血液制品批签发机构非检验环节样品管理浅析  被引量:1

Analysis on the Management of Non-inspection Link Samples in Blood Product Batch Issuing Institution

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作  者:袁惠 徐菲 夏红英 周雷罡 李敏 董文南 YUAN Hui;XU Fei;XIA Hongying;ZHOU Leigang;LI Min;DONG Wennan(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China;Center for Administrative Services and Complaints&Reports of JXNMPA,Nanchang Jiangxi 330029,China)

机构地区:[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029 [2]江西省药品监督管理局行政受理与投诉举报中心,江西南昌330029

出  处:《药品评价》2024年第3期274-277,共4页Drug Evaluation

基  金:江西省药品监督管理局科研项目(2022GL05)。

摘  要:通过跟踪血液制品从批签发申请开始进入批签发机构至销毁的非检验环节流转过程,分析在血液制品管理过程中可能影响质量的关键风险点,对各环节提出精确要求。建立从血液制品的受理、流转、留样及销毁各环节的科学规范的管理制度,增强血液制品批签发机构管理的科学性,保障批签发结果的准确可溯,为批签发机构消除血液制品在非检验环节管理方面可能出现的风险提供参考依据。By tracking the flow of blood products from the batch issuance application to the batch issuing agency to the non-inspection link,the key risk points that may affect the quality of blood products in the management process were analyzed,and precise requirements were put forward for each link.Establish a scientific and standardized management system for the acceptance,circulation,sample retention and destruction of blood products,enhance the scientific management in blood product batch issuing institutions,and ensure the accurate traceability of batch issuing results.This paper provides a reference basis for batch issuing institutions to eliminate the possible risks in the management of blood products in non-inspection links.

关 键 词:血液制品 批签发 非检验环节 样品管理 

分 类 号:R95[医药卫生—药学]

 

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