欧盟官方发布GMP第15附录-确认与验证草案

欧盟官方发布GMP第15附录-确认与验证草案今天(014-02-07)次修订的GMP第15附录-确认与验证草案，预计，这个草案将有巨大的影响，特别是中国gmp有关附录。EUROPEANCOMMISSIONHEALTHANDCONSUMERSDIRECTORATE-GENERALMedicinalProducts–Quality,SafetyandEfficacyBrussels,6February2014SANCO/TSE/Thereceivedcontributionstogetherwiththeidentityofcontributorswillbemadepubliclyavailable,unlessthecontributorobjectstopublicationofhisorherpersonaldataonthegroundsthatsuchpublicationwouldharmhisorherlegitimateinterests.Inthiscasethecontributionmaybepublishedinanonymousform.Otherwisethecontributionwillnotbepublishednorwill,inprinciple,itscontentbetakenintoaccount.Formoreinformationontheprocessingofyourpersonaldatainthecontextofthisconsultation,readthespecificPrivacyStatementavailableat:linktoPrivacyStatementEudraLexTheRulesGoverningMedicinalProductsintheEuropeanUnionVolume4EUGuidelinesforGoodManufacturingPracticeforMedicinalProductsforHumanandVeterinaryUseAnnex15:QualificationandValidationLegalbasisforpublishingthedetailedguidelines:Article47ofDirective2001/83/EContheCommunitycoderelatingtomedicinalproductsforhumanuseandArticle51ofDirective2001/82/EContheCommunitycoderelatingtoveterinarymedicinalproducts.Thisdocumentprovidesguidancefortheinterpretationoftheprinciplesandguidelinesofgoodmanufacturingpractice(GMP)formedicinalproductsaslaiddowninDirective2003/94/ECformedicinalproductsforhumanuseandDirective91/412/EECforveterinaryuse.Statusofthedocument:Revision1Proposeddocumenttimetable:DeadlineforcommentsonthedraftconceptpaperFebruary2013DraftguidelinediscussionintheGMDPIWGJune2013DraftguidelinediscussionwithothergroupsJune–September2013CommentsbyGMDPIWGandPIC/SOctober2013AdoptionofFinalDraftforpublicconsultation–DelayedduetoadditionalGMDPIWGcomments(November2013)–January2014Commissioneuropéenne/EuropeseCommissie,1049Bruxelles/Brussel,BELGIQUE/BELGI?-Tel.[phone]Startofpublicconsultation–delayed(December2013)–February2014Endofpublicconsultation(deadlineforcomments)(March2014)–May2014Re-discussioninGMDPIWGSeptember2014ExpectedadoptionbyECOctober2014Reasonsforchanges:UpdateasperconceptpaperonrevisionofAnnex15.Summaryofchanges:Thischangetoannex15takesintoaccountchangestoothersectionsoftheEU-GMPGuidePartI,Annex11,ICHQ8,Q9,Q10andQ11,QWPguidanceonprocessvalidationandchangesinmanufacturingtechnology.Deadlineforcomingintooperation:tobedetermined.TableofContentsPagePrinciple4General41.OrganisingandPlanningforQualificationand4Validation2.DocumentationincludingVMP53.Qualificationstagesforequipment,facilitiesand6utilities4.ProcessValidation7General7Concurrentvalidation9TraditionalApproach9Continuousprocessverification10Ongoingprocessverification105.VerificationofTransportation116.ValidationofPackaging117.QualificationofUtilities118.ValidationofTestmethods129.Cleaningvalidation1210.Re-qualification1311.ChangeControl1312.Glossary14QUALIFICATIONANDVALIDATIONPrincipleThisAnnexdescribestheprinciplesofqualificationandvalidationwhichareapplicabletothefacilities,equipment,utilitiesandprocessesusedforthemanufactureofmedicinalproducts.ItisaGMPrequirementthatmanufacturer’scontrolthecriticalaspectsoftheirparticularoperationsthroughqualificationandvalidationoverthelifecycleoftheproductandprocess.Anyplannedchangestothefacilities,equipment,utilitiesandprocesses,whichmayaffectthequalityoftheproduct,shouldbeformallydocumentedandtheimpactonthevalidatedstatusorcontrolstrategyassessed.ComputerisedsystemsusedforthemanufactureofmedicinalproductsshouldbevalidatedaccordingtotherequirementsofAnnex11.TherelevantconceptsandguidancepresentedinICHQ8,Q10andQ11shouldalsobetakenintoaccount.GeneralAqualityriskmanagementapproachshouldbeappliedthroughoutthelifecycleofamedicinalproduct.Aspartofaqualityriskmanagementsystem,decisionsonthescopeandextentofvalidationandqualificationshouldbebasedonajustifiedanddocumentedriskassessmentofthefacilities,equipment,utilitiesandprocesses.TheprinciplesinICHQ8,Q9,Q10andQ11orothersystemsguaranteeingatleastthesamelevelofproductqualityandsecurityshouldbeusedtosupportvalidationandqualificationactivities.Datasupportingqualificationand/orvalidationstudieswhichwereobtainedfromsourcesoutsideofthemanufacturersownvalidationprogrammemaybeusedprovidedthatthisapproachhasbeenjustifiedandthatthereisadequateassurancethatcontrolswereinplacethroughouttheacquisitionofsuchdata.1.ORGANISINGANDPLANNINGFORQUALIFICATIONANDVALIDATION1.1Allqualificationandvalidationactivitiesshouldbeplannedandtakethelifecycleofequipment,processandproductintoconsideration.1.2Validationactivitiesshouldonlybeperformedbysuitablytrainedpersonnelwhofollowapprovedvalidationprocedures.1.3Validationpersonnelshouldreportasdefinedinthepharmaceuticalqualitysystemalthoughthismaynotnecessarilybetoaqualitymanagementoraqualityassurancefunction,howeverthereshouldbeappropriateoversightoverthewholevalidationlifecycle.1.4Thekeyelementsofthesitevalidationprogrammeshouldbeclearlydefinedanddocumentedinavalidationmasterplan(VMP)orequivalentdocument.1.5TheVMPshouldbeasummarydocumentwhichisbrief,concise,clearandcontaindataonatleastthefollowing:a)Validationpolicy.b)Theorganisati