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全面风险管理视角下冷链药品经营企业质量体系研究

曾文辉 黄文平 杨民荣

中国药业2024,Vol.33Issue(11):21-24,4.
中国药业2024,Vol.33Issue(11):21-24,4.DOI:10.3969/j.issn.1006-4931.2024.11.005

全面风险管理视角下冷链药品经营企业质量体系研究

Research on the Quality System of Cold Chain Pharmaceutical Trading Enterprises from the Perspective of Comprehensive Risk Management

曾文辉 1黄文平 2杨民荣3

作者信息

  • 1. 江西省药品检查员中心,江西 南昌 330001
  • 2. 江西中医药大学中药固体制剂制造技术国家工程研究中心,江西 南昌 330006
  • 3. 江西省赣州市综合检验检测院食品药品检测所,江西 赣州 341000
  • 折叠

摘要

Abstract

Objective To investigate the role of quality control system in risk management of cold chain drugs.Methods According to the Guidelines for On-Site Inspection of Good Manufacturing Practice for Drug Operations,the key factors and existing problems that affect the quality of cold chain drug storage and transportation were analyzed,and improvement measures were put forward.Results and Conclusion The cold-chain pharmaceutical enterprises can achieve continuous supply chain throughout the entire process of cold chain drugs by constructing a perfect quality system,in order to ensure medication safety.

关键词

全面风险管理/质量管理体系/冷链药品/保障措施

Key words

comprehensive risk management/quality management system/cold chain drugs/safeguard measures

分类

医药卫生

引用本文复制引用

曾文辉,黄文平,杨民荣..全面风险管理视角下冷链药品经营企业质量体系研究[J].中国药业,2024,33(11):21-24,4.

基金项目

江西省药品监督管理局科研项目[2023GL25] ()

江西省卫生健康委员会科技计划项目[202311142] ()

江西省中医药管理局科技计划项目[2020B0370]. ()

中国药业

OACSTPCD

1006-4931

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