M4 Quality Step4 sept02.docx
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M4QualityStep4sept02
INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE
ICHHarmonisedTripartiteGuideline
TheCommonTechnicalDocumentforthe
RegistrationofPharmaceuticalsforHumanUse:
Quality–M4Q
QualityOverallSummaryofModule2
Module3:
Quality
HavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeeting
on9November2000,thisguidelineisrecommendedfor
adoptiontothethreeregulatorypartiestoICH
(NumberingandSectionHeadershavebeeneditedforconsistencyanduseine-CTDasagreedattheWashingtonDCMeeting,September11-12,2002)
ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.
TheCommonTechnicalDocumentforthe
RegistrationofPharmaceuticalsforHumanUse:
Quality
QualityOverallSummaryofModule2
Module3:
Quality
ICHHarmonisedTripartiteGuideline
HavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeeting
on9November2000,thisguidelineisrecommendedfor
adoptiontothethreeregulatorypartiestoICH
(NumberingandSectionHeadershavebeeneditedforconsistencyanduseine-CTDasagreedattheWashingtonDCMeeting,September11-12,2002)
TABLEOFCONTENTS
MODULE2:
COMMONTECHNICALDOCUMENTSUMMARIES1
2.3:
QUALITYOVERALLSUMMARY(QOS)1
INTRODUCTION1
2.3.SDRUGSUBSTANCE(NAME,MANUFACTURER)1
2.3.S.1GeneralInformation(name,manufacturer)1
2.3.S.2Manufacture(name,manufacturer)1
2.3.S.3Characterisation(name,manufacturer)2
2.3.S.4ControlofDrugSubstance(name,manufacturer)2
2.3.S.5ReferenceStandardsorMaterials(name,manufacturer)2
2.3.S.6ContainerClosureSystem(name,manufacturer)2
2.3.S.7Stability(name,manufacturer)2
2.3.PDRUGPRODUCT(NAME,DOSAGEFORM)3
2.3.P.1DescriptionandCompositionoftheDrugProduct(name,dosageform)3
2.3.P.2PharmaceuticalDevelopment(name,dosageform)3
2.3.P.3Manufacture(name,dosageform)3
2.3.P.4ControlofExcipients(name,dosageform)3
2.3.P.5ControlofDrugProduct(name,dosageform)3
2.3.P.6ReferenceStandardsorMaterials(name,dosageform)3
2.3.P.7ContainerClosureSystem(name,dosageform)3
2.3.P.8Stability(name,dosageform)3
2.3.AAPPENDICES4
2.3.A.1FacilitiesandEquipment(name,manufacturer)4
2.3.A.2AdventitiousAgentsSafetyEvaluation
(name,dosageform,manufacturer)4
2.3.A.3Excipients4
2.3.RREGIONALINFORMATION4
Module3:
Quality5
3.1.TABLEOFCONTENTSOFMODULE35
3.2.BODYOFDATA5
3.2.SDRUGSUBSTANCE(NAME,MANUFACTURER)5
3.2.S.1GeneralInformation(name,manufacturer)5
3.2.S.1.1Nomenclature(name,manufacturer)5
3.2.S.1.2Structure(name,manufacturer)6
3.2.S.1.3GeneralProperties(name,manufacturer)6
3.2.S.2Manufacture(name,manufacturer)6
3.2.S.2.1Manufacturer(s)(name,manufacturer)6
3.2.S.2.2DescriptionofManufacturingProcessandProcessControls(name,manufacturer)6
3.2.S.2.3ControlofMaterials(name,manufacturer)8
3.2.S.2.4ControlsofCriticalStepsandIntermediates(name,manufacturer)8
3.2.S.2.5ProcessValidationand/orEvaluation(name,manufacturer)8
3.2.S.2.6ManufacturingProcessDevelopment(name,manufacturer)9
3.2.S.3Characterisation(name,manufacturer)9
3.2.S.3.1ElucidationofStructureandotherCharacteristics(name,manufacturer)9
3.2.S.3.2Impurities(name,manufacturer)10
3.2.S.4ControlofDrugSubstance(name,manufacturer)10
3.2.S.4.1Specification(name,manufacturer)10
3.2.S.4.2AnalyticalProcedures(name,manufacturer)10
3.2.S.4.3ValidationofAnalyticalProcedures(name,manufacturer)10
3.2.S.4.4BatchAnalyses(name,manufacturer)10
3.2.S.4.5JustificationofSpecification(name,manufacturer)10
3.2.S.5ReferenceStandardsorMaterials(name,manufacturer)10
3.2.S.6ContainerClosureSystem(name,manufacturer)10
3.2.S.7Stability(name,manufacturer)11
3.2.S.7.1StabilitySummaryandConclusions(name,manufacturer)11
3.2.S.7.2Post-approvalStabilityProtocolandStabilityCommitment(name,manufacturer)11
3.2.S.7.3StabilityData(name,manufacturer)11
3.2.PDRUGPRODUCT(NAME,DOSAGEFORM)11
3.2.P.1DescriptionandCompositionoftheDrugProduct(name,dosageform)11
3.2.P.2PharmaceuticalDevelopment(name,dosageform)12
3.2.P.2.1ComponentsoftheDrugProduct(name,dosageform)12
3.2.P.2.1.1DrugSubstance(name,dosageform)12
3.2.P.2.1.2Excipients(name,dosageform)12
3.2.P.2.2DrugProduct(name,dosageform)12
3.2.P.2.2.1FormulationDevelopment(name,dosageform)12
3.2.P.2.2.2Overages(name,dosageform)12
3.2.P.2.2.3PhysicochemicalandBiologicalProperties(name,dosageform)12
3.2.P.2.3ManufacturingProcessDevelopment(name,dosageform)12
