第1页共75页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第1页共75页GoodManufacturingPracticeforPharmaceuticalProducts(Amendedin2010)SDAOrder#79OrderbyMinistryofHealthofthePeople’sRepublicofChinaPublishedonFebruary12,2011No.79GoodManufacturingPracticeforPharmaceuticalProducts(Amendedin2010)haspassedbyAffairsMeetingonOctober19,2010.ThisRegulationisnowpublishedandshallbeeffectivefromMarch1,2011.DirectorZhuCHENJanuary17,2011Chapter1GeneralProvisionsArticle1Inordertostandardizegoodmanufacturingforpharmaceuticalproducts,thisRegulationisenactedinaccordancewiththe“DrugAdministrationLawofthePeople’sRepublicofChina”and“TheRegulationontheImplementationofDrugAdministrationLawofthePeople’sRepublicofChina”.Article2Apharmaceuticalenterpriseshallestablishpharmaceuticalgoods’qualitycontrolsystem.Thesystemshallcontainallfactorswhichmayaffectthequalityofpharmaceuticalgoods,includingallorganizedandplannedactivitiesensuringpharmaceuticalgoods’qualityinaccordancewithintendingpurpose.Article3ThisRegulationispartofqualitycontrolsystem,isbasicrequirementformanufacturingandqualitycontrolofpharmaceuticalproducts.ThisRegulationaimstoreducetherisksinpharmaceuticalgoods’manufacturingprocessatitsmaximum,suchaspollution,第2页共75页第1页共75页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第2页共75页crosspollutionandconfusion,mistake,ensureforcontinuousstablymanufacturingpharmaceuticalgoodsinaccordancewithintendingpurposeandregisteredrequirements.Article4TheenterpriseshallobeythisRegulationstrictly,insistonhonestyandkeepfaith,prohibitanyostensibleandspuriousactivities.Chapter2QualityControlSection1PrincipleArticle5Theenterpriseshallestablishqualitytargetinaccordancewithpharmaceuticalgoods’qualitycontrolrequirements,carryoutallrequirementsrelatedtosafety,effectiveandqualitycontrolintotheprocessofpharmaceuticalgoods’manufacturing,controlandproducts’discharging,storage,delivering,ensureallpharmaceuticalgoodsareproducedinaccordancewithintendingpurposeandregisteredrequirements.Article6Senioradministratorinenterpriseshallensuretheachievementofintendingqualitytarget.Personnelindifferentlevelsandprovider,dealershallparticipateinandtakeeachresponsibility.Article7Theenterpriseshallequipadequatepersonnel,workshop,establishmentandequipmentinaccordancewithrequirements,andprovideessentialconditionforachievingqualitytarget.Section2QualityGuaranteeArticle8Qualityguaranteeisapartofqualitycontrolsystem.Theenterprisemustestablishqualityguaranteesystem,andestablishintegratedocumentsystematthesametime,inordertoensurethesystem’seffectiverunning.第3页共75页第2页共75页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第3页共75页Article9Qualityguaranteesystemshallensurethefollowing:I.RepresenttherequirementsofthisRegulationinpharmaceuticalgoods’designanddevelopment.II.InaccordancewiththerequirementsofthisRegulationinmanufacturingmanagementandqualitycontrolactivities;III.Specificmanagementresponsibility;IV.Exactstockedandusedrawmaterialandwrapper;V.Effectivecontrolinsemifinishedproduct;VI.Implementofconfirmationandvalidation;VII.Manufacture,examine,inspectanddoubleexaminedaccordingtorulesstrictly;VIII.Eachbatchofproductsshallonlydischargeafterqualityauthorizingperson’sapproval;IX.Applicablemeasurestoensurepharmaceuticalgoods’qualityduringtheprocessofstorage,deliveringandall...
