围产期干细胞库质量管理体系构建  

Construction of quality management system for perinatal stem cell banks

作　　者：汪德海 李天君 高建恩 于磊 张桂福 马旭 Wang Dehai;Li Tianjun;Gao Jian’en;Yu Lei;Zhang Guifu;Ma Xu(National Research Institute for Family Planning,Beijing 100081,China)

机构地区：[1]国家卫生健康委科学技术研究所

出　　处：《中华细胞与干细胞杂志（电子版）》2019年第5期309-313,共5页Chinese Journal of Cell and Stem Cell（Electronic Edition）

基　　金：国家重点研发计划（2017YFC1002004,2016YFC1000307-11）

摘　　要：围产期干细胞库质量管理体系(QMS)建设是保障干细胞产品和服务健康发展的基础工作。本文比较分析美国输血协会(AABB)、细胞疗法认证基金会(FACT)和ISO 9001的标准的架构、内容和侧重点,重点论述围产期干细胞库QMS构建的方法、步骤和参考模式。参照权威机构标准建立和运行QMS,能够保障我国围产期干细胞库标准化、规范化和科学化的建设和管理,提升我国干细胞库能力和信任水平。良好的QMS进一步促进干细胞与精准医疗战略性新兴产业升级,为建设健康中国提供动力。Constructing a quality management system(QMS)is the basic part to ensure the quality of the stem cell products and the development of service.By comparing the structure,content and emphasis of standards established by American Association of Blood Banks(AABB),Foundation for the Accreditation of Cellular Therapy(FACT)and ISO9001,this article discusses the methods,steps and reference model of constructing a QMS for stem cell banks.It not only helps ensure the construction and managment of perinatal stem cell banks are standardized,normalized and scientific by reference these standards,but also helps improve the ability and level of trust of banks.A good QMS can also accelerate the promotion of strategic emerging industries like stem cells and precision medicine,and provide the motive force to build healthy China.

关 键 词：围产期 干细胞库 质量管理体系 构建 改进 

分 类 号：F20[经济管理—国民经济]