欧盟药品GDP及药品冷链技术.pptVIP

欧盟药品GDP及药品冷链技术;Guidelines on Good Distribution Practice of Medicinal Products for Human Use[Article 10 EU Dir 92/25/EEC]人用药品流通质量管理指南 [欧盟第92/25/EEC号法令第10款];Ensure products are authorised 保证产品经过批准 Storage conditions are observed (all times) 关注产品储存条件(任何时候) Prevent contamination from other products 预防来自其它产品的污染 Ensure adequate turnover of products 保证足够的产品流转量 Deliver right products 交付产品正确无误;Right Address 发货地址正确 Satisfactory Period 发货斯让用户满意 Provide tracing system for faulty products 具备追踪系统，追踪有问题的产品 Effective Recall Procedure 有效的召回程序 ;Appoint Management Representative - “Responsible Person”- each