研发流程与QbD简介DS.ppt

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1、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,

2、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,20094法规符合WhatisQualitybyDesign?什么是质量源于设计(Reference:ICHQ8(R2),2009)SystematicapproachtodevelopmentBeginswithpredefinedobjectives

3、EmphasizesproductandprocessunderstandingandprocesscontrolBasedonsoundscienceandqualityriskmanagement(ICHQ9)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Reduceproductvariabilityanddetectsbyincreas

4、ingproductandprocessunderstanding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7QbDTerminologyQualityTargetProductProfile目标产品质量概况CriticalQualityAttributes关键质量属性CriticalMaterialAttribute

5、s关键物料属性CriticalProcessParameters关键工艺参数RiskAssessment风险评估DesignSpace设计空间ControlStrategy控制策略ContinualImprovement继续改进SystematicApproachbyQbDPredefinedObjective预定的目标DefinedQualityTargetProductProfile(QTPP)IdentifyCriticalQualityAttributes(CQA)ProductandProcessUnderstanding对产品和工艺的理

6、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LiteraturePriorknowledge

7、DevelopmentstudyQualityRiskManagement质量风险管理Riskbasedapproachthroughdevelopmenttocommercialmanufacturing,aswellascontinualimprovementOverviewofQbD质量源于设计的概括QualityTargetProductProfile(QTPP)产品质量概括CriticalQualityAttributes(CQA)关键质量属性ProductDesignandProcessUnderstanding(CMA,CPP)Con

8、trolStrategy(PAR,OR.Etc.)ContinualImprovement法规符合ProcessCompa