风险管理在药品批发企业冷链药品质量管理中的应用探讨
Exploration on the application of risk management in the quality management of cold chain drugs in pharmaceutical wholesale enterprises
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| DOI |
10.12208/j.ijmd.20250033 |
| 刊名 |
International Journal of Medicine and Data
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| 年，卷(期) |
2025, 9(2) |
| 作者 |
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| 作者单位 |
山东罗盛医药有限公司 山东临沂
|
| 摘要 |
冷链药品作为对温度高度敏感的一类特殊药品，其质量直接关系到临床疗效与患者用药安全。本文结合当前药品批发企业在冷链药品质量管理中面临的挑战，从硬件设施、人员能力、流程控制及应急管理等方面分析存在的风险点，并提出基于风险管理理念的质量控制策略。通过构建全链条风险管理体系、强化基础设施投入、优化人员培训机制和完善应急预案等措施，全面提升冷链药品的质量管理水平，为药品流通环节的风险防控提供理论支持和实践路径。
|
| Abstract |
As a special type of drugs highly sensitive to temperature, the quality of cold-chain drugs is directly related to clinical efficacy and patient medication safety. Combining the current challenges faced by pharmaceutical wholesale enterprises in the quality management of cold-chain drugs, this paper analyzes the risk points in terms of hardware facilities, personnel capabilities, process control, and emergency management, and proposes quality control strategies based on the concept of risk management. By constructing a full-chain risk management system, strengthening infrastructure investment, optimizing personnel training mechanisms, and improving emergency plans, the quality management level of cold-chain drugs is comprehensively improved, providing theoretical support and practical paths for risk prevention and control in pharmaceutical circulation links.
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| 关键词 |
风险管理；药品批发企业；冷链药品；质量管理；应用效果
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| KeyWord |
Cold-chain drugs; Pharmaceutical wholesale enterprises; Quality management; Risk control
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| 基金项目 |
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| 页码 |
66-66 |
刘姗姗*.
风险管理在药品批发企业冷链药品质量管理中的应用探讨 [J].
国际医学与数据杂志.
2025; 9; (2).
66 - 66.