeofMedicinalProductsforHumanUse://tinyurl.com/d6r22mnGDP(TRANSPORTATION)VALIDATION-()APPLICABLEREGULATIONSChinaGoodSupplyPracticeforPharmaceuticalProductsCFDA()DecreeNo.13(July2015)