对我国体外诊断试剂质量管理体系考核中发现问题统计分析.pdf

Chinese Journal of Medical Instrumentation 2012 年36 卷第6 期 监 管 与 测 试 文章编号：1671-7104(2012)06-0433-05 对我国体外诊断试剂质量管理体系 考核中发现问题的统计分析 【作 者】 田少雷 国家食品药品监督管理局药品认证管理中心，北京市，100061 【摘 要】 目的 了解我国体外诊断试剂生产质量管理体系的整体水平和存在的主要问题和薄弱环节。方法 对国家食品药品监督管理局 药品认证管理中心2011年下半年组织的体外诊断试剂企业的质量管理体系考核现场检查发现的问题进行了统计分析。结论 我国体外诊断试剂生产质量管理体系水平近年有较大的提升但仍存在较多问题，其主要薄弱环节是文件和记录控制、设计控 制和验证、生产过程控制和检验与质量控制等，应当作为我国体外诊断试剂企业质量管理体系完善和监管的重点内容。 【关 键 词】体外诊断试剂；质量管理体系；问题；统计分析 【中图分类号】R446.11+9 【文献标志码】A doi:10.3969/j .issn.1671-7104.2012.06.010 Statistical Analysis on Findings in the Quality Management System During Inspection of IVD Manufactures of China 【Writer 】Tian Shaolei Center for Certification of Drug, State Food and Drug Administration, Beij ing, 100061 【Abstract 】Objective To explore the current state and the mainly typical problems and vulnerable parts existed in the quality management systems (QMS) of local in vitro diagnostic reagent manufactures. Method To statistical analyze the problems found in the quality management system of in vitro diagnostic reagent manufactures through inspection organized by CCD, SFDA during the second half year of 2011. Results The total level of the QMS of local IV D manufacturers has risen greatly in past recent years, but a lot of problems still existed. The main vulnerable issues existed in QMS of IVD are documentation and recorder control, design control and validation, producing process control, as well as monitoring and quality control etc, to which should be paid more attention in the future improvement made by the enterprises and supervision by the administration authorities. 【 】 Key words in vitro diagnostic reagent, quality m