欧盟药品流通法规详述.ppt

1、,the compliance group,Stan ONeill CPAPE 2011 年会,欧盟药品药品流通法规,EU Regulations on Drug Distributions,Guidelines on Good Distribution Practice of Medicinal Products for Human UseArticle 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,Personnel 人员 Documentation 文件 Premises and Equipment 房屋与设备 Deliverie

2、s to Customers 向客户交付 Returns 退货 Self Inspections 自检,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

3、Operated by Wholesalers should 批发商的质量系统应,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,Appoint Management Representative - “Responsible Person”- ea

4、ch 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,Training 培训 Provide training for various GDP op

5、erations 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,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： - Rece

6、ipt 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,Documentation 文件,Procedures Contd 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 pr

7、oducts - 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,Documentation 文件,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/事件均可追踪 Readily available 方便查阅 Re

8、tained 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,Documentation 文件,Records Contd 记录(续) Transactions between 以下交易的记录： (i) Manufacturers and Wholesalers 制造企业与批发企业 (ii) Between Wholesalers 批发企业之间 ensu

9、re traceability of origin/destination products i.e. Batch numbers to identify suppliers and those supplied with medicinal products 能保证产品起点/终点的追踪性，如用批号来识别供应商及其发的药品,Documentation 文件,Suitable and adequate to ensure proper conservation/ distribution 适用并足以保证贮存/分销正确无误 Monitoring devices should be calibrat

10、ed 监控装置应当进行校准 Receiving 接收 Receiving bays protect deliveries 有保护收货的区域 Receiving area separate from storage areas 收货区域与储存区域分开 Deliveries examined on receipt 在收货时检查产品 Damage 有无损坏 corresponds to the order 与定单是否相符,Premises and Equipment库房设施与设备,Storage 储存 Medicinal products separate from other goods 药品与其

11、它产品分开 Conditions specified - protect from light, moisture, below 25 规定条件-避光,防潮,低于25 Temperature monitoring documented 温度监测有记录 Records reviewed regularly 定期审核记录 Temperature Mapping. Storage areas/cold rooms 温度分布、储存区/冷库,Premises and Equipment库房设施与设备,Ensure all locations within specific temperature ran

12、ge 保证所有区域都在规定的温度范围内 25oC 2 - 8oC,Premises and Equipment库房设施与设备,Storage Facility 储存设施 Clean 清洁 Free from litter, dust, pests 无废弃物、灰尘、虫害 Free from spillage or breakage 没有溢出或损坏 Microcontamination 微生物污染 Cross contamination 交叉污染 Stock Rotation 库存流转 “First in First out” Regular checks “先进先出”定期检查,Premises

13、and Equipment库房设施与设备,Out of Date or Damaged Stock 将过期或损坏库存 Quarantine 隔离/待检 Destroy 销毁,Premises and Equipment库房设施与设备,Authorised Wholesalers 批准的批发商 Persons authorised to supply Medicinal Products 经批准可从事药品流通的人员 IMB will look randomly at customer list 爱尔兰药品管理局将在客户清单中随机抽查 Supply Document 提供的文件应有： Date 日

14、期 Name and Pharmaceutical Form 名称与药品剂型 Quantity supplied 供应数量,Deliveries to Customers向客户发货,Supplier and addressee 供应商以及地址 Name and address 名称与地址 Product Shelf Life 产品有效期 Product dispatched must have a minimum defined shelf life remaining 所发送的产品必须具有所规定最短有效期,Deliveries to Customers向客户发货,Transportation

15、 运输 Ensure that 保证： Identification is not lost 不丢失标识 Cross Contamination is avoided 避免交叉污染 Products are secure 产品安全 Breakage & theft are avoided 避免损坏与偷窃 Protected from unacceptable environmental conditions 防止环境条件不符合要求 Temperature is controlled during transport 在运输中温度受控,Deliveries to Customers向客户发货,C

16、old Chain 冷链 Products requiring refrigeration must be delivered in 需要冷冻产品必须在下列条件下发运 Refrigerated transport 冷冻运输 Insulated boxes 绝热箱 Validate worst case situation during transport 验证在运输中最坏情况状态 Ensure product does not come in contact with ice packs 保证产品不接触冰袋 Responsible Person - ensure adequate delive

