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,ponentsintheformulation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,包括对卷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量量差异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②AcquiringAPIandrelatedimpurityrefereneestandards(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(anyattributes①QualificationofAPIandexcipientssuppliers,includingauditingandfulltestingonthreedifferentlots原料药和辅料供应商的资格认证