EU-GMP指南-第1部分第2章-人员.docx

EUROPEANCOMMISSIONHEA1.THANDCONSUMERSDIRECTORATE-GENERA1.PublicHealthandRiskAssessmentMedicinalProduct-quality,safetyandefficacyBrussels.16August2013Eudra1.exTheRulesGoverningMedicinalProductsintheEuropeanUnionVolume4EUGuidelinesforGoodManufacturingPracticeforMedicinalProductsforHumanandVeterinaryUsePart1ChaDter2:PerSonnel人药与兽药GMP指南第2章：人员Ixigalbasisforpublishingthedetailedguidelines:Article47ofDirective2(X)I83EContheCommunitycoderelatingtomedicinalproductstorhumanuseand/Xrticle51ofDirective200l82EContheCommunitycoderelatingtoveterinaymedicinalproducts.Thisdocumentprovidesguidancefortheinterpretationoftheprinciplesandguidelinesofgoodmanufacturingpractice(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原则和指南的说明。Statusofthedocument:Revision文件状态：修订Reasonsforchanges:Changeshavebeenmadeinordertointegratetheprinciplesof"PharmaceuticalQualitySystem"asdescribedintheICHQIOtripartiteguideline.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:16February2014实施最终期限：2014年2月160Principle原则ThecocctmanufactureofmedicinalProdUCISreliesuponpeople.Forthisreasontheremustbesufficientqualifiedpersonneltocarryoutallthetaskswhicharetheresponsibilityofthemanufacturer.Individualresponsibilitiesshouldbeclearlyunderstoodbytheindividualsandrecorded.AllpersonnelshouldbeawareoftheprinciplesofGOodManufacturingPracticethataffectthemandreceiveinitialandcontinuingtraining,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 Themanufacturershouldhaveanadequatenumberofpersonnelwiththenecessaryqualificationsandpracticalexperience.Seniornanagenenshoulddetermineandprovideadequateandappropriateresources(human,financial,materials,facilitiesandequipmeni)toimplementandmaintainthequalitymanagementsystemandcontinuallyimproveitseffectiveness.Ilieresponsibilitiesplacedonanyoneindividualshouldnotbesoextensiveastopresentanyrisktoquality.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,QualityControlandwhereapplicableHeadofQualityAssuranceorQualityUnitreferredtoinpoint2.5andthepositionoftheQualifiedPCrSOn(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 PeoPIeinresponsiblepositionsshouldhavespecificdutiesrecordedinwrittenjobdescriptionsandadequateauthoritytocarryouttheirresponsibilities,"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，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,communicatedandimplementedth11>ughouttheorganisation.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()I83EC1).anadequatenumber,butatIeaStone.QualifiedPerson(三)designatedforthepurpose.Normally,keypostsshouldbeoccupiedbyfull-tinwpersonnel.TheheadsofProductionandQualityControlmustbeindependentfromeachother.Inlargeorganisations,itmaybenecessarytodelegatesomeofthefunctionslistedin2.6and2.7.AdditionallydependingonIhcsizeandorganizationalst11clurcofthecompany,aseparateHeadofQualityAssunmccorHeadoftheQualityUnitmaybeappointed.WhereSUChafunctionexistsusuallysomeoftheresponsibilitiesdescribedin2.6.2.7and2.8aresharedwiththeHeadOfQuaIiiyControlandIleadofProductionandseniormanagementshouldthereforetakecarethatroles,res<nsibiities,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.