广东省药品经营企业冷链管理现场检查情况分析

Analysis of the On-site Inspection of Cold Chain Management of Drug Management Enterprises in Guangdong Province

目的:分析研究广东省药品经营企业冷链管理的情况,为药品经营企业冷链管理工作的有效开展提供参考和思路,同时也为药品经营企业监管及检查工作中对冷链管理方面的针对性检查提供借鉴。方法:本文通过对2018-2020年广东省药品经营企业检查过程中发现的有关冷链管理常见问题的梳理和分类,以及对药品经营企业冷链验证管理现场检查发现的相关问题的探讨,提出相关建议。结果与结论:加强药品冷链管理能够规避冷藏药品储存和运输过程中的质量安全风险。企业通过更新管理理念、加强人员管理和培训、加大设施设备的投入、加强冷链各环节的质量控制、健全管理制度以及落实质量管理责任,有助于保障冷链管理药品的质量。

Objective: To analyze the situation of cold-chain management in drug-trading enterprises of Guangdong Province with the aim to provide references and ideas for the effective development of cold-chain management and provide references for the targeted inspection of cold-chain management in the supervision and inspection work of drug-trading enterprise. Methods: The common problems found in cold-chain management during the GSP on-site inspections of drug-trading enterprise of Guangdong Province between 2018 and 2020 were sorted out and classified. Related problems found during the on-site inspection of cold-chain verification management of drug-trading enterprises were discussed and some relevant suggestions were put forward. Results and Conclusion: The quality and safety risk during the storage and transportation of refrigerated drugs could be avoided through strengthening drug cold-chain management. The drug-trading enterprises should update the management philosophy, strengthen management and personnel training, increase the investment of facilities and equipment, strengthen the quality control of each link of cold chain medicine, improve the management system,and implement quality management responsibility, which helps to guarantee the quality of cold chain management drugs.