欧盟药品流通法规详述课件

Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,*,Click to edit Master title style,Click to edit Master text styles,Second Level,Third Level,Fourth Level,Fifth Level,the,compliance,group,Stan ONeill,CPAPE 2011,年会,欧盟药品药品流通法规,EU,R,egulations on,D,rug,D,istributions,the Stan ONeill欧盟药品药品流通法规EU R,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,Deliveries to Customers,向客户交付,Returns,退货,Self Inspections,自检,Guidelines on Good Distributio,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,Ensure products are authorised,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,Right AddressQuality System Op,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,Appoint Management Representat,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,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 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,Documentation,文件,Procedures 程序Documentatio,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 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)Doc,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,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Documentatio,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,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)Doc,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 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,Premises and Equipment,库房设施,与设备,Suitable and adequate to ensur,Storage,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,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,Storage 储存Premises and Equi,Ensure all locations within specific temperature range,保证所有区域都在规定的温度范围内,25,o,C,2-8,o,C,Premises and Equipment,库房设施,与设备,Ensure all locations within sp,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 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,Premises 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,Authorised 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 lo