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,aQualifiedPersonmustensurethateachbatchhasbeenmanufacturedandcheckedincompliancewiththelawsinforceinthatMemberSlateandinaccordancewiththerequirementsofthemarketingaulhorisalion2;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)inthecaseofne<licinalpr<xluclscomingfromthirdcountries,irrespectiveofwhethertheproducthasbeenmanufacturedintheEuropeanUnionaQualifiedPersonmustensurethateachproductionbatchhasundergoneinaMemberStateafullqualitativeanalysis,aquantitativeanalysisofatleastalltheactivesubstancesandalltheothertestsorchecksnecessarytoensurethequalityofmedicinalproductsinaccordancewiththerequirementsofthemarketingauthorisation.TheQualifiedPersonmustcertifyinaregisterorequivalentdocument,asoperationsarccarriedoutandbeforeanyrelease,thateachproductionbatchsatisfiestheprovisionsofArticle51.假如药品来源于欧共体之外的国家，不管该产品是否在欧共体内生产，Qp必需保证全部生产批次均在某个成员国接受了全面侦量检查，至少对全部活性物质进行了定量分析,进行了全部其它必要的检测或检查，以保证药品符合上市许可的要求。QP必需签发一份登记的文件或等同的文件，以保证在放行前全部操作均已完成，全部生产批准均满足第51款的要求。ThepersonsresponsibleforthesedutiesmustmeetthequalificationrequirementslaiddowninArticle493ofthesameDirective,theyshallbepermanentlyandcontinuouslyatthelisosalOfIheholderoftheManufacturingAuthorisationtocarryouttheirresponsibilities.上述职货负责人的资质应符合同样法令第49款中的要求，人员应在上市许可持有人公司长期持续行使其职交。TheresponsibilitiesofaQualifiedPersonmaybedelegated,butonlytootherQuali11edPerSOn(三).QP的职贪可以转授权，但只能是转授权给其它QPoGuidanceoneroleotheQualifiedPersoniselaboratedinAnnex16.QP的角色指南在附件16中说明。2.7TheheadoftheProductionDepartmentgenerallyhasthefollowingresponsibilities:生产部门负责人一般具有如下职责i. Toensurethatproductsareproducedandstoredaccordingtotheappropriatedocumentationinordertoobtaintherequiredquality;保证产品的生产和存贮符合适当的文件的要求，以获得所需的品质。ii. Toapprovetheinstructionsrelatingtoproductionoperationsandtoensuretheirstrictimplementation;批准与生产悚作有关的指令，保证其被严格遵守。iii. Toensurethattheproductionrecordsareevaluatedandsignedbyanauthorizedperson;保证生产记录由经授权的人足评估并签字.iv. Toensurethequalificationandmaintenanceofhisdepartment,premisesandequipment;保证生产部门、厂房设施和设备得到询认和维护。V.ToensurethatIheappropriatevalidationsaredone;保证已进行了适当的验证。vi.Toensurethattherequiredinitialandcontinuingtrainingofhisdepartmentpersonneliscarriedoutandadaptedaccordingtoneed.保证生产部门人员所需的初始和后续培训已实施，满足须要。2.8 TheheadOfQuaIityControlgenerallyhasthefollowingresponsibilities:质量限制负贲人一股具有如卜职贵i. Toapproveorreject,asheseesfit.startingmaterials,packagingmaterials,inte11nediae,bulkandfinished11xlucts;批准或拒收，由负贪人判定，起始物料、包装材料、中间体、散装和制剂成品。ii. Toensurethatallnecessarytestingiscarriedoutandtheassociatedrecordsevaluated:保证明施全部必需的测试，并对相关记录进行评价。iii. ToapproveSPeCifiCations.samplinginstructions,testmethodsandotherQualityControlprocedures：批准质量标准、取样指令、检验方法和其它质址限制程序。iv. Toapproveandmonitoranycontractanalysts;批准及监控全部合同分析人员v. Toensurethequalificationatdmaintenanceofhisdepartment,premisesandequipment;保证质量部门、设施和设备得到确认和维护vi. Toensurethattheappropriatevalidationsaredone;保证已进行适当的验证vii. Toensurethattherequiredinitialandcontinuingtrainingofhisdepartmentpersonneliscarriedoutandadaptedaccordingtoneed.保证质量部门人员所需的初始和后续培训已实施，满足须要。OtherdutiesofQualityControlaresummarisedinChapter6.质量限制的其它职贪在第6章中进行了归纳。2.9 TheheadsofProduction.QualityControlandwhererelevant.HeadofQualityAssuranceorHeadofQualityUnit,generallyhavesomeshared,orjointlyexercised,responsibilitiesrelatingtoqualityincludinginpa11icularthedesign,effectiveimplementation,monitoringandmaintenanceofthequalitymanagementsystem.Thesemayinclude,subjecttoanynationalregulations:生产部门、质量限制部门负责人，及质量保证或质做部门负责人（适当时），一般会共同担当，或联合进行一些与质量相关的职贡，包括侦址管理体系的设计、有效实施、监控和维护.