欧盟药品流通法规详述

1、the compliance groupStan ONeillCPAPE 2011 年会欧盟药品药品流通法规EU Regulations on Drug DistributionsGuidelines on GoodDistribution Practice of MedicinalProductsforHumanUseArticle10EUDir 92/25/EEC人用药品品流通质质量管理理指南欧盟第92/25/EEC号法令第第10款Personnel人员Documentation文件PremisesandEquipment房屋与设设备Deliveries to Customers向客户交交

2、付Returns退货Self Inspections自检Ensureproductsare authorised保证产品品经过批批准Storage conditionsare observed (alltimes)关注产品品储存条条件(任何时候候)Prevent contaminationfromotherproducts预防来自自其它产产品的污污染Ensureadequateturnoverofproducts保证足够够的产品品流转量量Deliver right products交付产品品正确无无误Quality SystemOperatedbyWholesalersshould批发商的的质

3、量系系统应RightAddress发货地址址正确SatisfactoryPeriod发货斯让让用户满满意Provide tracingsystem forfaultyproducts具备追踪踪系统，追踪有有问题的的产品EffectiveRecall Procedure有效的召召回程序序Quality SystemOperatedbyWholesalersshould批发商的的质量系系统Appoint ManagementRepresentative-“ResponsiblePerson”-eachdistributioncentre每个分销销中心须须指定-“负责人”-即管理代代表Appropr

4、iately qualified适当的资质Implementand maintain QualitySystem来实施与与保持质质量系统统KeyPersonnel关键人员员Appropriateability andexperience to guaranteeproductsareproperlyhandled有适当的的能力与与经验来来保证产产品正确确处理Personnel人员Training培训Provide training forvarious GDPoperations提供不同同GDP操作的培培训Trainingprogrammes培训计划划Maintaintrainingrecor

5、ds保存培训训记录Personnel人员Procedures程序Written proceduresshould describe thedifferentoperationswhichmayaffect应当有书书面规程程来描述述不同的的操作，它们可可能影响响：thequalityoftheproducts产品质量量thedistribution activity分销活动动Procedures for有以下规规程：-Receipt andcheckingofdeliveries发送产品品的接收/检查-Storage储存Cleaningandmaintenanceofpremises贮存厂房房的

6、清洁洁与维护护Documentation文件Procedures Contd程序(续)Recordingofstorageconditions记录储存存条件Securityonsite or in transit现场或运运送安全全Withdrawal fromsaleablestock从销售仓仓库撤回回Records of-orders记录-定单-returnedproducts-退货Recallplans召回计划划Procedures forvarious operationsshould be approved,signedand dated by theResponsiblePerson

7、各种规程程均应经过负负责人的的批准，签字与与签发日日期Documentation文件Records记录Made wheneachoperationistaking place每次操作作时均应应记录Activities andeventsare traceable活动/事件均可可追踪Readily available方便查阅阅Retainedfor5yearsatleast至少保留留5年Each purchase andsale每次采购购与销售售有：Date日期product/quantity产品/数量name andaddress of supplier/consignee发货企业业/收货人的

8、的名称与与地址Documentation文件Records Contd记录(续)Transactionsbetween以下交易易的记录录：(i)ManufacturersandWholesalers制造企业业与批发发企业(ii) BetweenWholesalers批发企业业之间ensuretraceability of origin/destinationproductsi.e. Batch numberstoidentifysuppliers andthosesuppliedwith medicinalproducts能保证产产品起点点/终点的追追踪性，如用批批号来识识别供应应商及其其发的

9、药药品Documentation文件Suitableandadequatetoensure properconservation/ distribution适用并足足以保证证贮存/分销正确确无误Monitoring devicesshould be calibrated监控装置置应当进进行校准准Receiving接收Receivingbaysprotect deliveries有保护收收货的区区域Receivingareaseparatefrom storageareas收货区域域与储存存区域分分开Deliveries examined on receipt在收货时时检查产产品Damage有无

