药品批发企业冷链验证存在的问题及对策

目的:通过汇总分析药品批发企业冷链验证存在的问题及原因,找出规范冷链验证工作的对策,从而更好地保障冷链药品在储运过程的质量.方法:对2015～2020年湖北省药品批发企业的药品经营许可事项现场检查报告中"校准与验证"部分的缺陷项目进行汇总,分析药品批发企业冷链验证存在的问题及原因,提出相应的对策与方法.结果 与结论:药...

Problems and Countermeasures in Cold Chain Verification of Pharmaceutical Distribution Facilities

Objective: To sort out the countermeasures to standardize cold chain verification through a summary analysis of the problems and causes of cold chain verification in pharmaceutical distribution facilities, so as to better guarantee the quality of cold chain drugs in the storage and transportation process. Methods: The defective items in the "calibration and verification" part of the on-site inspection report of drug business licenses of pharmaceutical distribution facilities in Hubei Province from 2015 to 2020 were summarized, the problems and causes of cold chain verification of pharmaceutical distribution facilities were analyzed, and corresponding countermeasures and methods were proposed. Results and Conclusion: Pharmaceutical distribution facilities should take their main responsibilities and participate in the whole process of verification, including preparations before verification implementation, supervision during verification implementation, and review after verification implementation, to effectively implement the requirements of the GSP.