项目验证管理及质量管理

《项目验证管理及质量管理》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、EngineeringValidationManagementforPharmaceuticalProject制药工程项目验证管理徐文勤ValidationMode-ISPE“V”Mode常见的验证模式-ISPE“V”型确认模式URSPQTestPlan测试计划PQ用户需求性能确认FunctionDesignOQTestPlan测试计划OQ功能设计运行确认DetailDesignIQIQTestPlan详细设计安装确认测试计划Implement执行ValidationMode-ASTME2500Mode常见的验证模式-ASTME2500模式Focus

2、edonproduct/processandRequirementregulatory/PQSrequirementsDocumentonlyRequirementsURSEngineeringDocumentforuserDesignandotherrequirementsBasis(i.e.EHS)IdentificationofImpactVQSMatrixVerificationQualityStrategy:CriticalAspectsAssessment&DesignReviewScience/Riskbasedapproachbase

3、donrequirementdocumentanddesignreviewVerificationTestingisasingleGEPTestingCommissioningTestingactivity-coveringCommissioning,SAT/FAT/IOQIOQClose-outPCQPIOQSystemReportsAcceptance&Singleclose-outreportClose-outReportreleasereportforsystemValidationCooperation验证各相关方的协作Owner’sRe

4、sponsibilities业主方的工作重点BuildValidationmanagementsystembasedonGMPqualitysystem建立基于GMP质量管理体系框架的验证管理体系ProjectflexibilitystudyandissueURS评估项目的可行性并出具用户需求文件ImpactAssessment,includeprocessandsystem影响因素评估,包括工艺及系统PrepareValidationMasterPlan(VMP)验证主计划的制定Involveinqualificationactiviti

5、es,fromDQtoOQ从设计确认到运行确认的全过程参与PQactivities性能确认活动SupplementedValidationActivities,suchasPV,CV,CSV后续的验证活动，如工艺验证、清洁验证、计算机验证ValidationCooperation验证各相关方的协作Contractor’sResponsibilities项目总承包方的工作重点BuildValidationmanagementsystembasedonProjectQMS建立基于项目质量管理体系的验证管理体系PrepareSpecificati

6、onbasedonowner’sURS根据业主的用户需求准备规格说明书ImpactAssessment,includeprocessandsystem影响因素评估,包括工艺及系统PrepareProjectQualificationMasterPlanalignwithowner’sVMP根据验证主计划（VMP）准备项目确认主计划（PQMP）Vendorevaluation(validationexecutioncapability)供应商评估（验证活动的执行能力）DQforCriticalsystemsandprocessequipment

7、s重要设施及重要工艺设备的设计确认（DQ）RiskAnalysis风险分析IOQforCriticalsystemsandprocessequipments重要设施及重要工艺设备的安装、运行确认（IOQ）FAT/SAT/CommissioningValidationCooperation验证各相关方的协作System/equipmentvendor’sresponsibilities设备/系统供应商的工作重点PrepareandexecuteFAT/SAT/CommissioningPlans完善出厂接受测试、现场接受测试、调试计划并执行

8、ParticipateinIOQactivitiesandpreparedocument参与安装运行确认活动