美国GMP指南(英文)

1GUIDELINEFORGOODMANUFACTURINGPRACTICESINSPECTIONS2PANAMERICANNETWORKFORDRUGREGULATORYHARMONIZATIONWORKINGGROUPONGOODMANUFACTURINGPRACTICESMEMBERS*JustinaMolzon*,AssociateDirectorforInternationalPrograms,FDA/USA.GroupCoordinatorArgentina:CarlosChiale;RodolfoMocchetto*,CoordinatorINAME/ANMATBrazil:AntonioBezerra,SuzanaAvila*,InspecciónyControldeMedicamentos,ANVISACanada:FranceDasereau,StephenMcCaul;LouiseJodoin*,InspectionUnit,HealthCanadaChile:MagadalenaReyes*,InspectorGMP.InstitutodeSaludPública(ISP)Guatemala:EsmeraldaVillagran;JoséLuisAguilar;NormadePinto*,JefeMonitoreoyVigilanciadeMedicamentos,MinisteriodeSaludMexico:RosaMaríaMorales,SuletaGarcía*,COFEPRISVenezuela:ElsaCastejón*,AsesoraDireccióndeDrogasyCosméticos,MinisteriodeSalud.ALIFAR:MiguelMaito,GerenteLaboratoriosFarmacéuticosArgentina;MariselaBenaim*,CIFAR,VenezuelaFIFARMA,MarcoVega,QA/QCManager,Lilly;CarmenAraujo,LaboratoriosElmor,MariselaPoot,*GSKRegulatoryDirectorResourcePersons:RebeccaRodríguez,NationalExpertDrugsInvestigator.FDA/USAMillieBarber,InternationalProgramaManger,FDA/USASecretariatRosarioD’Alessio,PAHO/WHOJuanaM.DeRodriguez,PAHO-GuatemalaMiguelA.Lopez,PAHO-Venezuela*Currentmembers3INTRODUCTIONThisGuidelineforGoodManufacturingPracticesInspectionforthepharmaceuticalindustrywaspreparedbytheWorkingGrouponGoodManufacturingPractices(WG/GMP),inMay2003.TheGuidelineaddressestherequirementsoftheWHOTechnicalReportonGoodManufacturingPractices#32andtheparticularconsiderationsofallmembersofthegroup.TheWG/GMPproposedaplanforGuidelinevalidation,totheSteeringCommitteeofthePan-AmericanNetworkforDrugRegulatoryHarmonization,whichwasapprovedandwasdevelopedintwoparts:1.TheGuidelinewasimplementationinapilotphaseatvolunteeringpharmaceuticalindustryplants.PAHO/WHOConsultants,DrugRegulatoryOfficersandpeoplefromthepharmaceuticalindustryconductedthepilotimplementationatseveralplantsindifferentcountriesoftheAmericasRegion.Theguidelinewaslaterrevisedaccordingtotheircommentsandsuggestionsregardingthecontentsandusefulness.2.TheGuidelinewaspublishedinthePAHO/WHOwebpagetopromoteparticipationanddiscussionbyinstitutionsandprofessionalexpertsinthistopic.Thisgaveallthosewhowereinterested,theopportunitytosendsuggestions,comments,ortosimplygivetheiropinion.TheGuidelineremainedinthewebpagesinceJune2004inordertoreceivecommentsandothersinput.Associationslike(ALIFARandFIFARMA)andcountries(Argentina,GuatemalaandVenezuela)alsosenttheircomments.TheGMPWorkingGroupreviewedandanalyzedallthecommentsreceivedandpreparedthisrevisedversionoftheRegionalGuidelineofGMPInspectionfortheAmericas,whichissubmittedforconsiderationtotheIVPanAmericanConferenceonDrugRegulatoryHarmonization.SomeoftheadvantagesoftheGuidelineare:1.TheguidelinewillhelptoestablishthestandardsforGMPinspections;2.Itwillbemorecomprehensivethanwhatisinplaceintheeconomicblocks(countries)andwillsendthemessagethatcountriesneedtoworkasacommunitytomeetestablishedstandards;andtherefore,improvethequalityofpharmaceuticalproducts;3.Itwillserveasaworkmodelnecessaryforcommoncriteria;4.Itshouldnotbeusedasachecklist,butitshouldshowprinciplesimportanttoconsiderinassociationwithaninspection;5.ItcanbeusedasatrainingdocumentforGMPinspections;and6.Itwillbehelpfultocountriesineducatinginspectorswithunifiedcriteria.4TABLEOFCONTENTSCHAPTER1........................................................................................................................................5ADMINISTRATIONANDGENERALINFORMATION.......................................................................5CHAPTER2........................................................................................................................................8PERSONNEL......................................................................................................................................8CHAPTER3......................................................................................................................................10PREMISES........................................................................................................................................10GENERALCONDITIONS.............................................................................................................................10ANCILLARYAREAS.....................................................................................................................................11MAINTENANCE.............................................................................................................................................12CHAPTER4......................................................................................................................................13WATERSYSTEMS...........................................................................................................................13POTABLEWATER...........................................................................................................................13PURIFIEDWATER......................................