17、ry conditions maintained 负责人-保证保持足够的交付条件,Deliveries to Customers向客户发货,Controlled Drugs 受控药物 Maintain Security Chain 保持发货各环节的安全 Separate control drugs in deliveries to facilitate transfer 受控药品要采用单独发送方式，方便移交 Deliver direct to pharmacist at the hospital or retail outlet 直接交到医院或零售店的药剂师,Deliveries to Cus

18、tomers向客户发货,Non Defective Medicinal Products 无缺陷药品 Segregation from Saleable Stock until checked 与销售库存相隔离，直到经过检查 Products in good condition - original unwrapped containers 产品保持良好状态 - 容器为原始包装未经开封 Products stored under proper conditions 产品在正确条件下储存 Remaining shelf life acceptable 仍有可接受的有效期,Returns 退货,P

19、roducts examined and assessed by authorised, trained personnel 产品由经过批准及培训人员的检测与评估 Special storage conditions - time elapsed since issue 特别储存条件-自从发货起的持续时间 Maintain records of returned goods 保存退货记录 Return to stock operating FIFO System 退回仓库，按先进先出要求管理,Returns 退货,Product Disposal 产品处置 Returned, Rejected

20、 or Recalled Products 退回，拒绝或召回产品 Decision documented & recorded by Responsible Person 决定文件与负责人的记录 Disposal in a timely manner 以及时的方式处置,Returns 退货,Conduct and Record Self Inspections to monitor the implementation of and compliance with GDP Guidelines 对执行流通管理规范情况进行自检并做好记录： Self Inspection Procedure 自检

21、程序 Inspection Reports 检查报告 Follow up Actions 跟踪措施 Inspection Log 检查日志,Self Inspection 自检,Quality Management 质量管理 No Quality System available 没有质量系统 No System for Control of Documentation - Issue/Retrieval 无系统控制文件的发放/与收回 Master copies SOPS not approved by R. Person 基准SOP（原版）没有经过负责人批准 No Policy re.没有以

22、下相关的方针： Minimum acceptable product dating 最短可接受产品有效期 Return of refrigerated products 冷冻产品退货,GDP Deficiencies General 执行流通规范常中的见缺陷,Personnel 人员 Company training programme not available 公司没有培训计划 No training SOP for GDP operations 没有培训流通管理规范的SOP Personnel training not documented 人员培训没有记录,GDP Deficienci

23、es General执行流通规范常中的见缺陷,Documentation 文件 Relevant SOPs not available in areas of operation 在操作区域没有相关的SOP SOPs not available for 没有下列SOP： Receipt and checking of deliveries 对到货的接收与检查 Warehouse cleaning/pest control 仓库的清洁/虫害控制 Temperature monitoring 温度监测 Customer complaints 客户投诉,GDP Deficiencies Genera

24、l执行流通规范常中的见缺陷,Customer complaints not closed out in a timely manner 没有及时处理（了结）客户的投诉 No customer complaint log maintained 没有保留客户投诉记录 Service/calibration reports not reviewed 没有审核校准/ 维修报告 Pest control reports not reviewed 没有经过审核虫害控制报告 Calibration certs - acceptable error limit not specified 校准证明-没有具体规

25、定误差限度,GDP Deficiencies General执行流通规范常中的见缺陷,Premises and Equipment 库房与设备 Unauthorised products supplied 发了未批准的产品 Premises maintained in an untidy/dirty condition 库房处于肮乱状态 Products not stored on pallets 产品没有用托盘储存 Inadequate segregation receiving / picking/ dispatch areas 接收/检料/发放区域没有适当隔离 Out of date/s

26、hort dated stock in inventory 过期/短有效期产品没有库存清单,GDP Deficiencies General执行流通规范常中的见缺陷,Temperature Mapping 温度分布 Not performed 没有进行 Product stored in close proximity to unit heaters 产品近热源储存 Temperature probes not calibrated 温度传感器没有经过校准,GDP Deficiencies General执行流通规范常中的见缺陷,Premises and Equipment Contd 库房与

