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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.
17、6 ThedutiesoftheQualifiedPcrson(三)arcdescribedinArticle51ofDirective2I83EC.andcanbesummarisedasfollows:QP的贡任在2(X)183EC第51款中已有描述，可以归纳如下a)formedicinalproductsmanufacturedwihintheEuropeanUnion,aQualifiedPersonmustensurethateachbatchhasbeenmanufacturedandcheckedincompliancewiththelawsinforceinthatMember
18、Slateandinaccordancewiththerequirementsofthemarketingaulhorisalion2;在欧共体之内生产的药品，必需有一具备资格人员QP，保证毋批产品均依据其所在成员国法规和上市许可的要求进行生产和检查。(b)inthecaseofnelicinalprandpracticeofthequalitymanagementsystemandGoodManufacturingPractice,newlyrcc11itcdpersonnelshouldreceivetrainingappropriatetothedutiesassignedtothem.
19、Continuingtrainingshouldalsobegiven,anditspracticaleffectivenessshouldbeperiodicallyassessed.Trainingprogrammesshouldbeavailable,approvedbyeithertheheadofPnxluctionortheheadofQualityControl,asapppriatc.Trainingrecordsshouldbekepi.对新进的人员除了进行GMP的理论和实践方面的基本培训外，还要进行与所担当的工作干脆相关的培训。培训应当是一项持续进行的工作，并须要定期对培训
20、的结果进行评估。应制定培训安排，并由生产负贡人或质量负贵人批准。培训活动要进行记录。2.12 Personnelworkinginareaswherecontaminationisahazard,e.g.cleanareasorareaswherehighlyactive,toxic,infectiousorsensitisingmaterialsarehandled,shouldbegivenspecifictraining.在污染商危区域工作的人员，如干净区或处理高活性、毒性、感染或过敏性材料的区域，须要进行特殊培训。2.13 Visitorsoruntrainedpersonnelsho
21、uld,preferably,notbetakenintotheproductionandqualitycontrolareas.Ifthisisunavoidable,theyshouldbegiveninformationinadvance,particularlyaboutpersonalhygieneandtheprescribedprotectiveclothing.,ITieyshouldbecloselysupervised.参观人员和未经培训的人员，最好不嘤进入生产区或质量限制区，假如不行避开,他们必需事先进行培训，特殊是针对人先干净和个人防护用品的运用方面。同时陪伴他们进行亲
22、密指导.2.14 Thepharmaceuticalqualitysystemandallthenwasurcscapableofimprovingitsunderstandingandimplementationshouldbefullydiscussedduringthe(miningsessions.对药品质量体系的概念，和全部其他有助于理解和应用的方法，都应当在培训中进行全面的探讨。PersonnelHygiene人员卫生2.15 Detailedhygieneprogrammesshouldbeestablishedandadaptedtothedifferentneedswithi
23、nthefactory。Theyshouldincludeproceduresrelatingtothehealth,hygienepracticesandclothingofpersonnel.TheseproceduresshouldbeunderstoodandfollowedinaverystrictwaybyCVCrypersonwhosedutiestakehimintotheproductionandcontrolareas.Hygieneprogrammesshouldbepromotedbymanagementandwidelydiscussedduringtrainings
24、essions.应建立具体的卫生清洁程序，适用于工厂的各种须要。应包括健康、清洁方法和工作服运用方面的操作程序。在生产区或侦量限制区工作人员必需对这些程序理解并严格执行，I1生规程必需由管理乂进行审定，并在培训过程中进行广泛的探讨。2.16 Allpersonnelshouldreceivemedicalexaminationuponrecruitment.Itmustbethemanufacturersresponsibilitythattherearcinst11ctionsensuringthathealthconditionsthatcanbeofrelevancetothequali
25、tyofproductscometo(hemanufacturersknowledge.Afterlhcfirstmedicalexaminationexaminationsshouldbecarriedoutwhennecessaryfortheworkandpersonalhealth.全部人员在入职时均应进行健康检查。牛.产商必需依据自Cl的产品状况，制定相关的人员卫生要求。在首次健康检查之后，还要在工作须要的时候或个人健康状况须要的时候进行检查。2.17 Stepsshouldbetakentoensureasfarasispracticablethatnopersonaffected
26、byaninfectiousdiseaseorhavingopenlesionsontheexposedsurfaceofthebodyisengagedinthemanufactureofmedicinalproducts.实行有效的防卫措施，保证参加药品牛产人员没有传染病和体表暴露伤口。2.18 Everypersonenteringthemanufacturingareasshouldwearprotectivegarmentsappropriatetotheoperationstobecarriedout.全部进入生产区域的人员均应若与生产悚作相适当的防护性工作服2.19 Eating
27、,drinking,chewingorsmoking,orthestorageoffood,drink,smokingmaterialsorpersonalmedicationintheproductionandstorageareasshouldbeprohibited.Ingeneral,anyunhygienicpracticewithinthemanufacturingareasorinanyotherareawheretheproductmightbeadverselyaffectedshouldbeforbidden.禁止在生产区域和仓贮区域吃东西、喝饮料、喷东西和吸烟，存贮食品、
28、饮料、吸烟用品，个人药用品。殷，在生产区域和其它全部其它相关区域应禁止出现一切不卫生，可能会对产品产生不良影响的东西。2.20 Directcontactshouldbeavoidedbetweentheoperatorshanisandtheexposedproductaswellaswithanypartoftheequipmentthatcomesir11ocontactwiththeproducts.操作人员应避开裸手操作产品，以及会与产品干脆接触的全部设法部件2.21 PersonnelshouldbeinstructedtouseIhehand-washingfacilities.
29、要对人员进行洗手设施运用方面的培训。2.22 Anyspecificrequirementsforthemanufactureofspecialgroupsofproducts,forexamplesterilepreparations,arecoveredintheannexes.全部对特定类别产品，例如无菌制剂，的特定生产要求在附件中说明Consultants顾问2.23 Consultantsshouldhaveadequateeducation,(raining,andexperience,oranycombinationthereof,toadviseonthesubjectforw
30、hichtheyarcretained.顾问应在其所指导的主题范围内具仃足够的教化、培训和阅历,或兼具上述要求。Recordsshouldbemaintainedstatingthename,address,qualifications,andIyPCofserviceprovidedbytheseconsultants.应保留相关记录，说明顾问的姓名、地址、资质，以及供应的服务类型。111Article55ofl)irective2OO1/82/EC2AccordingtoArticle51paragraphIofDirective2()()l83ECithebelchesofmedicinalPrOdUCKwhichhaveundergonesuchcontrolsinaMemberStaleshallbeexemptfromthecontrolsiftheyaremarketedinanotherMemberState,accom)anie(lbythecontrolreportssignedbylhequ川ijkdpe”om.怅据2(X)1/83EC笫51款第1段，在某一成分国依据其耍求进行限制的药品批次，假如随货有QP整名的限制报告，在另一成员国上市，则在上市国的限制要求可以免除.3Hicie53OfDirective2001/82/EC
