GOOD DISTRIBUTION PRACTICES GDP FOR PHARMACEUTICAL PRODUCTS.docx

GOOD DISTRIBUTION PRACTICES GDP FOR PHARMACEUTICAL PRODUCTS.docx

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GOODDISTRIBUTIONPRACTICESGDPFORPHARMACEUTICALPRODUCTS

应WorkingdocumentQAS/04.068/Rev.2

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WORLDHEALTHORGANIZATIONORGANISATIONMONDIALEDELASANTE

GOODDISTRIBUTIONPRACTICES（GDP）FORPHARMACEUTICALPRODUCTS

药制品良好的经销规则

Thisdocumenthasfollowedthestepsgiveninthescheduleonpage2herein.Ithasbeenverywidelydistributedandnumerouscommentshavebeenincorporated.

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Pleaseaddressanycommentsand/orcorrectionsyoumayhaveonthereonto

DrS.Kopp,QualityAssuranceandSafety:

Medicines,MedicinesPolicyandStandards,WorldHealthOrganization,1211Geneva27,Switzerland,fax:

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TheWorldHealthOrganizationdoesnotwarrantthattheinformationcontainedinthisdraftiscompleteandcorrectandshallnotbeliableforanydamagesincurredasaresultofitsuse.

WorkingdocumentQAS/04.068/Rev.2page2

SCHEDULEFORTHEADOPTIONPROCESSOFDOCUMENTQAS/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

January2004

Deadlineforreceiptofcomments

接受评论的截止日

31March2004

Collationofcomments

收集评论

May2004

Revisionofdraftdocument

修订草拟文件

October2004

PresentationtoThirty-ninthWHOExpertCommitteeon

SpecificationsforPharmaceuticalPreparations

向39位WHO专家委员介绍制药准备的规格问题

25-29October2004

Mailingoffirstrevisionforcomment

邮寄首个修订本以获取评论

March2005

Collationofcomments

收集评论

April2005

Discussioninconsultation

共同谈论协商

May2005

Revisionofdraftdocument

修订草拟文件

June-July2005

Mailingofsecondrevisionforcomment

邮寄第二次修订本以获取评论

September2005

Collationofcomments

收集评论

September-October2005

PresentationtoFortiethWHOExpertCommitteeon

SpecificationsforPharmaceuticalPreparations

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

24-28October2005

WorkingdocumentQAS/04.068/Rev.2page3

GOODDISTRIBUTIONPRACTICES（GDP）FORPHARMACEUTICALPRODUCTS

CONTENTS目录

page

1.

Introduction介绍……………………………………………………

3

2.

Scopeofthedocument文件范围……………………………...…

5

3.

Glossary术语……………………………………………………….

5

4.

Organizationandmanagement组织和管理…………………..

10

5.

Personnel人员…………………………………………………...

11

6.

Qualitymanagement质量管理……………………………………….

12

7.

Premises,warehousingandstorage经营场地，储仓…..

13

8.

Vehiclesandequipment车辆和设备………………………………

16

9.

Containersandcontainerlabelling容器和容器标签…………………

17

10.

Dispatch分派……………………………………………………

18

11.

Transportationandproductsintransit……………………………..

20

12.

Documentation……………………………………………………..

21

13.

Repackagingandrelabelling……………………………………….

23

14.

Complaints…………………………………………………………

23

15.

Recalls……………………………………………………………...

23

16.

Rejectedandreturnedproducts…………………………………….

24

17.

Counterfeitpharmaceuticalproducts……………………………….

25

18.

Importation………………………………………………………….

25

19.

Contractactivities…………………………………………………..

26

20.

Self-inspection……………………………………………………...

26

21.

Bibliography………………………………………………………..

26

1.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

page4

storageanddistributionofsuchproducts.Insomecases,however,apersonorentityinvolvedinthedistributionofpharmaceuticalproductsisonlyinvolvedinandisresponsibleforcertainelementsofthedistributionprocess.Thisdocumentsetsoutappropriatestepstoassistinmeetingtheresponsibilitiesinvolvedinthedifferentaspectsofthedistributionprocess.Theguidelinesareintendedtoapplytoallstepsintheentiredistribution/supplychain.Therelevantsectionsshouldbeconsideredbyvariousroleplayersasapplicabletotheirparticularroleinthedistributionprocess.Thedocumentdoesnotcoverspecificallyfinishedproductsinbulk,distributionoflabelsandpackagingmaterials,asthisisconsideredtobecoveredbyotherguidelines,e.g.GMP.

