ICH 检查内容.doc

AGENDA议程Comprehensive review with reference to FDAs “six system” Compliance Program Manual:与FDA”六体系”顺应性程序手册相关的综合检查Quality System - This system assures overall compliance with cGMPs and internal procedures (SOPs) and specifications.质量体系-系统确保要与cGMPs，SOPs，及质量标准有总的顺应性a) FDA Compliance HistoryFDA顺应性历史b) Quality Control Unit and all of its review and approval duties, including:质量控制部分和所有的回顾及批准职责，包括：i) Change Control （变化控制）(1) Changes to DMF or Application DMF变更及申报ii) Reprocessing 返工iii) Batch Release 批放行iv) Annual Record Review 年记录回顾v) Validation Protocols and Reports 验证计划、方案和报告vi) Product Defect Evaluations 产品缺陷回顾(1) Complaint File 投诉档案vii) Returned and Salvaged Goods Evaluation 产品退货及回收评估viii) Table of Organization 组织机构图ix) Curricula Vitae of Key Personnel 关键人员履历书x) SOP Index SOP索引xi) Training Program 培训计划xii) Internal Audit Program 内部审计程序xiii) Vendor Qualification Program 客户确认程序(1) Vendor Audits 客户审计Facilities and Equipment System - This system includes the measures and activities which provide an appropriate physical environment and resources used in the production of APIs.设备和仪器系统-系统包括（提供API产品所需的适当的自然环境和资源的）措施和活动c) Buildings and Facilities 厂房和设施i) General Tour 总体布局ii) Map / Floor Plan of Plant Layout 工厂平面布置图 iii) Maintenance 维护iv) Qualification 确认v) Monitoring 监控d) Equipment 设备（仪器）i) Qualification (Installation, Operation) 确认（安装和运行）(1) Note: Performance Qualification to be evaluated as part of Process Validation (see Production System below).注：性能确认评估作为工艺验证的一部分ii) Calibration 校验iii) Preventative Maintenance Program 维护保养计划iv) Cleaning 清洁v) Validation of Cleaning Processes, as appropriate清洗程序适应性验证vi) Use Logs 仪器设备使用纪录e) Utilities that are not intended to be incorporated into the product公用设施i) HVAC 空调净化系统ii) Compressed Gases 压缩气体iii) Steam 蒸汽iv) Water Systems 水系统(1) Validation 验证(2) Routine Monitoring 常规监测(a) Chemical Purity 化学纯度(b) Microbial Purity 微生物纯度Materials System - This system includes measures and activities to control物料系统-系统包括措施和行为控制f) Finished Products 成品g) Components of the product, including 产品组件，包括i) containers 容器 ii) closures 包装iii) water 水iv) gases 气体h) Raw Material Retest Program 原料的再检验程序i) Validation of Computerized Inventory Control Processes计算机存货系统的控制程序j) Drug Storage 药品贮存i) Temperature / Humidity Mapping and Monitoring温度湿度图表和监控ii) Bulk Holding Times Studies 贮存时间研究k) Distribution Controls 发放控制l) Reserve Sample Program 留样计划m) Records 记录Production Systems - This includes measures and activities to control the manufacture of APIs, including: 生产系统-控制API生产的程序和措施n) Batch Compounding 混批 i) Process Flow Charts 工艺流程图o) In-process Sampling and Testing 中间取样和检验p) Process Validation 工艺验证q) Solvent Recovery 溶剂回收r) Approved, Written Manufacturing Procedures 工艺规程的起草和批准程序i) Establishment of 起草ii) Following of 审核批准iii) Documenting performance of 文件执行Packaging and Labeling System - This system includes measures and activities that control the packaging and labeling. It includes:包装和标签体系-包括控制包装和标签的措施和行为的系统s) Written procedures 书面程序t) Label Examination and Usage 标签检查和使用u) Label Storage and Issuance 标签贮存和发放v) Packaging and labeling Operations Controls 包装和标签的操作控制w) Validation of these operations 操作验证？x) Lot numbering system 批号编制Laboratory Control System - This system includes measures and activities related to化验室控制体系x) Laboratory procedures 化验室操作程序i) SOP for Investigation of Out of Specification (OOS) ResultsOOS调查的SOPy) Analyst Training Program 分析操作技能培训计划z) Testing and Test Records 检测及实验记录aa) i) Incoming Raw Materials 新进原材料ii) Intermediates 中间体iii) Finished Products 成品iv) Residual Solvents 残留溶剂v) Lab Notebooks - bound or loose sheets 实验记录装订记录（批检验记录等）及零散记录bb) Analytical Methodology 分析方法i) Development 开发ii) Validation or Verification 验证cc) Lab Equipment 实验室设备（仪器）i) Qualification 确认ii) Maintenance contracts 维护iii) Calibration 校验iv) Use Logs 设备使用纪录dd) Stability Program 稳定性程序i) ICH Storage Requirements ICH贮存要求(1) Chamber qual