3.2.P.2.4ContainerClosureSystem(name,dosageform)13
3.2.P.2.5MicrobiologicalAttributes(name,dosageform)13
3.2.P.2.6Compatibility(name,dosageform)13
3.2.P.3Manufacture(name,dosageform)13
3.2.P.3.1Manufacturer(s)(name,dosageform)13
3.2.P.3.2BatchFormula(name,dosageform)13
3.2.P.3.3DescriptionofManufacturingProcessandProcessControls(name,dosageform)13
3.2.P.3.4ControlsofCriticalStepsandIntermediates(name,dosageform)14
3.2.P.3.5ProcessValidationand/orEvaluation(name,dosageform)14
3.2.P.4ControlofExcipients(name,dosageform)14
3.2.P.4.1Specifications(name,dosageform)14
3.2.P.4.2AnalyticalProcedures(name,dosageform)14
3.2.P.4.3ValidationofAnalyticalProcedures(name,dosageform)14
3.2.P.4.4JustificationofSpecifications(name,dosageform)14
3.2.P.4.5ExcipientsofHumanorAnimalOrigin(name,dosageform)14
3.2.P.4.6NovelExcipients(name,dosageform)15
3.2.P.5ControlofDrugProduct(name,dosageform)15
3.2.P.5.1Specification(s)(name,dosageform)15
3.2.P.5.2AnalyticalProcedures(name,dosageform)15
3.2.P.5.3ValidationofAnalyticalProcedures(name,dosageform)15
3.2.P.5.4BatchAnalyses(name,dosageform)15
3.2.P.5.5CharacterisationofImpurities(name,dosageform)15
3.2.P.5.6JustificationofSpecification(s)(name,dosageform)15
3.2.P.6ReferenceStandardsorMaterials(name,dosageform)15
3.2.P.7ContainerClosureSystem(name,dosageform)15
3.2.P.8Stability(name,dosageform)16
3.2.P.8.1StabilitySummaryandConclusion(name,dosageform)16
3.2.P.8.2Post-approvalStabilityProtocolandStabilityCommitment(name,dosageform)16
3.2.P.8.3StabilityData(name,dosageform)16
3.2.AAPPENDICES16
3.2.A.1FacilitiesandEquipment(name,manufacturer)16
3.2.A.2AdventitiousAgentsSafetyEvaluation(name,dosageform,
manufacturer)16
3.2.A.3Excipients17
3.2.RREGIONALINFORMATION17
3.3LITERATUREREFERENCES18
MODULE2:
COMMONTECHNICALDOCUMENTSUMMARIES
2.3:
QUALITYOVERALLSUMMARY(QOS)
TheQualityOverallSummary(QOS)isasummarythatfollowsthescopeandtheoutlineoftheBodyofDatainModule3.TheQOSshouldnotincludeinformation,dataorjustificationthatwasnotalreadyincludedinModule3orinotherpartsoftheCTD.
TheQOSshouldincludesufficientinformationfromeachsectiontoprovidetheQualityreviewerwithanoverviewofModule3.TheQOSshouldalsoemphasisecriticalkeyparametersoftheproductandprovide,forinstance,justificationincaseswhereguidelineswerenotfollowed.TheQOSshouldincludeadiscussionofkeyissuesthatintegratesinformationfromsectionsintheQualityModuleandsupportinginformationfromotherModules(e.g.qualificationofimpuritiesviatoxicologicalstudiesdiscussedundertheCTD-Smodule),includingcross-referencingtovolumeandpagenumberinotherModules.
ThisQOSnormallyshouldnotexceed40pagesoftext,excludingtablesandfigures.Forbiotechproductsandproductsmanufacturedusingmorecomplexprocesses,thedocumentcouldbelongerbutnormallyshouldnotexceed80pagesoftext(excludingtablesandfigures).
Theitalicisedtextbelowindicateswheretables,figures,orotheritemscanbeimporteddirectlyfromModule3.
INTRODUCTION
Theintroductionshouldincludeproprietaryname,non-proprietarynameorcommonnameofthedrugsubstance,companyname,dosageform(s),strength(s),routeofadministration,andproposedindication(s).
2.3.SDRUGSUBSTANCE(NAME,MANUFACTURER)
2.3.S.1GeneralInformation(name,manufacturer)
Informationfrom3.2.S.1shouldbeincluded.
2.3.S.2Manufacture(name,manufacturer)
Informationfrom3.2.S.2shouldbeincluded:
∙Informationonthemanufacturer;
∙Abriefdescriptionofthemanufacturingprocess(including,forexample,referencetostartingmaterials,criticalsteps,andreprocessing)andthecontrolsthatareintendedtoresultintheroutineandconsistentproductionofmaterial(s)ofappropriatequality;
∙Aflowdiagram,asprovidedin3.2.S.2.2;
∙AdescriptionoftheSourceandStartingMaterialandrawmaterialsofbiologicaloriginusedinthemanufactureofthedrugsubstance,asdescribedin3.2.S.2.3;
∙Adiscussionoftheselectionandjustificationofcriticalmanufacturingsteps,processcontrols,andacceptancecriteria.Highlightcriticalprocessintermediates,asdescribedin3.2.S.2.4;
∙Adescriptionofprocessvalidationand/orevaluation,asdescribedin3.2.S.2.5.
∙Abriefsummaryofmajormanufacturingchangesmadethroughoutdevelopmentandconclusionsfromtheassessmentusedtoevaluateproductconsistency,asdescribedin3.2.S.2.6.TheQOSshouldalsocross-refertothenon-clinicalandclinicalstudiesthatusedbatchesaffectedbythesemanufacturingchanges,asprovidedintheCT