| 引用本文: | 张平,王元,沈泓,颜若曦.进口人血白蛋白境外生产现场检查分析与探讨[J].中国现代应用药学,2024,41(18):67-71. |
| Zhang Ping,Wang Yuan,Shen Hong,Yan Ruoxi.Discussion on the Inspection of Overseas Production Sites for Human Albumin[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(18):67-71. |
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| 摘要: |
| 本文采用数据库查询、文献综述和境外检查实证研究相结合的方法,以进口人血白蛋白现状及相关生产现场检查情况为研究对象,重点对近10年来进口人血白蛋白境外检查缺陷进行分类分布统计和典型缺陷分析,探讨境外血液制品企业生产质量管理共性问题并提出相关建议,为境外企业持续提升生产质量管理水平提供参考,为进一步强化对相关进口人血白蛋白的检查实效提供借鉴。 |
| 关键词: 人血白蛋白 境外检查 药品生产质量管理 |
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| Discussion on the Inspection of Overseas Production Sites for Human Albumin |
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Zhang Ping1, Wang Yuan1, Shen Hong2, Yan Ruoxi1
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1.Center for Food and Drug Insepection of NMPA,Beijing;2.Zhejiang Institute for Food and Drug Control,Hangzhou
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| Abstract: |
| ABSTRACT: Based on the combination of database query, literature review and empirical research on overseas inspection, this paper takes the current overview of imported human albumin and the inspection of related production sites as the research object, focuses on the classification and distribution of overseas inspection defections of imported human blood albumin in the past 10 years, as well as the typical defections. Discuss the common observations of production quality management of overseas blood product enterprises, and puts forward relevant suggestions, so as to provide reference for overseas enterprises to continuously improve the production quality management level and provide reference for further strengthening the effectiveness of the related inspection of imported human albumin. |
| Key words: human albumin, overseas inspection, drug manufacturing quality management |
