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首页 TDV发布2010版GMP非官方英文版

TDV发布2010版GMP非官方英文版.pdf

TDV发布2010版GMP非官方英文版

xixihahha
2011-04-26 0人阅读 举报 0 0 0 暂无简介

简介:本文档为《TDV发布2010版GMP非官方英文版pdf》,可适用于医药卫生领域

   TDVNONOFFICIALTRANSLATIONGMP(Revisedin)OrderfromMinistryofPublicHealth,PRChinaNo"GoodManufacturingPractice(revisedin)"wasapprovedbytheMinistryofHealthonOctober,Itwillcomeintoforcefromst,MarchofMinister:ChenZhuth,Jan,   TDVNONOFFICIALTRANSLATIONContentsGeneralProvisionsQualityManagementGeneralrulesQualityassuranceQualitycontrolQualityRiskManagementOrganizationandpersonnelGeneralrulesKeypersonnelTrainingPersonnelhygieneFacilityandutilitiesGeneralprovisionsProductionareaWarehousingareaQualityControlAreaAuxiliaryareaEquipmentGeneralrulesDesignandinstallationMaintenanceandrepairUseandcleaningCalibrationsWaterfordrugmanufacturingMaterialsandproductsGeneralrulesRawmaterialsandexcipientsIntermediateproductsandbulkproductsPackagingmaterialsFinalproductsMaterialsandproductswhichneedspecialmanagementOtherValidationandqualification   TDVNONOFFICIALTRANSLATIONDocumentmanagementPrinciplesQualityStandardsProcessprocedureBatchproductionrecordsBatchPackagingRecordsOperatingproceduresandrecordsProductionManagementPrinciplePreventcontaminationandcrosscontaminationinprocessofproductionProductionoperationsPackagingoperationsQualitycontrolandqualityassuranceQualityControlLaboratoryManagementSectionReleaseofmaterialsandproductsContinuedstabilitystudyChangeControlDeviationtreatmentCorrectiveandpreventivemeasuresEvaluationandapprovalofsuppliersProductqualityreviewandanalysisComplaintsandadversereactionreportsContractualproductionandanalysisPrincipleTheCompanyTheContractorContractChapterProductshipmentandrecallPrincipleDeliveryandtransportationRecallSelfcheckPrincipleSelfanalysisSupplementaryProvisions   TDVNONOFFICIALTRANSLATIONGeneralProvisionsArticleThispracticeisestablishedaccordingto"DrugAdministrationLawofPRC"and"ImplementationRegulationsofthePRCDrugAdministrationLaw"inordertoregulatedrugproductionqualitycontrolArticlePharmaceuticalcompaniesshouldestablishadrugqualitymanagementsystemThesystemshouldcoverallfactorsthataffectdrugquality,includingalloforganizedandplannedactivitiesthatensurethequalityofmedicinesmeetitsintendeduseArticleThispractice,asapartofqualitymanagementsystem,actsasthebasicrequirementsfordrugproductionmanagementandqualitycontrolwiththeaimofminimizingcontamination,crosscontaminationandconfusion,errorandotherrisksintheprocessofdrugproductiontoensurePharmaceuticalcompaniescanconstantlyproducedrugsmeetingitsintendeduseandregistrationrequirementsArticleEnterprisesshouldstrictlyenforcethepracticeadheretothehonestandtrustworthy,andtoprohibitanyfalse,deceptivebehavior   TDVNONOFFICIALTRANSLATIONQualityManagementGeneralrulesArticleEnterprisesshouldestablishaqualitytargetthatmeetspharmaceuticalqualitymanagementrequirements,applyingallofrequirementsonsafety,efficacyandqualitycontrolrelatedwithdrugregistrationtowholeprocessofdrugproduction,controlandproductrelease,storageandshipmenttoensurethatproductionofpharmaceuticalsmeettheirintendeduseandregistrationrequirementsArticleTopmanagementpersonnelshouldensureimplementationofestablishedqualityobjectivesstaffofdifferentlevels,suppliersanddistributorsshouldworktogetherandassumetheirresponsibilitiesArticleEnterprisesshouldbeequippedwithadequate,qualifiedstaff,facilities,facilitiesandequipmenttoprovidenecessaryconditionsforachievementofqualityobjectivesQualityassuranceArticleQualityassuranceispartofthequalitymanagementsystemEnterprisesmustestablishaqualityassurancesystem,whilebuildingacompletedocumentationsystemtoensureeffectiveoperationofthesystemArticleQualityassurancesystemshouldensurethat:designanddevelopmentofdrugsreflectsrequirementsofthispracticeproductionmanagementandqualitycontrolactivitiesareconsistentwithrequirementsofthisCodemanagementresponsibilitiesareclearlydefinedrawmaterialsandpackagingmaterialspurchasedandusedarecorrecteffectivecontrolofintermediateproductsimplementationofvalidationandverificationperformproduction,analysis,analyzeandreviewstrictlyinaccordancewithprocedureseachbatchcanonlybereleasedwithapprovalofqualifiedpersonappropriatemeasuresfordrugqualityassuranceareavailableinprocessofstorage,shipmentandsubsequentoperationperiodicanalysisandevaluationofvalidityandapplicabilityofqualityassurancesysteminaccordancewithselfanalysisoperatingproceduresArticle:ThebasicrequirementsforPharmaceuticalproductionandqualitymanagement:   TDVNONOFFICIALTRANSLATION(a)Todevelopproductionprocess,andperformsystematicreviewtocertifyitcansustainablyandstablymanufacturequalifiedproducts(b)Productiontechnologyandmajorchangesneedtobevalidated(c)Equippedwithnecessaryresources,includingatleastthefollowing:PersonnelwithappropriatequalificationsandqualifiedbytrainingAdequatepremisesandfacilityProperequipmentandmaintenancesupportRightrawmaterials,packagingmaterialsandlabelsApprovedproceduresandoperationproceduresAppropriatestorageconditions(d)Accurateandunderstandablelanguageshouldbeusedtodevelopoperationprocedures(e)Theoperatorsaretrainedtooperateinaccordancewithproperoperatingprocedures(f)Productionprocessshouldbedocumenteddeviationsshouldbeinvestigatedandrecorded(g)Batchrecordsandshippingrecordsshouldallowtraceabilityofcompletehistoryofbatchproducts,andshouldbekeptproperlyforeasyreference(h)Reducequalityriskinprocessofdrugshipment(i)Establishmentofdrugrecallsystemshouldensureanybatchcanberecalledafterdistribution(j)InvestigatecomplaintsandqualitydefectsandtakemeasurestopreventrecurrenceofsimilarqualitydefectsQualitycontrolArticle:Qualitycontrol,includingrelatedorganization,documentationsystem,andsampling,andanalysistoensurematerialsorproductscompletetheirnecessaryanalysispriortoreleaseandtoconfirmqualitymeetrequirementsArticle:Thebasicrequirementsofqualitycontrol:(a)QCshallbeequippedwithappropriatefacilities,equipment,instrumentsandtrainedpersonnelforeffectiveandreliablecompletionofallrelatedqualitycontrolactivities(b)Operatingproceduresshouldbeavailableforsampling,analysis,testofrawmaterials,packagingmaterials,intermediateproducts,packagingandfinishedproductsaswellasstabilityanalysisoftheproduct,andifnecessary,carryoutenvironmentalmonitoringtoensurecompliancewiththerequirementsofthispractice(c)Authorizedpersonnelshouldsamplerawmaterials,packagingmaterials,intermediateproducts,packagingandfinishedproductsinaccordancewithrequiredmethod(d)Analysismethodsshouldbevalidatedorconfirmed(e)Sampling,analysis,andcheckshouldberecorded,anddeviationsshouldbeinvestigatedandrecorded(f)Materials,intermediateproducts,packagingandfinishedproductsmustbecheckedandanalyzedaccordingtoqualitystandardsandshouldberecorded   TDVNONOFFICIALTRANSLATION(g)Packagingmaterialsandfinalproductshouldhavesufficientretainedsamplesfornecessaryanalysisorcheckexceptthefinalfinishedpackagingcontainerthatistoolarge,retainedsamplesforfinishedproductshouldbepackagedthesameasfinalpackagingQualityRiskManagementArticleQualityriskmanagement,akindofprospectiveandretrospectivemethod,isasystematicprocesstoevaluate,control,communication,reviewthequalityriskArticleQualityrisksshouldbeevaluatedonbasisofscientificknowledgeandexperiencetoensureproductqualityArticle:Themethods,measures,formsanddocumentsformedintheprocessofqualityriskmanagementprocessshouldbeappropriatetothelevelofexistingrisk   