ICH 检查内容.docVIP

AGENDA 议程 Comprehensive review with reference to FDA’s “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 FDA Compliance History FDA顺应性历史 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： Change Control （变化控制） Changes to DMF or Application DMF变更及申报 Reprocessing 返工 Batch Release 批放行 Annual Record Review 年记录回顾 Validation Protocols and Reports 验证计划、方案和报告 Product Defect Evaluations 产品缺陷回顾 Complaint File 投诉档案 Returned and Salvaged Goods Evaluation 产品退货及回收评估 Table of Organization 组织机构图 Curricula Vitae of Key Personnel 关键人员履历书 SOP Index SOP索引 Training Program 培训计划 Internal Audit Program 内部审计程序 Vendor Qualification Program 客户确认程序 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 API’s. 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 Buildings and Facilities 厂房和设施 General Tour 总体布局 Map / Floor Plan of Plant Layout 工厂平面布置图 Maintenance 维护 Qualification 确认 Monitoring 监控 Equipm