gmp风险管理在制药企业原辅料供应商管理中的应用

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1、上海交通大学工程硕士学位论文符号说明ARisk-BasedApproachforManagementofRawMaterialSuppliersinPharmaceuticalIndustryABSTRACTRiskmanagementhasbeenemployedinpharmaceuticalindustryinrecentyears.Risk–basedapproachformanagementofrawmaterialsuppliershasbeenacrucialaspectinqualitymanagementsystem.Thisthesisprovidesanover

2、viewofregulatoryrequirementandmethodologiesofqualityriskmanagementinrawmaterialmanagement.Acasestudy,usingPfizerasanexample,ofapplyingarisk-basedapproachformanagementofrawmaterialsuppliersinpharmaceuticalindustrywasdiscussedincludingtheriskmanagementtheory,methodologyandanalysistoidentify,evalu

3、ate,andcontrol/reducetherisksinanacceptablelevel.Aquantitativeriskassessmentwasconductedtoidentifypotentialrisksofsuppliertodemonstratethesupplychainsecuritiesaswellaspatientsafetyaftertheimplementationofappropriateriskmitigations.Furthermore,therisk-basedapproachfacilitatesresourcesplanningand

4、allocationbyfocusingonthesupplierswithhighrisk,thereforeimprovesmanagementefficiency.Thisthesisprovidespharmaceuticalindustryaclearinstructiononrisk-basedqualitymanagementinrawmaterialsuppliers,whichisacriticalstepinensuringfinalproduct(marketdrug)safety.Followingregulatoryguidelinesandthrougha

5、nalysisofriskassessment,manufacturerswillbeabletounderstandbetterintermsofwhereishighriskarea,thereforesetupprocedurestominimizetherisksandensurefinalproductsafety.KEYWORDS:GMP,QualityRiskManagement,SupplierManagementII万方数据上海交通大学工程硕士学位论文符号说明符号说明AbbreviationsFullspellingChineseexplanation缩略语英文全名

6、中文解释cGMPCurrentGoodManufacturePractice现行良好生产规范EMAEuropeanMedicinesAgency欧洲药品管理局FDAFoodandDrugAdministration美国食品药品监督管理局GMPGoodManufacturePractice良好生产规范ICHinternationalconferenceonharmonization国际协调会议MedicinesandHealthcareproductsMHRA英国药品管理局RegulatoryAgencyWHOWorldHealthOrganization世界卫生组织SOPStanda

7、rdOperationProcedure标准操作程序★注：在此缩略语按字母顺序排列，并非按文中出现顺序排列。III万方数据上海交通大学工程硕士学位论文目录目录摘要..................................................................IABSTRACT..............................................................II符号说明......