版GMP英文版官方.docx

版GMP英文版官方.docx

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版GMP英文版官方

GoodManufacturingPracticeforDrugs（2010Revision）

（MOHDecreeNo.79）

TheGoodManufacturingPracticeforDrugs（2010Revision）,adoptedattheexecutivemeetingoftheMinistryofHealthonOctober19,2010,isherebypromulgatedandshallgointoeffectasofMarch1,2011.

                                                                                             ChenZhu

                                                                                            MinisterofMOH

                                                                                            January17,2011

                                 GoodManufacturingPractice（GMP）forDrugs

                                                Chapter1GeneralProvisions

Article1:

 TheseprovisionsofGoodManufacturingPractice（GMP）forDrugs,inaccordancewiththeDrugAdministrationLawofthePeople’sRepublicofChinaandtheRegulationsforImplementationoftheDrugAdministrationLawofthePeople’sRepublicofChina,areenactedtoregulatethemanufacturingandqualitymanagementofDrugs.

Article2:

 Themanufacturershouldestablishaqualitymanagementsystem.Thesystemshouldcoverallfactorsthatinfluencethequalityofdrugs,includingallorganizedandplannedactivitieswiththeobjectiveofensuringthatthedrugsareofthequalityrequiredfortheirintendeduse.

Article3:

 GMP,aspartofthequalitymanagementsystem,isthebasicrequirementofproductionandqualitycontrolofdrugs,toensuretheproductsareconsistentlymanufacturedinaccordancewiththeregistrationrequirements,andaresuitablefortheirintendeduse,byminimizingtherisksofcontamination,cross-contaminationandmixupsorerrorsinmanufacturingprocess.

Article4:

 ThemanufacturershouldstrictlyimplementGMPwithintegrity.Anyfalsificationandfraudisforbidden.

                                        Chapter2QualityManagement

                                                      Section1Principle

Article5:

 Themanufacturershouldestablishaqualityobjectivetomeetqualitymanagementrequirementssothatallregistrationrequirementsrelatedtodrugsafety,efficacyandqualityaresystematicallyimplementedthroughouttheentireprocessofproduction,control,productrelease,storageanddistribution,toensurethattheproductsaremanufacturedinaccordancewiththeregistrationrequirements,andaresuitablefortheirintendeduse.

Article6:

 Theattainmentofthequalityobjectiveistheresponsibilityofseniormanagementandrequirestheparticipationandcommitmentbystaffatalllevelswithinthemanufacturer,bythemanufacturer’ssuppliersandbythedistributors.

Article7:

 Themanufacturershouldbeadequatelyresourcedwithcompetentpersonnel,suitableandsufficientpremises,equipmentandfacilitiesforachievingitsqualityobjective.

                                                Section2QualityAssurance

Article8:

 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.

                                                 Section3QualityControl

Article11:

 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.

                                           Section4QualityRiskManagement

Article13:

 Qualityriskmanagementisasystematicprocessfortheassessment,control,communicationandreviewoftherisktoqualitythroughouttheentireproductlifecycle.Itcanbeappliedbothproactivelyandretrospectively.

Article14:

 Theevaluationoftherisktoqualityisbasedonscientificknowledgeandexperience,toensurethequalityofproducts.

Article15:

 Thelevelofeffort,formalityanddocumentationofthequalityriskmanagementprocessiscommensuratewiththelevelofrisk.

                                       Chapter3OrganizationandPersonnel

                                                     Section1Principle

Article16:

 Themanufacturershouldestablishamanagementstructureandhaveanorganizationchart.ThequalitymanagementdepartmentshouldbeindependentfromotherdepartmentstocarryoutresponsibilitiesofQualityAssuranceandQualityControl.Thequalitymanagementdepartmentcanbestructuredintothequalityassurancedepartmentandthequalitycontroldepartmentseparately.

Article17:

 Thequalitymanagementdepartmentshouldparticipateinallqualityrelatedactivities,andreviewallGMPrelateddocuments.Theresponsibilitiesofqualitymanagementpersonnelarenotpermittedtobedelegatedtopersonnelofotherdepartments.

Article18:

 Themanufacturershouldhaveanadequatenumberofmanagerialandoperatingpersonnelwithappropriatequalifications（withrespectto,includingeducation,training,andpracticalexperience）.Theresponsibilitiesofeachdepartmentandeachpositionshouldbeclearlyspecified.Thereshouldbenogapsorunexplainedoverlapsintheresponsibilities.Theresponsibilitiesplacedonanyoneindividualshouldnotbeextensive. 

Allpersonnelshouldbefullyawareofandunderstandtheirresponsibilities,befamiliarwithrelatedrequirements,andreceivenecessarytraining,includinginitialtrainingandcontinuingtraining.

Article19:

 Dutiesnormallyshouldnotbedelegatedtootherpersonnel.Ifdeemednecessary,thedutiescanonlybedelegatedtodesignateddeputiesofasatisfactoryqualificationlevel.

                                                 Section2KeyPersonnel

Article20:

 Keypostsshouldbeoccupiedbyfull-timepersonnel,whichshouldatleastincludetheheadsofthemanufacturer,productionmanagement,qualitymanagement,andtheQualifiedPerson. 

Theheadsofproductionandqualitymanagementmustbeindependentfromeachothe