文章摘要
黄炳生,张征,吴生齐.广东省药品批发企业GSP跟踪检查情况分析[J].中国药事,2020,34(6):625-631
广东省药品批发企业GSP跟踪检查情况分析
On Drug Wholesale Enterprises of Guangdong Province Under GSP Follow-up Inspection
投稿时间:2020-03-20  
DOI:10.16153/j.1002-7777.2020.06.002
中文关键词: 药品经营质量管理规范  跟踪检查  缺陷项目  分析
英文关键词: Good Supply Practice  follow-up inspection  defective items  analysis
基金项目:
作者单位
黄炳生 广东省药品监督管理局审评认证中心, 广州 510080 
张征 广东省药品监督管理局审评认证中心, 广州 510080 
吴生齐 广东省药品监督管理局审评认证中心, 广州 510080 
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中文摘要:
      目的: 分析2018-2019年期间广东省药品批发企业实施《药品经营质量管理规范》(Good Supply Practice,GSP)的情况以及在跟踪检查中发现的共性问题,为今后制定有针对性的监管措施和企业避免出现类似问题提供参考。方法: 对122家药品批发企业在跟踪检查中发现的缺陷项目进行统计,分析药品批发企业GSP质量体系存在的主要问题和原因,提出相应的解决措施和建议。结果与结论: 在对122家企业的GSP跟踪检查中共发现141项合计488条缺陷项目,缺陷项目主要分布在药品储存与养护(18.03%)、设施与设备(14.75%)、人员与培训(13.93%)、机构和质量管理职责(7.58%)、质量管理体系(7.17%)等5个方面。企业应当提高培训的针对性和实效性,加强质量管理体系的内审,充分发挥质量管理部在各环节的作用,并持续不断地改进和完善质量管理体系。
英文摘要:
      Objective: To analyze the situation and common problems discovered between 2018 and 2019 during the follow-up inspections of drug wholesale enterprises of Guangdong Province as the new Good Supply Practice (GSP) was implemented with the aim to provide references for making regulatory measures and avoiding similar problems. Methods: The defective items found during the follow-up inspections of 122 drug wholesale enterprises were analyzed. The main problems and possible causes in quality management system of the drug wholesale enterprises were also analyzed and the corresponding countermeasures were put forward. Results and Conclusion: In the GSP follow-up inspections of 122 drug wholesale enterprises, a total of 141 items, equal to 488 defective items were found, which were mainly distributed in five aspects, including drug storage and maintenance(18.03%), facilities and equipment(14.75%), personnel and training(13.93%), institutional and quality management responsibilities(7.58%), as well as quality management system(7.17%). The drug wholesale enterprises should improve the pertinence and effectiveness of the training, enhance quality management system internal verification, give full play to the role of the quality management department in all aspects and continuously improve and perfect quality management system.
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