产品的存储和经销。

参与药制品经销的单个人或者实体有时只是参与且负责某一部分经销流程。

此文件制定合适的步骤以帮助参与经销流程不同方面的人员能达到职责要求。

指导方针旨在运用于整体经销/供应链的所有环节。

不同的参与者应考虑相关部分以符合其在经销流程中的特定角色。

此文件没有明确地涉及大批量成品，标签和包装材料经销问题，而这些方面将涵盖在其他指导方针里如GMP

Practiceofrepacking,e.g.inpharmaciesandothersettings,needstobecarriedoutinaccordancewithgooddispensingpractices.

需根据良好的配药规则执行重新包装规则如发生在药房和其他情景下的重新包装

Thestorage,tradeanddistributionofpharmaceuticalproductsareactivitiesthatarecarriedoutbyvariouscompanies,institutionsandindividuals.Thenatureoftherisksinvolvedmaygenerally,however,bethesameasthoseinthemanufacturingenvironment,e.g.mix-ups,contaminationandcross-contamination.Therearethusaspectsindistributiontowhichtheprinciplesofgoodmanufacturingpractice（GMP）shouldbeapplied.Theseinclude,butarenotlimitedto,storage,distribution,transportation,packaging,labelling,documentationandrecord-keepingpractices.

由不同的公司，机构和个人执行药制品的存储，交易和经销活动。

总的来说，所涉及的风险种类与制造业面临的风险一样，如混乱，污染和交叉污染。

因此在经销方面也应运用良好的制造规则GMP。

此规则包括但不限于存储，经销，交通，包装，贴标，撰写文件和记录保存等这些方面

Thequalityofpharmaceuticalproductscanbeaffectedbyalackofadequatecontrolovernumerousactivitieswhichoccurduringthedistributionprocess.Furthermorethedistributionprocesshasgenerallynotbeenwell-emphasizedwithregardtotheneedforestablishment,development,maintenanceandcontrolovertheactivitiesinvolved.Theobjectiveoftheseguidelinesistoassistinensuringthequalityandintegrityofpharmaceuticalproductsduringallaspectsofthedistributionprocess.

对发生在经销环节的各项活动缺少足够的监督会影响药制品的质量。

此外，经销环节一般很少注重建立，发展，维持和控制活动的需要。

指导方针旨在确保发生在经销各个环节的药制品的质量和完整性

InordertomaintaintheoriginalqualityeveryactivityinthedistributionofpharmaceuticalproductsshouldbecarriedoutaccordingtotheprinciplesofGMP,goodstoragepractice（GSP）andgooddistributionpractice（GDP）.Althoughtheseguidelinesareintendedtobeastand-alonetexttheydonotdealwithallaspectsincludedinthestandardsforthestorageofpharmaceuticalswhicharecoveredinthe“WHOguidetogoodstoragepracticesforpharmaceuticals”（WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations.Thirty-seventhReport.Geneva,WorldHealthOrganization,2003（WHOTechnicalReportSeries,No.908,Annex9））.Itshouldalsobereadinconjunctionwithotherguidelinessuchas“WHOgoodmanufacturingpractices:

mainprinciples”（WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations.Thirty-seventhReport.Geneva,WorldHealthOrganization,2003（WHOTechnicalReportSeries,No.908,Annex4））;“GuidelinesforimplementationoftheWHOCertificationSchemeonthequalityofpharmaceuticalproductsmovingininternationalcommerce（WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations.Thirty-fourthReport.Geneva,WorldHealthOrganization,1996（WHOTechnicalReportSeries,No.863,Annex10））;"WHOpharmaceuticalstarting

materialscertificationscheme（SMACS）"（WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations.Thirty-eighthReport.Geneva,WorldHealthOrganization,2004（WHOTechnicalReportSeries,No.917,Annex3））;andthe"Guidelinesonimportproceduresforpharmaceuticalproducts"（WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations.Thirty-fourthReport.Geneva,WorldHealthOrganization,1996（WHOTechnicalReportSeries,No.863,Annex12））.

为了维持原有质量，要根据GMP，GSP和GDO的准则执行药制品经销环节的每一活动。

虽然这些指导方针是独立文本，但是但是它们不涉及药品存储标准里的所有方面，药品存储标准涵盖在《WHO对药品良好存储规则》的指南里（关于药制品配置规格的WHO专家委员会，第三十七号报告，Geneva,世界健康组织，2003（WHO科技报告系列No.908,Annex9）））。

我们应连同其他指导方针一起参阅如：

《WHO良好制造规则：

主要准则》（关于药制品配置规格的WHO专家委员会，第三十七号报告，Geneva,世界健康组织，2003（WHO科技报告系列No.908,Annex4）））；《对走向国际市场的药制品质量执行WHO检定计划的方针》（关于药制品配置规格的WHO专家委员会，第三十四号报告，Geneva,世界健康组织，1996（WHO科技报告系列No863,Annex10））；《WHO药业原料认证计划》（关于药制品