产品DMF列表模板.doc

封皮格式）DRUG MASTER FILECTD FORMAT 品名IP/CPDOCUMENT APPROVALS.No.DescriptionNameDesignationSignatureDate1.Prepared By填写填写最终确认好的英文稿打印后手签字2.Reviewed By3.Approved By******* Pharmaceutical Co., Ltd.　公司英文名称〔Headquarter Address〕总部地址******〔Factory Address〕生产厂址**************Drug SubstanceGeneral Information Nomenclature命名Structure 结构 分子式 分子量General Properties 溶解性 外观等物理特性、包括超干粉特殊特性ManufactureManufacturer公司名称地址邮编联系人和联系方式Description of Manufacturing Process and Process Controls生产工艺描述（含工艺控制和批量范围）Control of Materials原材料列表（起始原料合格供应商名单）各原材料质量标准Control of Critical Steps And Intermediate各步骤主要工艺控制范围中间体质量标准Process Validation And /or Evaluation工艺验证简述Manufacturing Process Development工艺研发历史CharacterisationElucidation of The Structure And Other Characteristics 提供红外 紫外 核磁 质谱 结构确证资料含图谱Impurities本品各杂质控制标准Residual Solvent工艺中用到的有机残留溶媒控制标准和有机残留溶媒分析方法Control of Drug SubstanceSpecification分别列出IP2014 CP质量标准(IP标准需要包括溶解性)Analytical Procedure3.2.S.4.2.1 Analytical procedure as per IP3.2.S.4.2.2 Analytical procedure as per CP分别给出IP2014 CP标准对应的产品分析方法Validation of the Analytical ProcedureIP2014 CP标准分析方法验证和代表性图谱如果日常放行检验残留溶媒，请附上残留溶媒分析方法验证Batch Analysis提供本品批号编制原则批量上限值连续五批COA（每批分别出具IP、CP标准质检单）和批分析数据汇总表Justification of Specification标准评价Reference Standards or Materials日常检测用对照品或工作对作品信息/标定/储存和销毁管理简述Container Closure System本章节需要给出包装模式描述、内外包材质量标准、出口印度专用标签图片，另外还要单独提供3份不干胶标签样张标签内容至少包括：公司标识品名 IP Batch No.:Manufacturing Date:Expiry Date:Gross Weight:Net Weight:Manufacturer: **Manufacturer Address: 同GMP英文地址一致Country of Origin: CHINA.Manufacturing License No.:Storage condition: ***Import License No.: Importer Name: Importer Address: (因客户地址名称很长，通常后面预留至少３行空地)StabilityStability Summary and Conclusion需要说明申请的产品有效期（至少需要３年）。

产品有效期将写入注册证Post Approval Stability Protocol and Stability CommitmentStability Data 　（请按照附件格式提供）3.2.S.7.4 Forced degradation study　（高温高湿光照）AppendicesFacilities and equipments　主要设备和仪器列表TES/BSE StatementMaterial Safety Data Sheet (MSDS) Annual Quality Review (2012 and 2013) 过去两年年度质量回顾(只需要综述)附：稳定性数据格式加速考察数据（3批; 格式如下）ACCELERATED (SHORT TERM) STABILITY STUDIES Drug Name: Batch No.:批号Mfg. Date 生产日期: Batch size: 批量Package 样品包装模式: Date of Initial analysis: 初检验日期Temperature: 40 oC±2oC Relative Humidity: 75%±5%Specification:CPTest ItemsSpecificationsResults (Test data)Initial1Month2Months3Months6MonthsConclusion: The all parameter meets the standards and complies in specified limits upon the storage of specified conditions.Prepared By: Checked By长期考察数据（3批，批号同加速考察批次相同）REAL (LONG TERM) STABILITY STUDIESDrug Name: Batch No.:批号Mfg. Date 生产日期: Batch size: 批量Package 样品包装模式: Date of Initial analysis: 初检验日期Temperature: 25 oC±2oC Relative Humidity: 60%±5%Specification: CPTest ItemsSpecificationsResults (Test data)Initial3Months6Months9Months12Months18Months24Months36Months48MonthsConclusion: The all parameter meets the standards and complies in specified limits upon the storage of specified conditions.Prepared By: Checked By。