10、损坏坏correspondstotheorder与定单是是否相符符PremisesandEquipment库房设施施与设备Storage储存Medicinalproducts separate fromothergoods药品与其其它产品品分开Conditions specified- protectfromlight,moisture, below 25规定条件件-避光,防潮,低于25Temperaturemonitoring documented温度监测测有记录录Records reviewed regularly定期审核核记录TemperatureMapping.Storageareas

11、/cold rooms温度分布布、储存存区/冷库PremisesandEquipment库房设施施与设备Ensureall locationswithinspecifictemperaturerange保证所有有区域都都在规定定的温度度范围内内 25oC2 -8oCPremisesandEquipment库房设施施与设备Storage Facility储存设施施Clean清洁Free fromlitter,dust,pests无废弃物物、灰尘尘、虫害害Free fromspillageorbreakage没有溢出出或损坏坏Microcontamination微生物污污染Crosscontami

12、nation交叉污染染StockRotation库存流转“FirstinFirstout”Regular checks“先进先先出”定定期检查查PremisesandEquipment库房设施施与设备OutofDateorDamaged Stock将过期或损损坏库存存Quarantine隔离/待检Destroy销毁PremisesandEquipment库房设施施与设备Authorised Wholesalers批准的批批发商Persons authorisedtosupply MedicinalProducts经批准可可从事药药品流通通的人员员IMBwilllook randomly at

13、customer list爱尔兰药药品管理理局将在在客户清清单中随随机抽查查SupplyDocument提供的文文件应有有：Date日期Name andPharmaceuticalForm名称与药药品剂型型Quantitysupplied供应数量量Deliveries to Customers向客户发发货Supplierandaddressee供应商以以及地址址Name andaddress名称与地地址Product Shelf Life产品有效效期Product dispatchedmusthave aminimumdefined shelf liferemaining所发送的的产品必必须具

14、有有所规定定最短有有效期Deliveries to Customers向客户发发货Transportation运输Ensurethat保证：Identificationisnotlost不丢失标标识CrossContamination is avoided避免交叉叉污染Productsaresecure产品安全全Breakage& theft areavoided避免损坏坏与偷窃窃Protectedfromunacceptableenvironmentalconditions防止环境境条件不不符合要要求Temperatureiscontrolled duringtransport在运输中中温度

15、受受控Deliveries to Customers向客户发发货Cold Chain冷链Productsrequiringrefrigerationmust be deliveredin需要冷冻冻产品必必须在下下列条件件下发运运Refrigeratedtransport冷冻运输输Insulatedboxes绝热箱Validateworstcase situationduringtransport验证在运运输中最最坏情况况状态Ensureproductdoes notcome in contactwithicepacks保证产品品不接触触冰袋ResponsiblePerson-ensureade

16、quatedeliveryconditionsmaintained负责人-保证保持持足够的的交付条条件Deliveries to Customers向客户发发货Controlled Drugs受控药物物MaintainSecurityChain保持发货货各环节节的安全全Separatecontrol drugs in deliveriestofacilitatetransfer受控药品品要采用用单独发发送方式式，方便便移交Deliver directtopharmacist at thehospitalorretailoutlet直接交到到医院或或零售店店的药剂剂师Deliveries to

17、Customers向客户发发货NonDefective MedicinalProducts无缺陷药药品Segregationfrom Saleable Stock until checked与销售库库存相隔隔离，直直到经过过检查Productsingood condition- original unwrappedcontainers产品保持持良好状状态-容器为原原始包装装未经开开封Productsstoredunderproper conditions产品在正正确条件件下储存存Remainingshelflifeacceptable仍有可接接受的有有效期Returns退货Productsex

18、aminedandassessedbyauthorised,trainedpersonnel产品由经经过批准准及培训训人员的的检测与与评估Special storageconditions- timeelapsedsinceissue特别储存存条件-自从发货货起的持持续时间间Maintainrecords of returned goods保存退货货记录Returntostockoperating FIFOSystem退回仓库库，按先先进先出出要求管管理Returns退货Product Disposal产品处置置Returned,RejectedorRecalledProducts退回，拒拒绝

