非最终灭菌无菌制剂（冻干及粉针等）生产质量技术指导原则.docVIP

培养基模拟灌装试验 视频 无菌操作培训 Management Reviews 管理体系 Annual Product Review 年度产品质量回顾 Validation and Qualification Strategy – System验证实施体系 Deviations Failure Investigations偏差及失败调查 Complaints AE Review 投拆及不良反应回顾 Nonconformance CAPA 不符合事件及纠偏预防 Change Control变更控制 Training Qualification – Competency Matrix培训与资质 Stability稳定性考察 Cleaning Sanitation 清洁与消毒 Rework procedure返工程序 Retained Samples留样 Facilities (HVAC, Environment, Water) 公用设施 Calibration Maintenance procedures校验与预防维修 Rodent Pest Control虫鼠控制 Line Clearance procedures清场程序 Handling of Nonconforming product 不合格品处理 Products identification Con