欧盟药品gdp与药品冷链技术(1).ppt

欧盟药品GDP及药品冷链技术(1);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 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;Training 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 ;Procedures 程序 Written procedures should describe the different operations which may affect 应当有书面规程来描述不同的操作，它们可能影响： the quality of the products 产品质量 the distribution activity 分销活动 Procedures for 有以下规程： - Receipt and checking of deliveries 发送产品的接收/检查 - Storage 储存 Cleaning and maintenance of premises 贮存厂房的清洁与维护;Procedures Cont’d 程序(续) Recording of storage conditions 记录储存条件 Security on site or in transit 现场或运送安全 Withdrawal from saleable stock 从销售仓库撤回 Records of - orders 记录 -定单 - returned products - 退货 Recall plans 召回计划 Procedures for various operations should be approved, signed and dated by the Responsible Person 各种规程均应经过负责人的批准，签字与签发日期;Records 记录 Made when each operation is taking place 每次操作时均应记录 Activities and events are traceable 活动/事件均??追踪 Readily available 方便查阅 Retained for 5 years at least 至少保留5年 Each purchase and sale 每次采购与销售有： Date 日期 product/quantity 产品/数量 name and address of supplier/consignee 发货企业/收货人的名称与地址;Records Co