TDVNONOFFICIALTRANSLATIONOrganizationandpersonnelGeneralrulesArticleEnterprisesshouldestablishamanagementstructureappropriatetodrugmanufacturingandorganizationalstructurechartEnterprisesshouldestablishanindependentqualitycontroldepartmenttoperformqualityassuranceandqualitycontrolresponsibilitiesQualityassurancedepartmentandqualitycontroldepartmentscanbeestablishedseparatelywithinqualitymanagementdepartmentArticleQualitycontroldepartmentshouldbeinvolvedinallqualityrelatedactivities,andresponsibleforreviewingalldocumentsrelevanttothispracticeQualitymanagementpersonnelshallnotdelegateresponsibilitiestootherdepartmentsArticleEnterprisesshouldbeequippedwithadequateandsuitablyqualified(includingeducation,trainingandpracticalexperience)managementandoperationsstaffresponsibilitiesofeachdepartmentandeachpositionshouldbeclearlydefinedResponsibilitiescannotbemissed,andoverlappedresponsibilitiesshouldbeclarifiedResponsibilitiesofeachpersonshouldnotbeoverburdenAllpersonnelshouldbeclearaboutandunderstandtheirresponsibilities,familiarwithrequirementsrelatedtotheirdutiesandreceivepropertraiing,includingpreservicetrainingandcontinuingtrainingArticle:NormallyresponsibilitiesshouldnotbedelegatedtoothersTheresponsibilitieswhichareindefiniteneedofdelegationcanbedelegatedtothequalifiedanddesignatedpersonnelKeypersonnelArticleKeypersonnelshouldbefulltimestaffintheenterprise,atleastincludingresponsibleperson,personinchargeofproductionmanagement,qualitymanagementandqualifiedpersonPersonresponsibleforqualitycontrolandproductionmanagementshallnotserveeachotherPersonresponsibleforqualitymanagementandqualityqualifiedcanserveeachotherOperatingproceduresshouldbedevelopedtoensurequalifiedpersonnelperformtheirdutiesindependently,freefrominterferencefrombusinessleadersandotherpersonnelArticleOwnersofenterprisesTheresponsiblepersonforenterprise,astheprimaryresponsiblepersonfortheenterprise,shouldcoveroverallresponsibilityfordailymanagementofenterprisesThe   TDVNONOFFICIALTRANSLATIONresponsiblepersonsshallberesponsibleforprovidingnecessaryresources,rationalplanning,organizationandcoordinationtoensureindependentperformanceofresponsibilitiesofqualitymanagementdepartmentinordertoensurerealizationofbusinessobjectivesandproductionofpharmaceuticalsinaccordancewiththeregulatoryrequirementsArticlePersoninchargeofproductionmanagementQualifications:Personinchargeofproductionmanagementshouldatleasthaveadegreeinpharmacy(orintermediateprofessionaltitlesorLicensedPharmacist)withatleastthreeyears’engagementindrugproductionandqualitymanagementexperience,includingatleastoneyearofmedicineproductionmanagementexperience,andhavebeentrainedonprofessionalknowledgerelatingtomanufacturedproductMainresponsibilities:ToensuredrugsaremanufacturedandstoredinaccordancewithapprovedprocessprocedurestoensuredrugqualityToensurestrictimplementationofalloperationproceduresrelatedtotheoperationandproductionToensurebatchproductionandpackagingrecordshavebeenreviewedandsenttoqualitymanagementdepartmentToensureimplementationoffacilitiesandequipmentmaintenanceforgoodrunningconditionToensurecompletionofallnecessaryvalidationToensurepersonnelrelatedtoproductionreceivenecessarypreservicetrainingandcontinuingtraining,andadjusttrainingcontentsbasingonactualneedsArticlePersonalinchargeofqualitymanagementQu

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