| 金晶,管昱州,黄蕾,胡晶,陈慧,李凌.药品批发企业冷链验证存在的问题及对策[J].中国药事,2021,35(4):428-432 |
| 药品批发企业冷链验证存在的问题及对策 |
| Problems and Countermeasures in Cold Chain Verification of Pharmaceutical Distribution Facilities |
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| DOI：10.16153/j.1002-7777.2021.04.010 |
| 中文关键词: 冷链验证 药品批发企业 质量负责人 |
| 英文关键词: cold chain verification pharmaceutical distribution facilities the head of quality control |
| 基金项目:湖北省药品监督管理局2018-2019年度科研立项及资助项目(鄂食药监办函[2018] 19号)：药品批发企业冷链验证关键风险点的研究(编号 201801019) |
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| 中文摘要: |
| 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：药品批发企业应发挥主体责任，参与验证的全过程，包括验证实施前的准备工作、验证实施时的监督工作、验证实施后的审核工作，切实落实《药品经营质量管理规范》要求。 |
| 英文摘要: |
| 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. |
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