我国药品生产过程中记录的计算机化研究

I摘要研究背景：研发生产记录计算机化系统在制药界的使用日趋广泛。由于业界对计算机化系统的验证缺乏理解，尽管药监机构不要求企业在药品生产过程中使用计算机化记录，但是如果使用计算机化记录作为生产管理的一种手段，就必须符合GMP的相关规定，因此形成了企业希望使用计算机化记录但是又不敢使用的尴尬局面。研究目的：通过对美国食品药品管理局Part11法规以及我国新版GMP的剖析，探索采用记录计算机化存在的难度以及法规局限性和技术限制性，建立计算机化系统验证Part11合规性分析方法，为企业在选择先进设备和提高企业信息化管理提供参考。研究方法：比较中美对计算机化记录管理的要求差异，归纳药企在记录管理上存在的问题，分析药品生产过程中使用计算机化记录的益处，调查计算机化记录在我国药企中的使用现状和动因，归纳性地建立Part11相关性评估和符合性验证的具体方法和步骤。研究结果和结论：企业通过提高自身的管理水平和工艺稳定性，培养专业技术团队，并采用符合自身实际需要的系统或项目实施策略，可通过使用计算机化系统来提高管理水平和竞争力。关键词：风险评估；21CFRPart11；计算机化记录；计算机化系统IIStudyonComputerizedRecordsinChinesePharmaceuticalSocietyAbstractBackground:Computerizedsystemsarebecomingmorewidelyusedinthedevelopmentandmanufacturinginpharmaceuticalindustry.Althoughelectronicrecordisnotrequiredtobeusedbytheregulatoryagencies,theelectronicrecordmustmeetGMPrequirementsifithasbeenusedasamethodforthemanufacturingmanagement;however,duetothelackofknowledgeofthevalidationofthecomputerizedsystem,theawkwardsituationthatthemanufacturerswanttousecomputersystembutdarenottousehasbeenformed.Objective:BasedontheanalysisofthePart11,CFR21inUSFDAandthenewversionofGMPinChina,thedifficultiesandlimitationsofthecomputerizedsystembothfromlegalperspectivesandtechnologicalperspectiveswereexploredtoestablishthecomplianceanalysismethodsaccordingtothePart11toprovidethereferencesforthemanufacturerstoselectadvancedequipmentandimprovethecomputerizedmanagementinthemanufacturers.Methods:TherequirementdifferencesintheelectronicrecordsinChinaandUSarecompared,andtheexistingproblemsinelectronicrecordsinthepharmaceuticalmanufacturersaresummedup,theadvantagesoftheelectronicrecordsinthemanufacturingprocessofthepharmaceuticalproductsareanalyzed,thecurrentsituationandtheincentivesfortheusingofelectronicrecordsinthedomesticpharmaceuticalmanufacturersaresurveyed,andthepracticalmethodandtheproceduresfortherelevanceevaluationandcompliancevalidationofthePart11areestablishedinductively.ResultsandConclusion:Manufacturerscanimproveitsmanagementlevelsandprocessstabilitythroughcultivationoftheprofessionalteamandadoptionofthesystemandprojectimplementationstrategiesthemeetthepracticalneeds,andcomputerizedsystemcanbeadoptedtoimprovethemanagementlevelandthecompetiveness.IIIKeywords:Riskassessment,21CFRPart11,Computerizedrecords,ComputerizedsystemIV目录第1章绪论...............................................................................................................................................11.1研究背景.......................................................................................................................................11.2研究的目的和意义.......................................................................................................................21.3基础知识.......................................................................................................................................21.3.1Part11概述.............................................................................................................................21.3.2PredicateRule..........................................................................................................................31.3.3计算机化系统........................................................................................................................4第2章研究设计.......................................................................................................................................62.1研究思路.......................................................................................................................................62.2研究方法.......................................................................................................................................6第3章研究结果.......................................................................................................................................73.1我国药品生产过程中使用计算机化记录的必要性分析.............................................................73.1.1GMP对于记录管理的要求....................................................................................................73.1.2目前我国药企在记录管理中存在的问题............................................................................73.1.3使用计算机化记录的必要性.................................................................................................93.2计算机化记录在我国药企中的使用现状与趋势.......................................................................103.2.1我国药企使用计算机化记录的现状..................................................................................103.2.2药监机构对计算机化记录的态度......................................................................................123.2.3新技术发展对记录计算机化的影响..................................................................................133.3影响计算机化记录使用的原因分析..........................................................................................143.3.1工艺的不成熟......................................................................................................................153.3.2系统验证的难度和成本......................................................................................................153.3.3技术人员不足.......