19、或召召回产品品Decisiondocumented &recordedbyResponsiblePerson决定文件件与负责责人的记记录Disposalina timelymanner以及时的的方式处处置Returns退货Conduct andRecordSelfInspectionstomonitor theimplementationofand compliancewithGDPGuidelines对执行流流通管理理规范情情况进行行自检并并做好记记录：Self InspectionProcedure自检程序序Inspection Reports检查报告告FollowupActions跟踪措

20、施Inspection Log检查日志志Self Inspection自检Quality Management质量管理理NoQuality Systemavailable没有质量量系统NoSystemfor ControlofDocumentation- Issue/Retrieval无系统控控制文件件的发放放/与收回Mastercopies SOPSnot approved by R. Person基准SOP（原版）没有经经过负责责人批准准NoPolicyre.没有以下下相关的的方针：Minimum acceptableproductdating最短可接接受产品品有效期期Returnofre

21、frigerated products冷冻产品品退货GDPDeficiencies General执行流通通规范常常中的见见缺陷Personnel人员Company training programmenotavailable公司没有有培训计计划NotrainingSOPfor GDPoperations没有培训训流通管管理规范范的SOPPersonneltrainingnot documented人员培训训没有记记录GDPDeficiencies General执行流通通规范常常中的见见缺陷Documentation文件RelevantSOPs notavailableinareasofop

22、eration在操作区区域没有有相关的的SOPSOPs notavailablefor没有下列列SOP：Receipt andcheckingofdeliveries对到货的的接收与与检查Warehousecleaning/pestcontrol仓库的清清洁/虫害控制制Temperaturemonitoring温度监测测Customercomplaints客户投诉诉GDPDeficiencies General执行流通通规范常常中的见见缺陷Customercomplaints notclosedout in atimely manner没有及时时处理（了结）客户的的投诉Nocustomerco

23、mplaintlog maintained没有保留留客户投投诉记录录Service/calibration reportsnot reviewed没有审核核校准/维修报告告Pest controlreportsnotreviewed没有经过过审核虫虫害控制制报告Calibrationcerts- acceptableerrorlimitnot specified校准证明明-没有具体体规定误误差限度度GDPDeficiencies General执行流通通规范常常中的见见缺陷PremisesandEquipment库房与设备Unauthorisedproductssupplied发了未批批准的产

24、产品Premisesmaintained in an untidy/dirtycondition库房处于于肮乱状状态Productsnotstored on pallets产品没有有用托盘盘储存Inadequate segregation receiving/ picking/ dispatch areas接收/检料/发放区域域没有适适当隔离离Outofdate/shortdatedstockininventory过期/短有效期期产品没没有库存存清单GDPDeficiencies General执行流通通规范常常中的见见缺陷TemperatureMapping温度分布布Notperformed

25、没有进行行Product storedincloseproximitytounitheaters产品近热热源储存存Temperatureprobesnot calibrated温度传感感器没有有经过校校准GDPDeficiencies General执行流通通规范常常中的见见缺陷PremisesandEquipment Contd库房与设备(续)Temperatureexcursions in coldroomnotinvestigated冷库温度度超出范范围，没没做调查查Data loggersnot calibratedwithin operatingrange没有对数数据自动动记录仪仪在

26、其运运行范围围内对校校准MDADrugsMDA药品Inadequate control.Poor security没有足够够控制，安全性性不良GDPDeficiencies General执行流通通规范常常中的见见缺陷Discrepancies notadequately investigated对差异情情况没有有适当调调查Dangerousstoragepractices储存做法法危险：Ratpoison storedover BabyFoodProducts将毒鼠药药储存在在婴儿食食品上Organophosphorus compdsstoredoveropen将有机磷磷化合物物存放在在上面

