FDA认证检查的6大系统.docx

1 QUALITY SYSTEM质量保证系统 1.1 Product reviews (annual) 产品审查(年度) 1.2 Complaint reviews (quality and medical) 投诉审查(质量和医疗) 1.3 Discrepancy and failure investigations 不一致和失败的调查 1.4 Document Control 文件控制 1.5 Batch release 批放行 1.6 Change Control变更控制 1.7 Reprocess/Rework再加工/返工 1.8 Returns/Salvages 退回/补救 1.9 Rejects 拒收 1.10 Stability Failures稳定性失败 1.11 Quarantine 待验 1.12 Validation: computer, equipment, process, laboratory methods, cleaning 验证：计算机、设备、工艺、实验方法、清洁 1.13 Training/qualification 培训/资质 1.14 internal Audit Program内审规程 1.15 Supplier Audit Program 供应商审计规程 2 FACILITIES AND EQUIPMENT SYSTEM 厂房设施与设备系统 I Facilities 厂房设施 2.1 cleaning and maintenance 清洁与维护保养 2.2 facility layout and air handling systems厂房设施布局与空气处理系统 2.3 general air handling systems 全面的空气处理系统 2.4 control system for implementing changes in the building实施在厂房方面变更的控制系统 2.5 purified water and compressed air systems纯化水与压缩空气系统 2.6 lighting, potable water, washing and toilet facilities, sewage and refuse -disposal照明、饮用水、清洗和盥洗设施、污水及垃圾处理 2.7 sanitation of the building, use of rodenticides, fungicides, insecticides, cleaning and sanitizing agents厂房卫生、灭鼠剂、杀真菌剂、杀虫剂、清洗剂及消毒剂的使用 2.8 drawings (as built) 布局图(厂房) II Equipment 设备 ? equipment installation and operational qualification设备安装和运行确认 ? adequacy of equipment design, size, material, construction and location 适当的设备设计、大小、材质、结构与位置 ? appropriate use of equipment operations substances, (lubricants, coolants, refrigerants, etc.) contacting products/containers/etc. 适当的设备运行时接触产品/容器等物质的使用（例如，润滑剂、冷却剂、制冷剂等等） ? cleaning procedures and cleaning validation清洁规程与清洁验证 ? controls to prevent contamination, particularly with any pesticides or any other toxic materials, or other drug or non-drug chemicals 预防污染的控制措施、尤其是杀虫剂或其它有毒物质、或其它药物与非药物化学物质 ? qualification, calibration and maintenance of refrigerators and freezers 电冰箱和冷冻机的确认、校验和维护保养 ? equipment qualification, calibration and maintenance, including computer qualification/validation and security 设备确认、校准与维护保养，包括计算机确认/验证和安全 ? control system for