欧盟药品GDP及药品冷链技术.ppt

PPT PPT 文档演模板 文档演模板 Office Office PPT PPT欧盟药品GDP 及药品冷链技术2023/6/12 欧盟药品GDP 及药品冷链技术PPT PPT 文档演模板 文档演模板 Office Office PPT PPTGuidelines on Good Distribution Practice of Medicinal Guidelines on Good Distribution Practice of Medicinal Products for Human UseArticle 10 EU Dir 92/25/EEC Products for Human UseArticle 10 EU Dir 92/25/EEC 人用药 人用药品流通质量管理指南 品流通质量管理指南 欧盟第 欧盟第92/25/EEC 92/25/EEC 号法令第 号法令第10 10 款 款 Personnel 人员 Documentation 文件 Premises and Equipment 房屋与设备 Deliveries to Customers 向客户交付 Returns 退货 Self Inspections 自检欧盟药品GDP 及药品冷链技术PPT PPT 文档演模板 文档演模板 Office Office PPT PPT 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Quality System Operated by Wholesalers should 批发商的质量系统应欧盟药品GDP 及药品冷链技术PPT PPT 文档演模板 文档演模板 Office Office PPT PPT 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Quality System Operated by Wholesalers should 批发商的质量系统欧盟药品GDP 及药品冷链技术PPT PPT 文档演模板 文档演模板 Office Office PPT PPT Appoint Management Representative-“Responsible Person”-each distribution centre 每个分销中心须指定-“负责人”-即管理代表 Appropriately qualified 适当的资质 Implement and maintain Quality System来实施与保持质量系统 Key Personnel 关键人员Appropriate ability and experience to guarantee products are properly handled有适当的能力与经验来保证产品正确处理Personnel 人员欧盟药品GDP 及药品冷链技术PPT PPT 文档演模板 文档演模板 Office Office PPT PPTTraining 培训Provide training for various GDP operations提供不同GDP 操作的培训Training programmes培训计划Maintain training records保存培训记录Personnel 人员欧盟药品GDP 及药品冷链技术