27、containers packagingcomponents容器包装装成分。GDPDeficiencies General执行流通通规范常常中的见见缺陷Deliveries to Customers向客户发发货Cold storageunitsfor delivery refrigeratedproductsnotvalidated发货用冷冷藏产品品的冷储储存单元元没有经经过验证证Inadequate controlre. icepacks没有足够够控制，如冰袋袋Inadequate security of MDAdrugs对于MDA药品没有有足够的的安全性性 GDPDeficiencies

28、General执行流通通规范常常中的见见缺陷Returns退货NoSOPRe. returnofproduct to saleable stock将退货产产品到销销售仓库库无SOPPersonnelnot trainedRe. checking returned goods没有对人人员进行行退回货货物检查查的培训训GDPDeficiencies General执行流通通规范常常中的见见缺陷Self Inspection自检NoSOPdefiningSelfInspection没有SOP来规定自自检Regular inspections notperformed没有进行行定期检检查Reports

29、 notissued自检无报报告Followupactionsnotdocumented跟踪措施无记记录Logofinspectionsnot maintained没有保存存检查记记录GDPDeficiencies General执行流通通规范常常中的见见缺陷Current GDPGuideline现行GDP指南Guidelines on GDPofMedicinalProductsfor HumanUse (94/C 63/03)人用药品品流通管管理规范范(94/C63/03)http:/ec.europa.eu/enterprise/pharmaceuticals/eudralex/hom

30、ev4.htmsince1994从1994年开始outdated已过期limited scope,notdetailed, no clear guidance范围狭，不详细细，缺乏乏明确的的指导性性notreflectingcurrent activitiesobservedinwholesale distribution不能反映映现行药药品流通通的相关关活动Developmentsnewguidelines制订-新的指南南Complex distributionnetworkswhereallplayersnotwholesale distributorsasdefined in Direc

31、tive2001/83/EC在复杂的的药品流流通网络络中的各各种角色色，并非非都是2001/83/EC号法令中中定义的的批发商商This leads to inconsistenciesinMSwith respecttolicensing andcontrol of e.g.virtualwholesalers,outsourcingactivities,brokers,transportation这在药品品销售中中，导致致虚拟的的批发商商、外部部采购活活动、中中间商、运输企企业发放放许可证证及管理理等方面面的矛盾盾Whyanewguideline?为什么要要一个新新指南?Newlegisl

32、ativerequirements arisingfromproposalfrom Commission(identification of GDPrequirementsand obligations forbrokers,verificationofsuppliers).TheseneedtobeincorporatedintoGDPGuidelines新立法要要求来自自委员会会的提议议(鉴别药品品流通的的要求以以及中间间商，各各供应企企业的义义务)，这需整整合到GDP指南中Lack of harmonisationdifferentprocedures/formatsatCommunit

33、y level andinternational level缺乏协调调在欧盟层层面与国国际层面面上有不不同的程程序/格式Whyanewguideline?为什么要要一个新新指南?Computerisedsystems计算机化化的系统统Management of contract arrangements委托管理理Transparencyinsupply chain供应链透透明度Transportation运输Counterfeitcontrols假药控制制Likelynew components可能的新新的内容容Subject allactorsindistribution chain to

34、conditionsofwholesaling(exceptpharmacies,retailers)取决于所所有分销销链的参参与者至至批发商商条件(除药房，零售商商外)More stringentverificationofsuppliers by wholesalers批发商对对供货商商将会有有更严格格的检查查GDPCommunity database (EudraGDP)药品流通通欧盟数数据库Strengthen GDPcompliance inspections:强化药品品流通的的达标检检查:“CompilationofCommunity Proceduresfor GDP“欧盟将将流

35、通规规程进行行汇编”Potentialimpacts潜在影响响GDPDraftingGroupEstablished2008(EMA)欧盟药品品管理局局流通规规范起草草小组于于2008年成立Concept Paper on revision publishedFebruary2009修订的概概念文件件已于2009年2月公布DeadlineforCommentsMay2009征求意见见截止日日期2009年5月GuidelineonGDP药品流通通指南well advanced相当先进进Work in progress工作进展展harmonised withWHO Guideline与WHO指南相协协调/一致draftforpublic co