风险管理在胱抑素C校准品研发过程中的初步应用

发布时间：2018-05-20 09:45

本文选题：胱抑素C校准品 + 风险管理　；参考：《中国科学院大学(工程管理与信息技术学院)》2013年硕士论文

【摘要】：本文在分析我国医疗器械生产企业实施风险管理现状和问题的基础上,以胱抑素C校准品的研发实证为例,探讨了将国际标准IS014971应用于产品研发过程中的具体实施方法,为提升产品的安全性提供思路。本文通过文献查阅、专家咨询、实证研究,以胱抑素C校准品研发过程中实施的风险管理为例,梳理了对体外诊断试剂进行风险管理的流程,明确了生产企业在产品设计开发阶段、产品上市后及异常情况下需要具体实施的风险管理活动；详细介绍了体外诊断试剂研制过程中实施的风险分析的方法,探讨了如何按照风险控制的要求和风险控制方案对产品进行风险控制的方法。研究结果表明：北京万泰德瑞诊断技术有限公司(以下简称万泰德瑞公司)通过对胱抑素C校准品在研制过程中进行有效的风险管理,确保了该校准品的安全有效性,为该产品获得北京市食品药品监督管理审批的注册证书提供质量保障,使该产品在市场上替代DAK0公司的胱抑素C校准品成为可能。目前万泰德瑞公司的胱抑素C校准品,在市场上产品质量优势明显,有较好的口碑,其销售也取得了良好的的经济效益。总之本文以胱抑素C校准品研发阶段的风险管理为例,探讨了体外诊断试剂产品研制过程中具体的风险管理应用,总结该产品风险管理的经验,期望能为同行业厂家产品的研制时的风险管理工作提供一些经验。
[Abstract]:On the basis of analyzing the current situation and problems of implementing risk management in medical device manufacturing enterprises in China, this paper discusses the concrete implementation methods of applying international standard IS014971 to product development by taking the research and development of cystatin C calibrator as an example. To improve the safety of products to provide ideas. In this paper, through literature review, expert consultation, empirical research, taking the risk management of cystatin C calibration product as an example, the process of risk management of in vitro diagnostic reagent is combed. The risk management activities that need to be carried out in the stage of product design and development, after the product going on the market and under abnormal circumstances are clarified, and the methods of risk analysis in the development of in vitro diagnostic reagents are introduced in detail. This paper discusses how to carry out risk control according to the requirement of risk control and the method of risk control. The results show that: Beijing Wantaideri Diagnostic Technology Co., Ltd. (hereinafter referred to as Wantaideri Company) through the development of cystatin C calibration product through effective risk management, to ensure the safety and effectiveness of the calibration, Quality assurance is provided for the registration certificate approved by Beijing Food and Drug Administration, which makes it possible for the product to replace DAK0's cystatin C calibrator in the market. At present, the cystatin C calibrator of Vantaideri Company has obvious advantages of product quality and good reputation in the market, and its sales have also achieved good economic benefits. In a word, taking the risk management of cystatin C calibration product as an example, this paper discusses the application of risk management in the development of in vitro diagnostic reagent, and summarizes the experience of risk management in the product. It is expected to provide some experience for the risk management of product development in the same industry.
【学位授予单位】：中国科学院大学(工程管理与信息技术学院)
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F426.72;F272.3

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