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1GoodManufacturingPracticeforPharmaceuticalProducts(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.ThisRegulationaimstoreduce2therisksinpharmaceuticalgoods’manufacturingprocessatitsmaximum,suchaspollution,crosspollutionandconfusion,mistake,ensureforcontinuousstablymanufacturingpharmaceuticalgoodsinaccordancewithintendingpurposeandregisteredrequirements.Article4TheenterpriseshallobeythisRegulationstrictly,insistonhonestyandkeepfaith,prohibitanyostensibleandspuriousactivities.Chapter2QualityControlSection1PrincipleArticle5Theenterpriseshallestablishqualitytargetinaccordancewithpharmaceuticalgoods’qualitycontrolrequirements,carryoutallrequirementsrelatedtosafety,effectiveandqualitycontrolintotheprocessofpharmaceuticalgoods’manufacturing,controlandproducts’discharging,storage,delivering,ensureallpharmaceuticalgoodsareproducedinaccordancewithintendingpurposeandregisteredrequirements.Article6Senioradministratorinenterpriseshallensuretheachievementofintendingqualitytarget.Personnelindifferentlevelsandprovider,dealershallparticipateinandtakeeachresponsibility.Article7Theenterpriseshallequipadequatepersonnel,workshop,establishmentandequipmentinaccordancewithrequirements,andprovideessentialconditionforachievingqualitytarget.Section2QualityGuarantee3Article8Qualityguaranteeisapartofqualitycontrolsystem.Theenterprisemustestablishqualityguaranteesystem,andestablishintegratedocumentsystematthesametime,inordertoensurethesystem’seffectiverunning.Article9Qualityguaranteesystemshallensurethefollowing:I.RepresenttherequirementsofthisRegulationinpharmaceuticalgoods’designanddevelopment.II.InaccordancewiththerequirementsofthisRegulationinmanufacturingmanagementandqualitycontrolactivities;III.Specificmanagementresponsibility;IV.Exactstockedandusedrawmaterialandwrapper;V.Effectivecontrolinsemifinishedproduct;VI.Implementofconfirmationandvalidation;VII.Manufacture,examine,inspectanddoubleexaminedaccordingtorulesstrictly;VIII.Eachbatchofproductsshallonlydischargeafterqualityauthorizingperson’sapproval;IX.Applicablemeasurestoensurepharmaceuticalgoods’qualityduringtheprocessofstorage,deliveringandallsuccedentoperationprocess;X.Accordingtoself-examinerules,examineandevaluatethevalidityandapplicabilityofthequalityguaranteesystemquality.Article10Basicrequirementsofpharmaceuticalgoods’manufacturequalitymanagement:I.Framemanufacturingtechnique,systemicreviewanddemonstrateitcouldcontinuousstablymanufacturingproductsinaccordancewithrequirements;II.Manufacturingtechniqueanditsimportantchangesshallbevalidated;III.Equipallrequiredresources,include,butnotlimitedthefollowing:1.Holdapplicablequalificationandtheeligibletrainedpersonnel;2.Adequateworkshopandspace;3.Applicableequipmentandmaintainguarantee;44.Accuraterawmaterial,wrapperandlabel;5.Approvedtechniquerulesandoperaterules;6.Applicablestorageandfreightcondition.IV.Useaccurateandeasyunderstandlanguagetoframeoperaterules;V.Theoperatepersoncouldaccurateoperateaccordingtooperaterulesaftertraining;VI.Thewholemanufactureprocessshallberecorded.Thewindageshallberesearchedandberecorded;VII.Batchrecordanddeliveringrecordshallbetracedbacktothewholehistoryofthebatchofproducts,andtherecordsshallbesavedappropriatelyandbeeasyconsult;VIII.Reducethequalityriskduringthepharmaceuticalgoods’deliveringprocess;IX.Establishpharmaceuticalgoods’recallsystem,andensureanybatchdeliveredandsoldproductscouldberecalled;X.Surveythereasonsleadingtopharmaceuticalgoods’complaintsandqualityobjections,takemeasurestopreventsimilarqualityobjections.Section3QualityControlArticle11Qualitycontrolincludescorrespondingorganization,documentsystemandsampling,testandsoon,toensurematerialorproductsfinishnecessaryexaminationbeforedelivering,andtoverifyitsqualityisinaccordancewiththerequirements.Article12Basicrequirementsofqualitycontrol:I.Equipapplicableestablishment,equipment,instrumentandtrainedpersonneltoeffectiveandreliablefinishallrelatedqualitycontrolactivities;II.Haveapprovedoperaterules,whichusedtosampling,examine,inspectrawmaterial,wrapper,semifinishedproduct,bulkproductandfinishedproductandproducts’stability