首页|全面风险管理视角下冷链药品经营企业质量体系研究

全面风险管理视角下冷链药品经营企业质量体系研究

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目的 探讨质量控制体系在冷链药品风险管控中的作用。方法 根据《药品经营质量管理规范现场检查指导原则》条款,分析影响冷链药品储运质量的关键因素和存在的问题,并提出改进措施。结果 与结论 冷链药品经营企业通过构建完善的质量体系,可实现冷链药品的全过程不断链,保障用药安全。
Research on the Quality System of Cold Chain Pharmaceutical Trading Enterprises from the Perspective of Comprehensive Risk Management
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.

comprehensive risk managementquality management systemcold chain drugssafeguard measures

曾文辉、黄文平、杨民荣

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江西省药品检查员中心,江西 南昌 330001

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

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

全面风险管理 质量管理体系 冷链药品 保障措施

江西省药品监督管理局科研项目江西省卫生健康委科技项目江西省中医药局科技项目

2023GL252023111422020B0370

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(11)
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