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，生产和控制CGMPCompliancetoMeetRegulatoryRequirements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，获取有关该对照药物的基本信息①Componentsintheformulation处方成份②BEinformation生物等效性信息③Etc.其它2ReverseEngineeringStudy,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①Potency/purity效价/纯度②Impurityprofile(relatedsubstances)③杂质分布曲线图（相关物质）④Contentuniformity含量均匀度⑤Weightvariation重量差异⑥Dissolutionprofile溶出曲线⑦Disintegrationtime崩解时间⑧HardnessandFriability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①Analyticalmethoddevelopment分析方法发展(DevelopadequateanalyticalmethodsforAPI)针对原料药发展合适的分析方法②AcquiringAPIandrelatedimpurityreferencestandards(USPorothersources)获得原料药和相关杂质参考标准（美国药典或其他来源）③APIcharacterizationandqualification,includingchemicalandphysicalpropertiesstudies,suchassolubility,density,particlesizedistribution,polymorphism(anyattributesrelevanttotheformulation)原料药的特性和认证，包括理化特征研究，如：溶出度，密度，颗粒粒径分布，多态现象（任何与处方相关的属性）①QualificationofAPIandexcipientssuppliers,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。②EstablishacceptancecriteriaforAPIandexcipientsandcorrespondinganalyticalmethods建立可接受的原料药及辅料标准和相应的分析方法③Validationorverificationoftheseanalyticalmethods这些分析方法的验证和确认。④Preparationofpre-formulationstudyreportorsummaryfromCGMPperspective从现行GMP的角度，准备处方前研究报告或概括总结④Excipientsspecifications(acceptancecriteriaandtestingmethodstomeetUSP/NFstandards),andexcipientscharacterizationandqualification,includingcompatibilitystudieswithAPI.辅料的技术规范（符合USP和NF标准的可接受标准和测试方法）辅料特性认证，包括与原料药的相容性研究4FormulationDevelopment处方开发①Formulationselection(componentsandcomposition)basedonRLDformulationandin-housestudy.处方筛选（组成成份）以对照药物配方和室内研究为基础）②Defineinitialprocess(platform)forpreparationofprototypegenericdrugproduct(DP),阐述制备仿制药的原型产品（DP）的初始过程（平台）③DefinetheinitialspecificationsforDP,includinglogoandnumberartworkpreparationonthesurfaceofthedrugproduct.阐述药品的初始规范，包括药品表面上的标识，数字或图形的安排。④Produceone(ormore)smallresearchanddevelopmentDPbatchandtesttheproductaccordingtofinishedproductspecifications,includingtheevaluationofDPimpurityprofileandperformdissolutionprofilestudycomparedwiththeRLDproduct.生产一小批经研究开发的药品，并根据制成品规范对其进行测试，这包括药品杂质分布评估，和对照药物进行比对，进行溶出曲线研究。⑤PlacetheDPonacceleratedstabilitystudy(upto3months)toevaluatethestabilityoftheformulationdeveloped.对药品...