27、设备(续) Temperature excursions in cold room not investigated 冷库温度超出范围，没做调查 Data loggers not calibrated within operating range 没有对数据自动记录仪在其运行范围内对校准 MDA Drugs MDA药品 Inadequate control. Poor security 没有足够控制，安全性不良,GDP Deficiencies General执行流通规范常中的见缺陷,Discrepancies not adequately investigated 对差异情况没有适当调查 D

28、angerous storage practices 储存做法危险： Rat poison stored over Baby Food Products 将毒鼠药储存在婴儿食品上 Organophosphorus compds stored over open 将有机磷化合物存放在上面 containers packaging components 容器包装成分。,GDP Deficiencies General执行流通规范常中的见缺陷,Deliveries to Customers 向客户发货 Cold storage units for delivery refrigerated prod

29、ucts not validated 发货用冷藏产品的冷储存单元没有经过验证 Inadequate control re. ice packs 没有足够控制，如冰袋 Inadequate security of MDA drugs 对于MDA药品没有足够的安全性,GDP Deficiencies General执行流通规范常中的见缺陷,Returns 退货 No SOP Re. return of product to saleable stock 将退货产品到销售仓库无SOP Personnel not trained Re. checking returned goods 没有对人员进行退

30、回货物检查的培训,GDP Deficiencies General执行流通规范常中的见缺陷,Self Inspection 自检 No SOP defining Self Inspection 没有SOP来规定自检 Regular inspections not performed 没有进行定期检查 Reports not issued 自检无报告 Follow up actions not documented 跟踪措施无记录 Log of inspections not maintained 没有保存检查记录,GDP Deficiencies General执行流通规范常中的见缺陷,Cur

31、rent GDP Guideline 现行GDP指南 Guidelines on GDP of Medicinal Products for HumanUse (94/C 63/03) 人用药品流通管理规范(94/C 63/03) http:/ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htm since 1994 从1994年开始 out dated 已过期 limited scope, not detailed, no clear guidance 范围狭，不详细，缺乏明确的指导性 not reflecting curre

32、nt activities observed in wholesale distribution 不能反映现行药品流通的相关活动,Developments new guidelines制订-新的指南,Complex distribution networks where all players not wholesale distributors as defined in Directive 2001/83/EC 在复杂的药品流通网络中的各种角色，并非都是 2001/83/EC号法令中定义的批发商 This leads to inconsistencies in MS with respec

33、t to licensing and control of e.g. virtual wholesalers, outsourcing activities, brokers, transportation 这在药品销售中，导致虚拟的批发商、外部采购活动、中间商、运输企业发放许可证及管理等方面的矛盾,Why a new guideline?为什么要一个新指南?,New legislative requirements arising from proposal from Commission (identification of GDP requirements and obligations

34、 for brokers, verification of suppliers). These need to be incorporated into GDP Guidelines 新立法要求来自委员会的提议(鉴别药品流通的要求以及中间商，各供应企业的义务)，这需整合到GDP指南中 Lack of harmonisation different procedures/formats at Community level and international level 缺乏协调在欧盟层面与国际层面上有不同的程序/格式,Why a new guideline?为什么要一个新指南?,Compute

35、rised systems 计算机化的系统 Management of contract arrangements 委托管理 Transparency in supply chain 供应链透明度 Transportation 运输 Counterfeit controls 假药控制,Likely new components可能的新的内容,Subject all actors in distribution chain to conditions of wholesaling (except pharmacies, retailers) 取决于所有分销链的参与者至批发商条件(除药房，零售商外

36、) More stringent verification of suppliers by wholesalers 批发商对供货商将会有更严格的检查 GDP Community database (EudraGDP) 药品流通欧盟数据库 Strengthen GDP compliance inspections: 强化药品流通的达标检查: “Compilation of Community Procedures for GDP“ “欧盟将流通规程进行汇编”,Potential impacts 潜在影响,GDP Drafting Group Established 2008 (EMA) 欧盟药品管理局流通规范起草小组于2008年成立 Concept Paper on revision published February 2009 修订的概念文件已于2009年2月公布 Deadline for Comments May 2009 征求意见截止日期2009年5月 Guideline on GDP 药品流通指南 well advanced 相当先进,Work in progress 工作进展,harmonised with WHO Guideline 与WHO指南相协调/一致 draft fo