ICHQ9-质量风险管理(中英文)

ICHDraftConsensusGuidelineQ9QualityRiskManagementQ9ICH2005322ICHICHICHICHICHICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPageiJune6,2005ICH20053221.12.13.24.24.134.234.334.444.554.655.55.165.265.365.4HAZOP75.5(FMEA)75.6FMECA85.7FTA85.8PHA85.995.1096.107.118.13AnnexI:141.1141.2141.3151.416ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPageiiJune6,20051.5171.6181.7181.8181.919ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage1June6,20051.(Stakeholder)StakeholderICH2.ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage2June6,2005/3.4.11/ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage3June6,2005Decisionnode4.14.2/4.35123ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage4June6,2005uncertainty010%100%4.4/1234ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage5June6,20054.54.6(4.4)5.(4)FMEAFMECAFTAHACCPICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage6June6,2005HAZOPPHA5.15.25.3HACCPWHO908,20037HACCP7123ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage7June6,2005456HACCP7HACCPHACCP5.4HAZOPHAZOPHAZOPHAZOPHACCPHAZOP5.5(FMEA)FMEAIEC60812/FMEAFMEAFMEAICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage8June6,20055.6FMECAFMEAFMEAFMECAIEC60812FMECAFMECAFMECA5.7FTAIEC61025FTAAND,ORFTAFTA5.8PHA(PHA)1ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage9June6,200523PHAPHAPHA5.9weightingfactorcut-off5.10ISO7966ISO7873ISO7871ISO8258DOEICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage10June6,20056.I5IIIICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage11June6,2005I7.Harm:Hazard:ISO/IECGuide51.ProductLifecycle:Quality:QualityRiskManagement:QualitySystem:Requirements:Risk:harm(ISO/IECGuide51)RiskAcceptance:ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage12June6,2005ISOGuide73RiskAnalysis:(theidentifiedhazard)RiskAssessment:RiskCommunication:stakeholderRiskControl:ISOGuide73.RiskEvaluation:RiskIdentification:RiskManagement:RiskReduction:harmRiskReview:Severity:Stakeholder:Trend:ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage13June6,2005Uncertainty:8.ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage14June6,200511.1SOPOOS/ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage15June6,2005//1.2I.1/PAT1.3VSICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage16June6,20051.4/HVAC//ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage17June6,2005/VSVS/1.5ICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage18June6,20051.6(parametricrelease)(real-timerelease)PAT1.7ICHOOSOOS/1.8secondarypackageICHDraftConsensusGuidelineQ9QualityRiskManagementPreparedandtranslatedbyHUKaiPage19June6,20051.9continuousimprovementSupplement/Variation(Ifapplicable)RegulatorysubmissionCustomerSatisfactionCustomerRequirementsDefineManufactureDesignQualityRiskManagementTechnologyTransferChangeControlPeriodicReviewPharmaceuticalDevelopmentINTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEQUALITYRISKMANAGEMENTQ9CurrentStep4versiondated9November2005ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.Q9DocumentHistoryFirstCodificationHistoryDateNewCodificationNovember2005Q9ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.22March2005Q9Q9ApprovalbytheSteeringCommitteeofPostStep2correction15June2005Q9CurrentStep4versionQ9ApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.9November2005Q9QUALITYRISKMANAGEMENTICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon9November2005,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICHTABLEOFCONTENTS1.INTRODUCTION................................................................................................12.SCOPE..................................................................................................................23.PRINCIPLESOFQUALITYRISKMANAGEMENT....................................24.GENERALQUALITYRISKMANAGEMENTPROCESS............................24.1Responsibilities..................................................................................................................34.2InitiatingaQualityRiskManagementProcess...............................................................34.3RiskAssessment