EU-GMP指南-第1部分第2章-人员.docx

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1、EUROPEANCOMMISSIONHEA1.THANDCONSUMERSDIRECTORATE-GENERA1.PublicHealthandRiskAssessmentMedicinalProduct-quality,safetyandefficacyBrussels.16August2013Eudra1.exTheRulesGoverningMedicinalProductsintheEuropeanUnionVolume4EUGuidelinesforGoodManufacturingPracticeforMedicinalProductsforHumanandVeterinaryUs

2、ePart1ChaDter2:PerSonnel人药与兽药GMP指南第2章：人员Ixigalbasisforpublishingthedetailedguidelines:Article47ofDirective2(X)I83EContheCommunitycoderelatingtomedicinalproductstorhumanuseand/Xrticle51ofDirective200l82EContheCommunitycoderelatingtoveterinaymedicinalproducts.Thisdocumentprovidesguidancefortheinterpre

3、tationoftheprinciplesandguidelinesofgoodmanufacturingpractice(GM11)formedicinalproductsaslaiddowninDirective2003/94,ECformedicinalproductsforhumanuseandDirective91/412/EECforVeIerinaryuse.指南细则出版的立法基的：2(X)I83EC法令第47款对人用药品的相关婴求.2001/82/EC法令第51款善用药相关的欧共体法规.本文件主要是20O3/94/EC法令对人用药和9I/4I2/EEC时善用药品的GMP原则和指

4、南的说明。Statusofthedocument:Revision文件状态：修订Reasonsforchanges:ChangeshavebeenmadeinordertointegratetheprinciplesofPharmaceuticalQualitySystemasdescribedintheICHQIOtripartiteguideline.Asectionhasbeenaddedonconsultants变更理由：变更是为了整合ICHQlo三方协调指南中所描述的“药品质量体系”的原则。增加了顾问部分。Deadlineforcomingintoperation:16Februar

5、y2014实施最终期限：2014年2月160Principle原则ThecocctmanufactureofmedicinalProdUCISreliesuponpeople.Forthisreasontheremustbesufficientqualifiedpersonneltocarryoutallthetaskswhicharetheresponsibilityofthemanufacturer.Individualresponsibilitiesshouldbeclearlyunderstoodbytheindividualsandrecorded.Allpersonnelshoul

6、dbeawareoftheprinciplesofGOodManufacturingPracticethataffectthemandreceiveinitialandcontinuingtraining,includinghygieneinst11ctions,relevanttoihcirneeds.药品的正确生产依靠于人。因此，生产商应配备足够的仃资质的人员担当全部工作。全部员工应明确个人应担当的职员并有书面记录。全部人员应明白与其职贪相关的GMP的原则，接受初始及后续培训，包括与其工作相关的卫生要求。General通则2.1 Themanufacturershouldhaveanade

7、quatenumberofpersonnelwiththenecessaryqualificationsandpracticalexperience.Seniornanagenenshoulddetermineandprovideadequateandappropriateresources(human,financial,materials,facilitiesandequipmeni)toimplementandmaintainthequalitymanagementsystemandcontinuallyimproveitseffectiveness.Ilieresponsibiliti

8、esplacedonanyoneindividualshouldnotbesoextensiveastopresentanyrisktoquality.生产商应具符足够数量的人力，人田应具德必变的资质和实践阅历。高匕管理应确定和供应足够的和适当的资源(人员、经济、物料、厂房设施和设备)，以实现和维护质量管理体系，并持续提高其有效性。给单个人员的职费不应太多，造成对质量的风险“2.2 Themanufacturermusthaveanorganisationchartinwhich(herelationshipsbetweentheheadsofProduction,QualityControl

9、andwhereapplicableHeadofQualityAssuranceorQualityUnitreferredtoinpoint2.5andthepositionoftheQualifiedPCrSOn(三)arcclearlyshowninthemanagerialhierarchy.生产商必需具备组织机构图，依据2.5内容在其中标明牛.产负贵人、QC负贪人和QA或质量部门负货人的关系，QP的位竟应在管理层级中明确标示。2.3 PeoPIeinresponsiblepositionsshouldhavespecificdutiesrecordedinwrittenjobdescr

10、iptionsandadequateauthoritytocarryouttheirresponsibilities,11eirdutiesmaybedelegatedtodesignateddeputiesofasatisfactoryqualificationlevel,!hereshouldbenogapsorunexplainedoverlapsintheresponsibilitiesofthosePerSonnelconcernedwiththeapplicationofGoodManufacturingPractice.担当职货的人m应具有指定的任务，任务应在书面岗位职贡中记录，

11、并具备足够的权限实现其职贡.其职责可以转授予具有令人满足的资所以次的人员.与实施GMP相关人员的职贵之间不应有漏项或无法说明的重叠.2.4 Seniormanagementhastheultimateresponsibilitytoensureaneffectivequalitynanagcmcntsystemisinplacetoachievethequalityobjectives,and,thatroles.responsibilities,andauthoritiesaredefined,communicatedandimplementedth11ughouttheorganisati

12、on.SeniortnanagenentshouldestablishaqualitypolicythatdescribestheoverallintentionsanddirectionofthecompanyrelatedtoqualityandshouldensurecontinuingsuitabilityandeffectivenessofthequalitymanagementsystemandGMPcompliancethroughparticipationinmanagementreview.高层管理对保证具备质量管理体系以达到质量目标具有最终职货，其角色、职责、权限应在组织范

13、围内进行定义、沟通和实施.高层管理应建立质址方针,在其中描述公司整体质量相关意图和方向，应通过参加管理评审保证质fit管理体系持续适用和有效性，保证GMP符合性.KeyPersonnel关健人员2.5 SeniorManagementshouldappointKeyManagementPersonnelincludingtheheadofProduction,theheadofQualityControl,andifatleastoneofthesepersonsisnotresponsibleforthedutiesdescribedinArtiCle51ofDirective2O()I83

14、EC1).anadequatenumber,butatIeaStone.QualifiedPerson(三)designatedforthepurpose.Normally,keypostsshouldbeoccupiedbyfull-tinwpersonnel.TheheadsofProductionandQualityControlmustbeindependentfromeachother.Inlargeorganisations,itmaybenecessarytodelegatesomeofthefunctionslistedin2.6and2.7.Additionallydepen

15、dingonIhcsizeandorganizationalst11clurcofthecompany,aseparateHeadofQualityAssunmccorHeadoftheQualityUnitmaybeappointed.WhereSUChafunctionexistsusuallysomeoftheresponsibilitiesdescribedin2.6.2.7and2.8aresharedwiththeHeadOfQuaIiiyControlandIleadofProductionandseniormanagementshouldthereforetakecaretha

16、troles,resnsibiities,andauthoritiesaredefined.高层管理应任命关键管理人员，包括牛.产负贵人、QC负货人，假如这些人中的至少一个不担当2oo83EC第51款中描述的职责，则应有足够数址，至少一个人应任命为QP。一般来说，关键岗位应由全职人员担当。生产和QC负责人必需相互独立。暇如组织机构浩大，可能须要任命2.6和2.7中所列的职责人员。另外，依据各公司规模和组织结构不同，可能须要分别任命QA或QU负责人。假如存在这种功能，一般2.6,2.7和2.8中描述的职贡会由QC负责人和生产负费人分担，高U管理则须要保证时这些职位的角色、贡任和权限进行定义“2.6 ThedutiesoftheQualifiedPcrson(三)arcdescribedinArticle51ofDirective2I83EC.andcanbesumma