欧盟药品GDP及药品冷链技术课件1

1、欧盟药品GDP及药品冷链技术课件1欧盟药品GDP及药品冷链技术课件1Guidelines 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Deliveries to Customers 向客户交付Returns 退货Self Inspections 自检Guidelines on Goo

2、d DistributioEnsure 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Ensure p

3、roducts are authorisedRight 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Right AddressQuality System OpAppoint Management Representative - “Responsible Person”-

4、 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Appoint Management RepresentatTraining 培训Provide tra

5、ining 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Training 培训Personnel 人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 activi

6、ty 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Documentation 文件Procedures 程序DocumentatioProcedures 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 st

7、ock 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Documentation 文件Procedures Contd 程序(续)DocRecords 记录Made when each operation is taking place每次操作时均应记录Act

8、ivities and events are traceable 活动/事件均可追踪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Documentation 文件Records 记录DocumentatioRecords Contd 记录(续) Transactions between 以下交易的记录：

9、 (i) Manufacturers and Wholesalers制造企业与批发企业 (ii) Between Wholesalers 批发企业之间ensure 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Records Contd 记录(续)DocSuitable and adequate

10、to ensure proper conservation/ distribution 适用并足以保证贮存/分销正确无误Monitoring devices should be calibrated 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P

11、remises and Equipment库房设施与设备Suitable and adequate to ensurStorage 储存Medicinal products separate from other goods药品与其它产品分开Conditions specified - protect from light, moisture, below 25 规定条件-避光,防潮,低于25Temperature monitoring documented温度监测有记录Records reviewed regularly 定期审核记录Temperature Mapping. Storage

12、areas/cold rooms 温度分布、储存区/冷库Premises and Equipment库房设施与设备Storage 储存Premises and EquiEnsure all locations within specific temperature range保证所有区域都在规定的温度范围内 25oC 2 - 8oCPremises and Equipment库房设施与设备Ensure all locations within spStorage Facility 储存设施Clean 清洁Free from litter, dust, pests 无废弃物、灰尘、虫害Free

13、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 and Equipment库房设施与设备Storage Facility 储存设施Premis 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P

14、remises and Equipment库房设施与设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Authorise

15、d Wholesalers 批准的批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Supplier and addressee 供应Transportation 运输Ensure that 保证：Identification is not lost 不丢失标识Cros

16、s 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Transportation 运输DelivCold Chain 冷链Products requiring refrigerati

17、on 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 delivery conditions maintained 负责人-保证保持足够的交付条件Deliveri

18、es to Customers向客户发货Cold Chain 冷链DeliverControlled 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 Customers向客户发货Controlled Drugs 受控药物DNon

19、 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Non Defective Medicinal Pr

20、oducProducts 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Products examined and assessedProduct Dis

21、posal 产品处置Returned, Rejected 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Product Disposal 产品处置Conduct and Record Self Inspections to monitor the implementation of and compliance with GDP Guidelines对执行流通管理规

22、范情况进行自检并做好记录：Self Inspection Procedure 自检程序Inspection Reports 检查报告Follow up Actions 跟踪措施Inspection Log 检查日志Self Inspection 自检Conduct and Record Self InspecQuality 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 SOP

23、S 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Quality Management 质量管Personnel 人员 Company training programme not available公司没有培训计划 No training SOP for GDP opera

24、tions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 Deficiencies General执行流通规范常中的见缺陷Personnel 人员GDP DeficiDocumentation 文件Relevant SOPs not available in areas of operation 在操作区域没有相关的SOPSOPs 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 cont

25、rol仓库的清洁/虫害控制Temperature monitoring 温度监测Customer complaints 客户投诉GDP Deficiencies General执行流通规范常中的见缺陷Documentation 文件GDP DefCustomer 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 co

26、ntrol 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-没有具体规定误差限度GDP Deficiencies General执行流通规范常中的见缺陷Customer complaints not closedPremises 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

27、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/short 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Premises and Equipment Temperature Mapping 温度分布Not performed没有进行Product stored in close prox

28、imity 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Temperature Mapping 温度分布GDPremises and Equipment Contd 库房与设备(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

29、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Premises and Equipment Contd Discrepancies not adequately investigated对差异情况没有适当调查 Dangerous 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

30、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GDP Deficiencies General执行流Deliveries to Customers 向客户发货Cold storage units for delivery refrigerated products 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 se

31、curity 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Deliveries to Customers 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没有对人员进行退回货物检查的培训GDP Deficiencies General执行流通规范常中的见缺陷GDP Deficiencies General执行流Self

32、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Self Inspection 自检GDP Current GDP Guideline 现行GDP指南Guidelines on

33、 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.htmsince 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 current activities observed in wholesale distributi

34、on 不能反映现行药品流通的相关活动Developments new guidelines制订-新的指南Current GDP Guideline 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 respect to licensing and control o

35、f 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?Complex distribution networks New legislative requirements arising from proposal from Commission (identification of GDP requirements and obligations

36、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?New legislati

37、ve requirements aComputerised 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Computerised systems 计算机化的系Subject all actors in distribution chain to conditions of wholesaling (except pharma

38、cies, 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)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Subject all a

39、ctors in distribuGDP 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GDP Drafting Group Establishedharmonised with WHO Guideline与WHO指南相协调/一致draft for publi