Q10 Quality system.pdf

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1、GuidanceforIndustryQ10PharmaceuticalQualitySystemU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)April2009ICHGuidanceforIndustryQ10PharmaceuticalQualitySystemAdditionalc

2、opiesareavailablefrom:OfficeofCommunicationDivisionofDrugInformationCenterforDrugEvaluationandResearchFoodandDrugAdministration10903NewHampshireAve.,Bldg.51,Room2201SilverSpring,MD20993-0002(Tel)301-796-3400http://www.fda.gov/cder/guidance/index.htmOfficeofCommunicatio

3、n,OutreachandDevelopment,HFM-40CenterforBiologicsEvaluationandResearchFoodandDrugAdministration1401RockvillePike,Rockville,MD20852-1448(Tel)1-800-835-4709or301-827-1800http://www.fda.gov/cber/guidelines.htm.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministratio

4、nCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)April2009ICHTABLEOFCONTENTSI.INTRODUCTION(1,1.1)................................................................................................1II.PHARMACEUTICALQUALITYMANAGEMENTSYST

5、EM.................................2A.Scope(1.2).......................................................................................................................................2B.RelationshipofICHQ10toRegionalGMPRequirements,ISOStandards,andICHQ7(1.3)...........

6、.................................................................................................................3C.RelationshipofICHQ10toRegulatoryApproaches(1.4).........................................................3D.ICHQ10Objectives(1.5).........................

7、.....................................................................................3E.Enablers:KnowledgeManagementandQualityRiskManagement(1.6)...............................4F.DesignandContentConsiderations(1.7).......................................................

8、.............................4G.QualityManual(1.8)...................................................................