美国FDA无菌原料药验证要求.ppt

Intl Reg Bus Cons 09validnsfda1 U.S. FDA Requirements for Validation of Sterile APIs美国FDA无菌原料药验证要求 Beijing, ChinaSeptember 25-26, 2004 Presentation by Ira R. Berry International Regulatory Business Consultants, L.L.C. Maplewood, New Jersey, USA Workshop Format 目录 Part I – Requirements for cGMP Compliance （cGMP相关要求） Part II – U.S. FDA cGMP Guidance for APIs 美国FDA原料药cGMP指南 Part III – Basic Validation Requirements 验证的基本要求 Part IV – cGMP for Sterile Drug Products and APIs 无菌药品和原料药cGMP Comply with cGMP 实施cGMP Quality assurance program 质量保证 Standard Operating Procedures (SOPs) Personnel training 人员培训 In-house audits 内部审计 Standard Operating Procedures (SOP) Quality system 质量系统 Calibration 校验 OOS investigations OOS调查 Process deviations 工艺偏差 Stability program 稳定性试验 Personnel training 人员培训 Internal audits 内部审计 Recalls 召回 Documentation control 文件控制 Validation and qualification 验证和确认 Cleaning 清洗 Maintenance 维护 Personnel responsibilities 人员职责 Warehousing 仓储 Distribution 发放 Validation Basics 基本验证 Facility qualification 设施确认 Equipment/instrument qualification 设备/仪器确认 Raw materials qualification 原料确认 Analytical methods validation 分析方法验证 Cleaning validation 清洗验证 Process validation 工艺验证 Specifications 规格 Raw materials 原料 Packaging components 包装材料 In-process tests and specifications 过程控制和规格 Finished product tests and specifications 成品检验和规格 Change Control 变更控制 Technology transfer 技术转让 Site change 地址变更 Equipment change 设备变更 Scale change生产规模变更 Specification (parameter/allowable range/method) change规格（参数/允许范围/方法）变更 Process change 工艺变更 Product Registrations: Drug Master Files and NDAs/ANDAs 产品注册：DMF和（简略）新药申请 Create a document that is question-free建立好的文件－不要有问题 Anticipate questions – prepare 预料到的问题－做好准备 Be responsive 快速反应 Prepare for Regulatory Inspections准备认证检查 Systems-based drug inspection approach: 药品系统检查涉及： Quality 质量 Facilities and Equipment 设施和设备 Materials 物料 Production 生产 Packaging and Labeli