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
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.
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引用本文复制引用
基金项目
江西省药品监督管理局科研项目(2023GL25)
江西省卫生健康委科技项目(202311142)
江西省中医药局科技项目(2020B0370)
出版年
2024
国家科技期刊平台
NSTL
万方数据