《质量源于设计(QbD)指导原则在医疗器械研发中的实证研究_——层析式总胆固醇自测仪的研发项目管理》.docx

本文主要思考和讨论的内容是尝试将质量源于设计（Quality by Design，QbD）这 一理念和原则运用于一个全新的医疗器械产品研发的项目全程设计、跟踪、指导和管 理，以期获得将 QbD 落实于医疗器械研发的一些初步方法和成功或失败两方面的一 些基本经验，以及为今后进一步探索如何将 QbD 指导原则同医疗器械新产品研发相 结合建立一个初步的研究实例和方法学案例。相较于制药企业，国内的医疗器械（包括诊断试剂）企业对 GMP 理念和原则的 接受和推广得更晚，因而更需要有既符合科学实践原则又具有实际指导意义的新理念 和新方法来指导医疗器械产品（包括诊断试剂产品）的研发、生产和市场销售的各个 阶段。而 POCT（Point of Care Testing），国内目前通常译作即时检验或现场检验，作为 医疗器械产品中的一个特殊领域，近年来在国外，尤其是欧美市场取得了长足的发展， 但国内自上世纪九十年代中期开始引进和推广血糖仪产品及妊娠和尿试纸检测等少 数几个产品外，并无更多的产品推出，而临床和实际又有较广泛的应用和需要。本项目团队根据这一个情况，经过广泛的调研和认真的评估，提出了开发总胆固 醇（Total Cholesterol，TC）POCT 产品的计划和构想，并依据同期在北大 IPEM 学习 所获得的 QbD 相关知识、方法和经验，创新地尝试在项目启动初期即将正在国内外 制药领域推广应用的 QbD 的方法和原则运用于实际的产品研发全过程中。关键词：质量源于设计 医疗器械研发 即时检验 总胆固醇检测仪Title：A case of the application of QbD rules in the research and development of medical device----the analysis of project management of the instant total cholesterol kitABSTRACTIn this paper，the principle of QbD (Quality by Design) concept was discussed and applied in the whole research process of a new medical device(MD), including the design process, project tracking, guidance and management. It was expected to acquire some fundamental method and basic experience of both success and failure from the MD research, and also trying to establish an initial research example and a methodology case to discover how to combine the QbD rule with the development of MD product in the future.Compare to the pharmaceutical industry, the GMP principle was much later introduced and accepted to the medical device industry (including the diagnostic reagent industry) in China. So it is more necessary to bring new ideas and new methods which are both scientific, reasonable and practical to instruct the development of a new medical device product as anintegrated process，from research to manufacturing and to marketing of the final product.POCT as a short form of Point of Care Testing is a special area of MD products, which has made significant progresses on the U.S. and European market in recent decades. But in China, the popular products th