现阶段我国GMP制度有效实施的关键因素研究及其制度设计

1摘要研究目的我国GMP制度已取得阶段性进展，对提高我国药品生产企业的管理水平、提高药品质量、保证人民用药安全有效有着深远的意义。但GMP的实施和发展是一项长期的任务，在其发展过程中也存在一些问题，本文研究的目的在于总结经验和存在的问题，分析其根源，提出建议，以期对下一阶段我国药品GMP的实施和发展提供参考依据。研究内容本文对发达国家GMP产生、发展、完善的历程进行了回顾和研究，通过实例分析，对比论证，对我国的GMP发展和实践做了全面和系统的分析阐述，以辨证的观点看待目前我国GMP实施以来所取得的成绩，总结存在的问题，客观而深刻地剖析了存在问题的根源，希望通过借鉴发达国家的实践经验，有针对性地提出了新时期我国药品GMP实施和发展的建议。研究方法本文利用理论及文献研究法和行动研究法，通过收集有关资料，回顾国内外GMP发展历程，分析我国目前GMP制度管理的现状，总结我国药品生产企业中目前存在的问题。运用“胜任力”理论，借鉴先进国家成熟经验的基础，集合笔者本身的工作实践，提出进一步完善我国GMP制度的新思路和新方法。成果和结论本文认为当前影响GMP实施的主要因素在于制药企业内部的人员系统问题；政府部门GMP检查员队伍建设不足，GMP制度相关的法律法规和技术标准体系不完善等原因。因此本文应用胜任力理论，针对我国当前GMP实施中存在的问题，提出一系列建议：制定并完善制药企业人员规划、获取与配置指标，加强和完善制药企业中培训和效果评估。同时根据笔者自身工作实践，从政府的角度提出：完善政府GMP检查员队伍建设；加快新技术、新工艺在药品GMP实施过程中的应用，强化质量风险管理意识，加强部门协调、强化监管队伍建设，不断深化推进质量受权人和驻厂监督员制度等建议。希望通过上述论述，加强社会各界对GMP制度的交流，促进GMP实施的工作。关键词：药品GMP；胜任力；有效实施；研究2AbstractResearchofSignificantFactorofGMPtoEffcetivemoveandItsDesignofSysteminCurrentStageGMPsysteminChinahasmadeprogressonimprovingChina'spharmaceuticalcorporationmanagementlevel,toimprovedrugqualityandensuresafetyandefficacyofthepeople.However,theimplementationanddevelopmentofGMPisalong-termtask,duringitsdevelopmentprocessstillhavesomeproblems.Thisstudyaimstosummarizeexperienceandanalysistheproblem,andproposetherecommendations,togetthereferencefornextphaseoftheGMPimplementationanddevelopment.ThroughreviewandresearchthehistoryofGMPproduction,developmentandimprovementofUSAandJapan,basedoncasestudies,comparativedemonstrationoftheGMPdevelopmentandpracticeofChinamadeacomprehensiveandsystematicanalysisofexpositiontodialecticalseeninperspectiveGMPimplementationinChinahasbeenachieved,summarizedtheproblems,deeplyanalysisthesourceoftheproblem,learnfromthepracticalexperienceofdevelopedcountries,putsforwardtheneweraofChinadrugGMPimplementationanddevelopmentofrecommendations.Inthispaper,throughmethodoftheoryandliteraturestudyandactionresearch,bycollectingrelevantinformation,reviewdomesticandinternationalGMPdevelopmenthistory,analysisofthecurrentstatusofGMPsystemmanagement,summarizedChina'spharmaceuticalcorporationexistingproblems,baseoncompetencetheory,learnfromtheexperiencesofadvancedcountries,thefoundationofacollectionoftheauthor'sownworkpractices,GMPsystemputforwardtoimprovenewideasandnewmethods.Inmyopinion,themainfactorsaffectingtheimplementationofGMPisthepharmaceuticalcorporation'sinternalstaffissues;theConstructionofgovernmentdepartmentslackofGMPinspectors,GMPsystemofrelevantlawsandregulationsandtechnicalstandardsforsystemimperfectionsandotherreasons.Thisarticle3appliedcompetencetheory,forourcurrentproblemsintheimplementationofGMP,proposedaseriesofrecommendations:todevelopandimprovethepharmaceuticalcorporationandpersonnelforstaffplanningandconfigurationindicatorsandstrengthenandimprovethetrainingandtheeffectofpharmaceuticalevaluation.Atthesametime,accordingtotheauthor'sownworkpractices,fromthestandpointoftheGovernment:ImprovingtheGovernmentConstructionofGMPinspectors;tospeedupnewtechnologyandnewcraftsimplementationprocessinthepharmaceuticalapplicationofGMP,andstrengthenthequalityofriskmanagementawarenessandstrengthendepartmentcoordination,andstrengtheninstitutionofqualitypersonandsupervisorofpharmaceuticalcorporation.Throughthispaper,theimplementationofGMPinChinainthenewperiodprovidesagoodreference.Keywords:DrugGMP;competence;effectiveimplementation;study1目录第一章导论...............................................................................................................11.1选题背景及其意义...........................................................................................11.1.1选题背景.................................................................................................11.1.2研究意义.................................................................................................21.2研究方法...........................................................................................................31.2.1理论及文献研究法.................................................................................31.2.2行动研究法.............................................................................................31.3研究目的...........................................................................................................41.4论文基本结构...................................................................................................4第二章胜任力基本理论.............................................................................................52.1胜任力概念的提出...........................................................................................52.2胜任力的界定...................................................................................................52.3胜任力的主要内容...........................................................................................62.4胜任力的分类...................................................................................................82.5胜任力模型.......................................................................................................92.6胜任力理论应用在药品GMP实施中的分析..............................................10第三章发达国家GMP制度发展情况...............