GOOD DISTRIBUTION PRACTICES (GDP) FOR PHARMACEUTIC

应WorkingdocumentQAS/04.068/Rev.2RESTRICTEDWORLDHEALTHORGANIZATIONORGANISATIONMONDIALEDELASANTEGOODDISTRIBUTIONPRACTICES(GDP)FORPHARMACEUTICALPRODUCTS药制品良好的经销规则Thisdocumenthasfollowedthestepsgiveninthescheduleonpage2herein.Ithasbeenverywidelydistributedandnumerouscommentshavebeenincorporated.此文件遵循第二页给出的步骤。此文件已被广泛发布且融合了大量的评论Pleaseaddressanycommentsand/orcorrectionsyoumayhaveonthereontoDrS.Kopp,QualityAssuranceandSafety:Medicines,MedicinesPolicyandStandards,WorldHealthOrganization,1211Geneva27,Switzerland,fax:[phone]ore-mail:[e-mail],[e-mail],by20October2005.请把您的评论或者修正意见发给DrS.Kopp，地址为QualityAssuranceandSafety:Medicines,MedicinesPolicyandStandards,WorldHealthOrganization,1211Geneva27,Switzerland,传真为([phone]，邮箱为：。同时还要在2005年10月20日前把上述邮件发到[e-mail],©WorldHealthOrganization2005Allrightsreserved.Thisdraftisintendedforarestrictedaudienceonly,i.e.theindividualsandorganizationshavingreceivedthisdraft.Thedraftmaynotbereviewed,abstracted,quoted,reproduced,transmitted,distributed,translatedoradapted,inpartorinwhole,inanyformorbyanymeansoutsidetheseindividualsandorganizations(includingtheorganizations’concernedstaffandmemberorganizations)withoutthepermissionofWHO.Thedraftshouldnotbedisplayedonanywebsite.Pleasesendanyrequestforpermissionto:DrSabineKopp,QualityAssurance&Safety:Medicines(QSM),DepartmentofMedicinesPolicyandStandards(PSM),WorldHealthOrganization,CH-1211Geneva27,Switzerland.Fax:[phone];e-mails:[e-mail];[e-mail]edandthepresentationofthematerialinthisdraftdonotimplytheexpressionofanyopinionwhatsoeveronthepartoftheWorldHealthOrganizationconcerningthelegalstatusofanycountry,territory,cityorareaorofitsauthorities,orconcerningthedelimitationofitsfrontiersorboundaries.Dottedlinesonmapsrepresentapproximateborderlinesforwhichtheremaynotyetbefullagreement.Thementionofspecificcompaniesorofcertainmanufacturers’productsdoesnotimplythattheyareendorsedorrecommendedbytheWorldHealthOrganizationinpreferencetoothersofasimilarnaturethatarenotmentioned.Errorsandomissionsexcepted,thenamesofproprietaryproductsaredistinguishedbyinitialcapitalletters.TheWorldHealthOrganizationdoesnotwarrantthattheinformationcontainedinthisdraftiscompleteandcorrectandshallnotbeliableforanydamagesincurredasaresultofitsuse.WorkingdocumentQAS/04.068/Rev.2page2SCHEDULEFORTHEADOPTIONPROCESSOFDOCUMENTQAS/04.068/REV.2:GOODDISTRIBUTIONPRACTICES(GDP)FORPHARMACEUTICALPRODUCTS文件的采用过程计划药制品的良好经销规则Deadline截止日Firstdraftpreparedandmailedforcomments撰写首稿后将其邮寄以获取评论January2004Deadlineforreceiptofcomments接受评论的截止日31March2004Collationofcomments收集评论May2004Revisionofdraftdocument修订草拟文件October2004PresentationtoThirty-ninthWHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations向39位WHO专家委员介绍制药准备的规格问题25-29October2004Mailingoffirstrevisionforcomment邮寄首个修订本以获取评论March2005Collationofcomments收集评论April2005Discussioninconsultation共同谈论协商May2005Revisionofdraftdocument修订草拟文件June-July2005Mailingofsecondrevisionforcomment邮寄第二次修订本以获取评论September2005Collationofcomments收集评论September-October2005PresentationtoFortiethWHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations对39位WHO专家委员介绍制药准备的规格问题对39位WHO专家委员介绍药业准备的规格问题对39位WHO专家委员介绍药业准备的规格问题24-28October2005WorkingdocumentQAS/04.068/Rev.2page3GOODDISTRIBUTIONPRACTICES(GDP)FORPHARMACEUTICALPRODUCTSCONTENTS目录page1.Introduction介绍……………………………………………………32.Scopeofthedocument文件范围……………………………...…53.Glossary术语……………………………………………………….54.Organizationandmanagement组织和管理…………………..105.Personnel人员…………………………………………………...116.Qualitymanagement质量管理……………………………………….127.Premises,warehousingandstorage经营场地，储仓…..138.Vehiclesandequipment车辆和设备………………………………169.Containersandcontainerlabelling容器和容器标签…………………1710.Dispatch分派……………………………………………………1811.Transportationandproductsintransit……………………………..2012.Documentation……………………………………………………..2113.Repackagingandrelabelling……………………………………….2314.Complaints…………………………………………………………2315.Recalls……………………………………………………………...2316.Rejectedandreturnedproducts…………………………………….2417.Counterfeitpharmaceuticalproducts……………………………….2518.Importation………………………………………………………….2519.Contractactivities…………………………………………………..2620.Self-inspection……………………………………………………...2621.Bibliography………………………………………………………..261.INTRODUCTION介绍Distributionformsanimportantactivityoftheintegratedsupplychainmanagementofpharmaceuticalproducts.Variouspersonsandentitiesareoftenresponsibleforthehandling,WorkingdocumentQAS/04.068/Rev.2经销是形成药制品综合供应链管理的重要举措。各方面的人员和实体要对操作和工作文件负责page4storageanddistributionofsuchproducts.Insomecases,however,apersonorentityinvolvedinthedistributionofpharmaceuticalproductsisonlyinvolvedinandisresponsibleforcertainelementsofthedistributionprocess.Thisdocumentsetsoutappropriatestepstoassistinmeetingtheresponsibilitiesinvolvedinthedifferentaspectsofthedistributionprocess.Theguidelinesareintendedtoapplytoallstepsintheentiredistribution/supplychain.Therelevantsectionsshouldbeconsideredbyvariousroleplayersasapplicabletotheirparticularroleinthedistributionprocess.Thedocumentdoesnotcoverspecificallyfinishedp