研发流程与QbD简介DS.pptVIP

****原料药工艺研发流程与QbD

技术转化为价值

GMP–医药化工法规约束

稳定的工艺–实施GMP的基础

QbD(质量源于设计）-工艺开发指导

法规符合QualitybyDesign

质量源于设计–前控制

质量源于生产–过程控制

质量源于检测–后控制

法规符合*QualitybyDesign

质量源于设计Definition定义Systematicapproachtodevelopmentthatbeginswithpredefinedobjectivesandemphasizesproductandprocessunderstandingandprocesscontrol,basedonsoundscienceandqualityriskmanagement.以合理的科学和质量风险管理为依据的，起始于预定的质量目标，注重对产品和工艺的理解以及对生产工艺过程控制的系统的研发方法 Reference:ICHQ8(R)(2)PharmaceuticalDevelopment,2009法规符合WhatisQualitybyDesign?

什么是质量源于设计

(Reference:ICHQ8(R2),2009)法规符合GoalsofImplementingQbD

应用质量源于设计的目的Achievemeaningfulproductspecificationsthatarebasedonclinicalperformance. 根据临床需求建立有意义的产品质量标准Reduceproductvariabilityanddetectsbyincreasingproductandprocessunderstanding通过对产品和其工艺的理解，减少产品质量的变异和瑕疵Enhanceproductdevelopmentandmanufacturingefficiencies提高产品开发和生产效率Improvepost-approvalchangemanagement改善和方便批准后更改的管理*QbDTerminologyQualityTargetProductProfile目标产品质量概况添加标题CriticalQualityAttributes关键质量属性添加标题CriticalMaterialAttributes关键物料属性添加标题CriticalProcessParameters关键工艺参数添加标题RiskAssessment风险评估添加标题DesignSpace设计空间添加标题ControlStrategy控制策略添加标题ContinualImprovement继续改进添加标题SystematicApproachbyQbDPredefinedObjective预定的目标DefinedQualityTargetProductProfile(QTPP)IdentifyCriticalQualityAttributes(CQA)ProductandProcessUnderstanding对产品和工艺的理解DefineCriticalMaterialAttributes(CMA)IdentifyCriticalProcessparameters(CPP)UnderstandingtherelationshipbetweenCMA,CPPandCQAProcessControl生产工艺过程控制EstablishappropriatecontrolstrategyDefineProvenAcceptableRange(PAR)andOperationalRange(OR)SoundScience合理的科学LiteraturePriorknowledgeDevelopmentstudyQualityRiskManagement质量风险管理Riskbasedapproachthroughdevelopmenttocommercialmanufacturing,aswellascontinualimprovementOverviewofQbD

质量源于设计的概括法规符合*ProcessComparison工艺比较1QbDConceptA