GoodManufacturingPracticeforDrugs(2010Revision)(MOHDecreeNo.79)TheGoodManufacturingPracticeforDrugs(2010Revision),adoptedattheexecutivemeetingoftheMinistryofHealthonOctober19,2010,isherebypromulgatedandshallgointoeffectasofMarch1,2011. ChenZhu MinisterofMOH January17,2011 GoodManufacturingPractice(GMP)forDrugs Chapter1GeneralProvisionsArticle1: TheseprovisionsofGoodManufacturingPractice(GMP)forDrugs,inaccordancewiththeDrugAdministrationLawofthePeople’sRepublicofChinaandtheRegulationsforImplementationoftheDrugAdministrationLawofthePeople’sRepublicofChina,areenactedtoregulatethemanufacturingandqualitymanagementofDrugs.Article2: Themanufacturershouldestablishaqualitymanagementsystem.Thesystemshouldcoverallfactorsthatinfluencethequalityofdrugs,includingallorganizedandplannedactivitieswiththeobjectiveofensuringthatthedrugsareofthequalityrequiredfortheirintendeduse.Article3: GMP,aspartofthequalitymanagementsystem,isthebasicrequirementofproductionandqualitycontrolofdrugs,toensuretheproductsareconsistentlymanufacturedinaccordancewiththeregistrationrequirements,andaresuitablefortheirintendeduse,byminimizingtherisksofcontamination,cross-contaminationandmixupsorerrorsinmanufacturingprocess.Article4: ThemanufacturershouldstrictlyimplementGMPwithintegrity.Anyfalsificationandfraudisforbidden. Chapter2QualityManagement Section1PrincipleArticle5: Themanufacturershouldestablishaqualityobjectivetomeetqualitymanagementrequirementssothatallregistrationrequirementsrelatedtodrugsafety,efficacyandqualityaresystematicallyimplementedthroughouttheentireprocessofproduction,control,productrelease,storageanddistribution,toensurethattheproductsaremanufacturedinaccordancewiththeregistrationrequirements,andaresuitablefortheirintendeduse.Article6: Theattainmentofthequalityobjectiveistheresponsibilityofseniormanagementandrequirestheparticipationandcommitmentbystaffatalllevelswithinthemanufacturer,bythemanufacturer’ssuppliersandbythedistributors.Article7: Themanufacturershouldbeadequatelyresourcedwithcompetentpersonnel,suitableandsufficientpremises,equipmentandfacilitiesforachievingitsqualityobjective. Section2QualityAssuranceArticle8: QualityAssuranceisapartofthequalitymanagementsystem.ThemanufacturershouldestablishtheQualityAssurancesystemwiththesupportofacompletedocumentationsystemtoensureitseffectiveoperation. Article9: ThesystemofQualityAssuranceshouldensurethat:1. DrugsaredesignedanddevelopedinawaythattakesaccountoftherequirementsofGMP.2. ProductionandqualitycontroloperationsareincompliancewithGMP.3. Managerialresponsibilitiesareclearlyspecified.4. Arrangementsaremadeforthepurchaseanduseofthecorrectstartingandpackagingmaterials.5. Allnecessarycontrolsonintermediateproductsareeffectivelycarriedout.6. Qualificationsandvalidationsarecarriedout.7. Drugsarecorrectlyprocessed,checked,tested,andverified,accordingtothedefinedprocedures.8. EachbatchofproductsisnotreleasedbeforetheapprovaloftheQualifiedPerson.9. Satisfactoryarrangementsexisttoensurethatthedrugsarestored,distributedandsubsequentlyhandled.10. Self-inspectionisregularlycarriedouttoappraisetheeffectivenessandapplicabilityoftheQualityAssurancesystem,accordingtotheprocedures.Article10: