中国食品药品监管2024，Issue(1) ：76-81,中插22.DOI:10.3969/j.issn.1673-5390.2024.01.009

山东省药品经营企业记录与数据管理缺陷问题分析及监管建议

Analysis and Supervison Suggestions on the Problems of Records and Data Management in Drug Distributors in Shandong Province

李海峰 侯玉磊 赵彩虹 张艳 王帅 庄辉
中国食品药品监管2024，Issue(1) ：76-81,中插22.DOI:10.3969/j.issn.1673-5390.2024.01.009
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  • 维普
  • 万方数据

山东省药品经营企业记录与数据管理缺陷问题分析及监管建议

Analysis and Supervison Suggestions on the Problems of Records and Data Management in Drug Distributors in Shandong Province

李海峰 1侯玉磊 1赵彩虹 1张艳 1王帅 1庄辉1
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作者信息

  • 1. 山东省食品药品审评查验中心
  • 折叠

摘要

药品安全关系公众的生命健康,药品经营过程中的数据对药品流通质量安全和可追溯具有重要意义.笔者对2023年所在单位承担的255家次监督检查任务中发现的药品经营企业记录与数据管理方面存在的缺陷进行了归类分析,以期客观真实地反映药品经营企业在合规性方面存在的问题.同时,结合日常检查工作实际对出现缺陷问题的原因进行分析,为相关企业提升质量管理水平提供参考,为药品监管部门提升监管能力提出建议.

Abstract

Drug safety is vital for public health,and the data generated during the drug management process holds significant importance for the safety and traceability of drug circulation.This article classifies and analyzes defects in the record and data management of pharmaceutical trading enterprises discovered during 255 supervision and inspection tasks undertaken by our unit in 2023.The aim is to objectively and accurately reflect the compliance issues existing in these enterprises.By analyzing the reasons behind the identified defects in daily inspection work,we provide references for enterprises to improve their quality management,and offer suggestions for drug regulatory authorities to improve their regulatory capabilities.

关键词

药品经营企业/记录与数据管理/缺陷分析/监管/建议

Key words

pharmaceutical trading enterprise/records and data management/defect analysis/supervision/suggestions

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出版年

2024
中国食品药品监管
中国医药报社

中国食品药品监管

影响因子：0.099
ISSN：1673-5390
参考文献量10
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