Q10 药物质量体系20080604(中英文)

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1、Q10药物质量体系20080604（中英文）    INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEICH三方协调指南PHARMACEUTICALQUALITYSYSTEM药物质量体系Q10CurrentStep4versiondated4June2008ThisGuidelinehasbeend

2、evelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA. Q10DocumentHistory文件历史C

3、odeHistoryDateQ10ApprovedbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.9May2007CurrentStep4versionCodeHistoryDateQ10ApprovedbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.4June2008  PHARMACEUTICALQUAL

4、ITYSYSTEMICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon4June2008,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICHTABLEOFCONTENTS1.PHARMACEUTICALQUALITYSYSTEM..............................

5、............................11.1Introduction................................................................................................................11.2Scope................................................................................................

6、..........................11.3RelationshipofICHQ10toRegionalGMPRequirements,ISOStandardsandICHQ7.............21.4RelationshipofICHQ10toRegulatoryApproaches................................................21.5ICHQ10Objectives......................................

7、..............................................................21.5.1AchieveProductRealisation..........................................................................21.5.2EstablishandMaintainaStateofControl...................................................31

8、.5.3FacilitateContinualImprovement.................................................................31.6Enablers:KnowledgeManagementandQualityRiskManagement..................