Thebasicrequirementsofproductionandqualitycontrolarethat:1. Allmanufacturingprocessesareclearlydefined,systematicallyreviewedandshowntobecapableofconsistentlymanufacturingdrugsoftherequiredqualityandcomplyingwiththeirspecifications.2. Stepsofmanufacturingprocessesandsignificantchangestotheprocessarevalidated.3. Allnecessaryresourcesareprovidedincluding:1) Appropriatelyqualifiedandtrainedpersonnel;2) Adequatepremisesandspace;3) Suitableequipmentandservices;4) Correctstartingmaterials,packagingmaterialsandlabels;5) Approvedmastermanufacturingdocumentsandoperationprocedures;6) Suitablestorageandtransport.4. Instructionsandproceduresarewritteninclearandunambiguouslanguage.5. Operatorsaretrainedtocarryoutprocedurescorrectly.6. Recordsshouldbemadeduringtheentiremanufactureandanydeviationsareinvestigatedandrecordedaccordingly.7. Recordsofmanufactureanddistribution,whichenablethecompletehistoryofabatchtobetraced,areretainedinacomprehensibleandaccessibleform.8. Thedistributionoftheproductsminimizesanyrisktotheirquality.9. Asystemisavailabletorecallanybatchofproduct,fromsaleorsupply.10. Complaintsaboutmarketedproductsareexamined,thecausesofqualitydefectsinvestigatedandappropriatemeasurestakeninrespectofthedefectiveproductsandtopreventreoccurrence. Section3QualityControlArticle11: QualityControlisconcernedwithorganizationanddocumentation,andwithsampling,testingandetc.,whichensurethatthenecessarytestsareactuallycarriedoutandthatmaterialsorproductsarenotreleased,untiltheirqualityhasbeenjudgedtobesatisfactory.Article12: ThebasicrequirementsofQualityControlarethat:1. Adequatefacilities,equipment,instrumentsandtrainedpersonnelareresourced,toensuretherelatedqualitycontrolactivitiesaredoneeffectivelyandreliably.2. Approvedproceduresareavailableforsampling,inspectionandtestingstartingmaterials,packagingmaterials,intermediate,bulk,andfinishedproducts,andstabilitystudy,andwhereappropriateformonitoringenvironmentalconditions,toensurethecompliancewithGMP.3. Samplesofstartingmaterials,packagingmaterials,intermediate,bulkandfinishedproductsaretakenbyauthorizedpersonnelwithapprovedmethods.4. Testingmethodsarevalidatedorverified.5. Recordsaremadeforsampling,inspectingandtesting.Anydeviationsareinvestigatedandrecorded.6. Recordsaremadeoftheresultsofinspectionandthattestingofmaterials,intermediate,bulk,andfinishedproductsisformallyassessedagainstspecification.7. Sufficientreferencesamplesofstartingmaterialsandfinishedproductsareretainedtopermitfutureinspectionandtestingoftheproductwhennecessary,andthatthefinishedproductisretainedinitsfinalpackageunlessexceptionallylargepackagesareproduced. Section4QualityRiskManagementArticle13: Qualityriskmanagementisasystematicprocessfortheassessment,control,communicationandreviewoftherisktoqualitythroughouttheentireproductlifecycle.Itcanbeappliedbothproactivelyandretrospectively.Article14: Theevaluationoftherisktoqualityisbasedonscientificknowledgeandexperience,toensurethequalityofproducts.Article15: Thelevelofeffort,formalityanddocumentationofthequalityriskmanagementprocessiscommensuratewiththelevelofrisk. Chapter3OrganizationandPersonnel Section1PrincipleArticle16: Themanufacturershouldestablishamanagementstructureandhaveanorganizationchart.ThequalitymanagementdepartmentshouldbeindependentfromotherdepartmentstocarryoutresponsibilitiesofQualityAssuranceandQualityControl.Thequalitymanagementdepartmentcanbestructuredintothequalityassurancedepartmentandthequalitycontroldepartmentseparately.Article17: Thequalitymanagementdepartmentshouldparticipateinallqualityrelatedactivities,andreviewallGMPrelateddocuments.Theresponsibilitiesofqualitymanagementpersonnelarenotpermittedtobedelegatedtopersonnelofotherdepartments.Article18: