药品生产质量管理规范版ENWord文档格式.docx

药品生产质量管理规范版ENWord文档格式.docx

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　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　DirectorZhuCHEN

　　　　　　　　　　　　　　　　　　　　　　　　　　　January17,2011

Chapter1GeneralProvisions

Article1Inordertostandardizegoodmanufacturingforpharmaceuticalproducts,thisRegulationisenactedinaccordancewiththe“DrugAdministrationLawofthePeople’sRepublicofChina”and“TheRegulationontheImplementationofDrugAdministrationLawofthePeople’sRepublicofChina”.

Article2Apharmaceuticalenterpriseshallestablishpharmaceuticalgoods’qualitycontrolsystem.Thesystemshallcontainallfactorswhichmayaffectthequalityofpharmaceuticalgoods,includingallorganizedandplannedactivitiesensuringpharmaceuticalgoods’qualityinaccordancewithintendingpurpose.

Article3ThisRegulationispartofqualitycontrolsystem,isbasicrequirementformanufacturingandqualitycontrolofpharmaceuticalproducts.ThisRegulationaimstoreducetherisksinpharmaceuticalgoods’manufacturingprocessatitsmaximum,suchaspollution,crosspollutionandconfusion,mistake,ensureforcontinuousstablymanufacturingpharmaceuticalgoodsinaccordancewithintendingpurposeandregisteredrequirements.

Article4TheenterpriseshallobeythisRegulationstrictly,insistonhonestyandkeepfaith,prohibitanyostensibleandspuriousactivities.

Chapter2QualityControl

Section1Principle

Article5Theenterpriseshallestablishqualitytargetinaccordancewithpharmaceuticalgoods’qualitycontrolrequirements,carryoutallrequirementsrelatedtosafety,effectiveandqualitycontrolintotheprocessofpharmaceuticalgoods’manufacturing,controlandproducts’discharging,storage,delivering,ensureallpharmaceuticalgoodsareproducedinaccordancewithintendingpurposeandregisteredrequirements.

Article6Senioradministratorinenterpriseshallensuretheachievementofintendingqualitytarget.Personnelindifferentlevelsandprovider,dealershallparticipateinandtakeeachresponsibility.　

Article7Theenterpriseshallequipadequatepersonnel,workshop,establishmentandequipmentinaccordancewithrequirements,andprovideessentialconditionforachievingqualitytarget.

Section2QualityGuarantee

Article8Qualityguaranteeisapartofqualitycontrolsystem.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;

4.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.

Section3QualityControl

Article11Qualitycontrolincludescorrespondingorganization,documentsystemandsampling,testandsoon,toensurematerialorproductsfinishnecessaryexaminationbeforedelivering,andtoverifyitsqualityisinaccordancewiththerequirements.

Article12Basicrequirementsofqualitycontrol:

I.Equipapplicableestablishment,equipment,instrumentandtrainedpersonneltoeffectiveandreliablefinishallrelatedqualitycontrolactivities;

II.Haveapprovedoperaterules,whichusedtosampling,examine,inspectrawmaterial,wrapper,semifinishedproduct,bulkproductandfinishedproductandproducts’stability,monitorenvironmentwhennecessary,toensuretheproductsisinaccordancewiththerequirementsofthisRegulation;

III.Authorizedpersonshallsamplingtorawmaterial,wrapper,semifinishedproduct,bulkproductandfinishedproductaccordingtostatedmethods;

IV.Inspectmethodsshallbeconfirmedandvalidated;

V.Sampling,check,inspectshallberecorded,thewindageshallberesearchedandberecorded;

VI.Material,semifinishedproduct,bulkproductandfinishedproductshallbecheckedandinspectedaccordingtoqualitystandardandberecorded;

VII.Materialandpackagedfinishedproductshallhaveenoughreservedsamplessothatnecessarycheckorinspectshallbetaken;

exceptthefinishedproductwithtoolargepackagecontainer,thereservedsamples’packageshallbethesamewiththefinalpackageofthefinishedproduct.

Section4QualityRiskManagement

Article13Qualityriskmanagementisevaluate,control,communicate,auditsystemprocesstoqualityriskduringthewholeproductlifeperiod,viathemannerofforeseeorreview.

Article14Qualityriskshallevaluateaccordingtoscienceknowledgeandexperienceinordertoensureproducts’quality.

Article15Themethod,measure,formtakeduringthequalityriskmanagementprocessandthedocumentsformedinthesaidprocessshallaccommodatetotheleveloftheexistentrisk.

Chapter3OrganizationandPersonnel

Article16Anenterpriseshallestablishmanagementorganizationwhichaccommodatetothepharmaceuticalgoods’productandhaveitsorganizationframeworkchart.

Theenterpriseshallsetupindependentqualitymanagementdepartment,whichcarriesouttheresponsibilitiesofqualityguaranteeandqualitycontrol.Thequalitymanagementdepartmentcouldsetupqualityguaranteedepartmentandqualitycontroldepartmentrespectively.

Article17Qualitymanagementdepartmentshalltakepartinallactivitiesrelatingtoquality,andtakeresponsibilitytoauditalldocumentsrelatingtothisRegulation.Thepersonnelinqualitymanagementdepartmentshallnotrelegatehisresponsibilitytothepersonnelinotherdepartment.

Article18Theenterpriseshallbestaffedbyanappropriatenumberofmanagementandtechnicalpersonnelwithappropriatequalification（includingeducationbackground,trainingandpracticeexperience）,andtheresponsibilitiesofeachdepartmentandeachstationshallbeclarified.Station’sresponsibilityshallnotbemissedandcrossresponsibilityshallbeprescribedspecifically.Responsibilitytakenbyeachpersonshallnotbeoverfull.

Everypersonshallclearandunderstandhisownresponsibilities,befamiliarwiththerequirementsrelatedtohisresponsibilities,andacceptnecessarytraining,includingpre-jobtrainingandon-jobtraining.

Article19Generally,oneshallnotrelegatehisresponsibilitytootherperson.Iftheresponsibilitiesdoneedtoberelegated,theoneshouldrelegatehisresponsibilitytothedesignatedpersonwhohasequivalentqualification.

Section2ImportantPerson

Article20Theimportantpersonshallbethefull-timepersonoftheenterprise,atleastincludingthedirectoroftheenterprise,directorofmanufacturingmanagement,directorofqualitymanagementandauthorizedpersonofquality.

Directorofqualitymanagementanddirectorofmanufacturingmanagementshallbeindependentofeachother.Directorofqualitymanagementandauthorizedpersonofqualityshallnotbeindependentofeachother.Operationproceduressshallbeestablishedsothatauthorizedpersonofqualitycouldtakehisresponsibilityindependently,withnointerferencefromdirectorofenterpriseandotherperson.

Article21Directorofenterprise

Directorofenterpriseisthemainresponsiblepersonofpharmaceuticalgoods’quality,whocomprehensiveresponsibletothedailymanagementoftheenterprise.Inordertoensurethe