这些职责可能会包括，受到全部国家法规的约束.i. Theauthorisationofwrittenproceduresandotherdocuments,includingamendments;书面程序和其它文件，包括修订内容的批准ii. Themonitoringandcontrolofthemanufacturingenvironment;生产环境的监控和限制iii.Planthygiene;工厂卫生iv. Processvalidation;工艺验证v. TnIining;培训vi. Theapprovalandmonitoringofsuppliersofmaterials;原料供应商的批准和监控vii. Theapprovalandnx)nitoringofcontractmanufacturersandprovidersofotherGMPrelatedoutsourcedactivities;对分包生产商和供应其它GMP相关外包服务供应商的批准和监控，viii. Tliedesignationandmonitoringofstorageconditionsformaterialsandproducts;原料和产品存贮条件的设计和监控ix. Theretentionofrecords;记录保存x. ThemonitoringofcompliancewiththerequirementsofGoodManufacturingPractice;GMP符合性监控xi. Theinspection,investigation,andtakingofsamples,inordertomonitorfactorswhichmayaffectproductquality;检查、调查和取样，以监控产品历量影响因素xii. Participationinmanagementreviewsofprocessperformance,productqualityandofthequalitymanagementsystemandadvocatingcontinualimprovement参加工艺性能、产品质S1.质加管理体系和倡议持续改进的管理评审xiii. Ensuringthatatimelyandeffectivecommunicationandescalationprocessexiststoraisequalityissuestotheappropriatelevelsofmanagement.保证刚好有效沟通，加强现有向适当级别管理房提出质量议施的通道Training培训2.1 ()Themanufacturershouldprovidetrainingforallthepersonnelwhosedutiestakethemintoproductionandstorageareasorintocontrollaboratories(includingthetechnical,maintenanceandcleaningPerSonneI),andforotherpersonnelwhoseactivitiescouldaffectthequalityoftheproduct.生产商应当给全部在生产和存贮区工作的人员和化险室工作的人包括技术人力、修理人后和清洁人员)以及其他工作行为可能会影响到产品质量的人田进行培训.2.11 Besidesthebasictrainingonthethcor>'andpracticeofthequalitymanagementsystemandGoodManufacturingPractice,newlyrcc11itcdpersonnelshouldreceivetrainingappropriatetothedutiesassignedtothem.Continuingtrainingshouldalsobegiven,anditspracticaleffectivenessshouldbeperiodicallyassessed.Trainingprogrammesshouldbeavailable,approvedbyeithertheheadofPnxluctionortheheadofQualityControl,asapp>priatc.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 Visitorsoruntrainedpersonnelshould,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 Detailedhygieneprogrammesshouldbeestablishedandadaptedtothedifferentneedswithinthefactory。Theyshouldincludeproceduresrelatingtothehealth,hygienepracticesandclothingofpersonnel.TheseproceduresshouldbeunderstoodandfollowedinaverystrictwaybyCVCrypersonwhosedutiestakehimintotheproductionandcontrolareas.Hygieneprogrammesshouldbepromotedbymanagementandwidelydiscussedduringtrainingsessions.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.Itmustbethemanufacturer'sresponsibilitythattherearcinst11ctionsensuringthathealthconditionsthatcanbeofrelevancetothequalityofproductscometo(hemanufacturer'sknowledge.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 Stepsshouldbetakentoensureasfarasispracticablethatnopersonaffectedbyaninfectiousdiseaseorhavingopenlesionsontheexposedsurfaceofthebodyisengagedinthemanufactureofmedicinalproducts.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,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、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 Directcontactshouldbeavoidedbetweentheoperator'shan<isandtheexposedproductaswellaswithanypartoftheequipmentthatcomesir11ocontactwiththeproducts.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.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,toadviseonthesubjectforwhichtheyarcretained.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