Themanufacturershouldhaveanadequatenumberofmanagerialandoperatingpersonnelwithappropriatequalifications(withrespectto,includingeducation,training,andpracticalexperience).Theresponsibilitiesofeachdepartmentandeachpositionshouldbeclearlyspecified.Thereshouldbenogapsorunexplainedoverlapsintheresponsibilities.Theresponsibilitiesplacedonanyoneindividualshouldnotbeextensive. Allpersonnelshouldbefullyawareofandunderstandtheirresponsibilities,befamiliarwithrelatedrequirements,andreceivenecessarytraining,includinginitialtrainingandcontinuingtraining.Article19: Dutiesnormallyshouldnotbedelegatedtootherpersonnel.Ifdeemednecessary,thedutiescanonlybedelegatedtodesignateddeputiesofasatisfactoryqualificationlevel. Section2KeyPersonnelArticle20: Keypostsshouldbeoccupiedbyfull-timepersonnel,whichshouldatleastincludetheheadsofthemanufacturer,productionmanagement,qualitymanagement,andtheQualifiedPerson. Theheadsofproductionandqualitymanagementmustbeindependentfromeachother.TheheadofthequalitymanagementandtheQualifiedPersoncanbethesameperson.ProceduresshouldbeestablishedtoensuretheindependenceoftheQualifiedPersonforfulfillingresponsibilities,withoutinterferencefromtheheadofthemanufacturerorotherpersonnel.Article21: TheheadofthemanufacturerTheheadofthemanufacturerisprincipallyliableforproductqualityandroutineoperation.Inordertoachievethemanufacturer’squalityobjectiveandcompliancewithGMP,theheadofthemanufacturershouldprovidenecessaryresources,makeappropriateplan,organizationandcoordination,andensurethatthequalitymanagementdepartmentcanfulfillitsresponsibilitiesindependently.Article22: Theheadofproductionmanagement1. Qualification:Theheadofproductionmanagementshould,ataminimum,possessacollegedegreeinpharmaceuticalorrelevantspecialties(orwithanintermediateprofessionaltechniquecertificateorapharmacist’slicense),withatleastthreeyearsofpracticalexperienceinpharmaceuticalproductionandqualitymanagement,amongwhichatleastoneyearinproductionmanagement,withnecessarytrainingrelatingtotheproductsbeingmanufactured.2. Mainresponsibilities:1) Toensurethatproductsareproducedandstoredaccordingtoapprovedmastermanufacturingdocumentsinordertoobtaintherequiredquality;2) Toensurestrictimplementationoftheproceduresrelatingtoproductionoperations;3) Toensurethatthebatchrecordsofprocessingandpackagingareevaluatedandsignedbyadesignatedpersonbeforetheyaresenttothequalitymanagementdepartment;4) Toensurethatthepremisesandequipmentaremaintainedandservicedtofunctioninasoundoperatingstate;5) Toensurethatthenecessaryvalidationsaredone;6) Toensurethatrequiredinitialandcontinuingtrainingofpersonnelinproductioniscarriedoutandadaptedaccordingtoneed.Article23: Theheadofqualitymanagement1. Qualification:Theheadofthequalitymanagementshould,ataminimum,possessacollegedegreeinpharmaceuticalorrelevantspecialties(orwithanintermediateprofessionaltechniquecertificateorapharmacist’slicense),withatleastfiveyearsofpracticalexperienceinpharmaceuticalproductionandqualitymanagement,amongwhichatleastoneyearinqualitymanagement,withnecessarytrainingrelatingtotheproductsbeingmanufactured.2. Mainresponsibilities:1) Toensurethatallstartingmaterials,packagingmaterials,intermediate,bulkandfinishedproductsmeettheregistrationrequirementsandspecifications;2) Toensurethatthebatchrecordsarereviewedbeforeproductrelease;3) Toensurethatallnecessarytestingiscarriedout;4) Toapprovespecifications,samplinginstructions,testingmethodsandotherqualitymanagementprocedures;5) Toreviewandapproveallqualityrelatedchanges;6) Toensureallsignificantdeviationsandout-of-specificationresultsaretimelyinvestigatedandhandled;7) Toapproveandmonitoranycontractanalysis;8) Tocheckthemaintenanceofpremisesandequipmentforthepurposeofmaintainingasoundoperatingstate;9) Toensurethenecessaryqualificationsorvalidationsaredoneappropriately,andtoreviewandapprovevalidationprotocolsandreports;10) Toensureself-inspectionisdone;11) Toassessandapprovematerialsuppliers;12) Toensureallqualityrelatedcomplaintsaretimelyandproperlyinvestigatedandhandled;13) Toensuretheimplementationofon-goingstabilitystudyandmakethestabilitydataavailable;14) Toensurethattheproductqualityreviewsaredone;15) ToensurethatthenecessaryinitialandcontinuingtrainingofpersonnelinQualityControlandQualityAssuranceiscarriedoutandadaptedaccordingtoneed.Article24: Theheadsofproductionandqualitymanagementgenerallyhavesomeshared,orjointlyexercised,responsibilitiesrelatingtoquality,including:1. Thereviewandapprovalofmastermanufacturingdocuments,procedures,etc;2. Themonitoringofmanufacturingenvironmentandplanthygiene;3. Ensuringthecriticalequipmenthasbeenqualified;4. Ensuringthecompletionofmanufacturingprocessvalidation;5. Ensuringtherequiredinitialandcontinuingtrainingofallrelatedpersonnelofthemanufactureriscarriedoutandadaptedaccordingtoneed;6. Theapprovalandmonitoringofcontractmanufacturers;7. Thedesignationandmonitoringofstorageconditionsformaterialsandproducts;8. Theretentionofrecords;9. ThemonitoringofcompliancewithGMP;10. Themonitoringofthefactorsthatmayaffectproductquality.Article25: QualifiedPerson1. Qualification:TheQualifiedPersonshould,ataminimum,possessacollegedegreeinpharmaceuticalorrelevantspecialties(orwithanintermediateprofessionaltechniquecertificateorapharmacist’slicense),withatleastfiveyearsofpracticalexperienceinpharmaceuticalproductionandqualitymanagement,withworkexperienceinin-processcontrolandqualitytesting.TheQualifiedPersonshouldpossessnecessarytheoreticalknowledgeinrelevantspecialties，betrainedinproductreleasesoastofulfillitsresponsibilitiesindependently. 2. Mainresponsibilities:1) Toparticipateinqualitymanagementactivitiessuchasestablishmentofthequalitysystem,self-inspection,externalqualityaudit,validation,adversedrugreactionreportingandproductrecalls;2) Toberesponsibleforproductreleaseandtoensurethattheproductionandtestingofeachbatchofreleasedproductsareinaccordancewiththerelatedregulations,theregistrationrequirementsandspecifications;3) Priortothereleaseofeachbatch,theQualifiedPersonmustissueareviewrecordforproductreleaseaccordingtotherequirementsintheaboveparagraph2,andarchiveittothebatchrecord. Section3TrainingArticle26: Themanufacturershoulddesignateaspecificdepartmentorperson(s)totakechargeoftrainingactivities.Atrainingprogramandplanreviewedorapprovedbytheheadofproductionmanagementorqualitymanagementshouldbeavailable.Trainingrecordsshouldberetained.Article27: Trainingshouldbeprovidedforallpersonnelinproductionandqualityactivities.Thecontentofthetrainingshouldbeappropriatetotheresponsibilitiesassignedtothem.BesidesthetrainingonthetheoryandpracticeoftheProvisions,thereshouldbetrainingonrelevantlawsandregulations,andjobrelatedresponsibilitiesandskills.Thepracticaleffectivenessofthetrainingshouldbeperiodicallyassessed.Article28: Personnelworkinginhigh-riskareas(e.g.productionareasforhighlyactive,toxic,infectiousorsensitizingmaterials)shouldbegivenspecifictraining.
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