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1、GUIDELINEFORGOODMANUFACTURINGPRACTICESINSPECTIONS1PANAMERICANNETWORKFORDRUGREGULATORYHARMONIZATIONWORKINGGROUPONGOODMANUFACTURINGPRACTICESMEMBERS*JustinaMolzon*,AssociateDirectorforInternationalPrograms,FDA/USA.GroupCoordinatorArgentina:CarlosChiale;RodolfoMocchetto*,CoordinatorI
2、NAME/ANMATBrazil:AntonioBezerra,SuzanaAvila*,InspecciónyControldeMedicamentos,ANVISACanada:FranceDasereau,StephenMcCaul;LouiseJodoin*,InspectionUnit,HealthCanadaChile:MagadalenaReyes*,InspectorGMP.InstitutodeSaludPública(ISP)Guatemala:EsmeraldaVillagran;JoséLuisAguilar;NormadePin
3、to*,JefeMonitoreoyVigilanciadeMedicamentos,MinisteriodeSaludMexico:RosaMaríaMorales,SuletaGarcía*,COFEPRISVenezuela:ElsaCastejón*,AsesoraDireccióndeDrogasyCosméticos,MinisteriodeSalud.ALIFAR:MiguelMaito,GerenteLaboratoriosFarmacéuticosArgentina;MariselaBenaim*,CIFAR,VenezuelaFIFA
4、RMA,MarcoVega,QA/QCManager,Lilly;CarmenAraujo,LaboratoriosElmor,MariselaPoot,*GSKRegulatoryDirectorResourcePersons:RebeccaRodríguez,NationalExpertDrugsInvestigator.FDA/USAMillieBarber,InternationalProgramaManger,FDA/USASecretariatRosarioD’Alessio,PAHO/WHOJuanaM.DeRodriguez,PAHO-G
5、uatemalaMiguelA.Lopez,PAHO-Venezuela*Currentmembers2INTRODUCTIONThisGuidelineforGoodManufacturingPracticesInspectionforthepharmaceuticalindustrywaspreparedbytheWorkingGrouponGoodManufacturingPractices(WG/GMP),inMay2003.TheGuidelineaddressestherequirementsoftheWHOTechnicalReporton
6、GoodManufacturingPractices#32andtheparticularconsiderationsofallmembersofthegroup.TheWG/GMPproposedaplanforGuidelinevalidation,totheSteeringCommitteeofthePan-AmericanNetworkforDrugRegulatoryHarmonization,whichwasapprovedandwasdevelopedintwoparts:1.TheGuidelinewasimplementationina
7、pilotphaseatvolunteeringpharmaceuticalindustryplants.PAHO/WHOConsultants,DrugRegulatoryOfficersandpeoplefromthepharmaceuticalindustryconductedthepilotimplementationatseveralplantsindifferentcountriesoftheAmericasRegion.Theguidelinewaslaterrevisedaccordingtotheircommentsandsuggest
8、ionsregardingthecontentsandusefulness.2.
