[高效管理]FDA药品批准程序简介.pptVIP

System Based Current Good Manufacturing Practice (CGMP) 基于CGMP的系统 Quality System （质量管理系统） Material System （原材料系统） Facilities and Equipment System （生产设施和设备系统） Production System （生产系统) Packaging and Labeling System （包装和标记系统） Laboratory Control System （实验室控制系统） DMF PreparationDMF文件的准备 I. Conventional Format 传统形式 - Accepted by FDA 被FDA所认可 II. The CTD-Format (Module 3) CTD形式（模板3） - Accepted,Not Required by FDA FDA认可，但没有要求 - Accepted by EU 欧盟认可 Drug Substance (API)原料药（API） Starting Material原材料 - Define starting materials and their specifications 确定原材料及其规格 Process Control and Critical Parameters 工艺控制和关键参数 - Identifying critical process parameters 识别关键工艺参数 - In-process testing and acceptance criteria在线测试和验收标准 Characterization of DS DS描述 - Structure elucidation, physicochemical properties 结构说明，物理化学特性 Impurity Profile杂质分布图 - Identification, qualification, limits 识别、确认、限度 Drug Substance (API)原料药（API） Specifications 规范 - Acceptance criteria, justifications 验收标准，符合要求 Method Validation 方法验证 - Validations and/or verifications 验证和/或确认 Reference Standard 参考标准 - Characterization 特征说明 Stability Study 稳定性研究 - Stability-indicating methods, retest date 稳定性指示方法，重新测试日期 Summary总结 Presented a brief description of the drug review process from CMC perspective. 从CMC角度简单说明了药品审核程序 Discussion on drug substance (API) section of drug application (DMF). 讨论了药品申请(DMF）中的原料药部分 Providing adequate CMC information in the application is very important. 在申请中提供足够的CMC信息是很重要的 。 随时欢迎客户的任何新的和更深入的探讨 谢 谢！ * 1. Research and Development (New Chemical Entity) - DS development (organic synthesis, natural product, screening, etc.) 2. Pre-clinical Studies - Physical and chemical properties studies, pre-formulation - Biological activities - 3. Investigational New Drug Application (IND) - 30 days safety review Clinical Trials (Phase I, II, III), Including studies on: - Lo