固体制剂仿制药研发流程.doc

文档介绍：GenericDrugProductDevelopmentStages仿制药发展阶段(OralSolidDosageForms,Tablets)(口服固体制剂,片剂)StageChemistry,Manufacturing&ControlsinOralSolidDosageFormDevelopment口服固体制剂发展中的化学特性,pliancetoMeetRegulatoryRequirements满足法规要求的CGMP规范1DrugPackagingInsertStudytoobtainbasicinformationaboutRLD,suchas通过对对照药物的包材以内成分的分析,,includingevaluationofthreedifferentlotsofRLDfor:根据前述研究采用倒推法研究制剂工艺,包括对叁批不同批次对照药物的评估Potency/purity效价/纯度Impurityprofile(relatedsubstances)杂质分布曲线图(相关物质)Contentuniformity含量均匀度Weightvariation重量差异Dissolutionprofile溶出曲线Disintegrationtime崩解时间HardnessandFriability硬度和脆碎度SystembasedCGMPauditingonmanufacturingfacility:①QualitySystem②MaterialsSystem③FacilitiesandEquipmentSystem④ProductionSystem⑤PackagingandLabelingSystem⑥LaboratoryControlSystem对生产设施进行基于系统的CGMP审计①质量系统②物料系统③设施设备系统④生产系统⑤包装和标签系统⑥实验室控制系统3Pre-formulationStudies处方前研究Analyticalmethoddevelopment分析方法发展(DevelopadequateanalyticalmethodsforAPI)针对原料药发展合适的分析方法AcquiringAPIandrelatedimpurityreferencestandards(USPorothersources)获得原料药和相关杂质参考标准(美国药典或其他来源)APIcharacterizationandqualification,includingchemicalandphysicalpropertiesstudies,suchassolubility,density,particlesizedistribution,polymorphism(anyattributesrelevanttotheformulation)QualificationofAPIandexcipientssuppliers,includingauditingandfulltestingonthreedifferentlots原料药和辅料供应商的资格认证,包括审计和对三种不同批次进行的全面测试。eptancecriteriafor