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| 广东省药品批发企业新版GSP跟踪检查情况分析 |
| Analysis of Situation of Drug Wholesale Enterprises of Guangdong Province Under New Edition of GSP Follow-up Inspection |
| 投稿时间：2020-03-20 修订日期：2020-05-26 |
| DOI： |
| 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: |
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| 中文摘要: |
| 目的: 分析2018年～2019年期间广东省药品批发企业实施新版《药品经营质量管理规范》(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。结果与结论：部分药品批发企业在药品储存与养护、设施与设备、计算机管理系统、温湿度监测系统、人员与培训等方面还存在不足,企业应当持续不断地改进和完善质量管理体系；提高培训的针对性和实效性。 |
| 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 of 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: There were still some deficiencies in the following aspects in the part of drug wholesale enterprises: drug storage and maintenance, facilities and equipment, computer management system, temperature and humidity monitoring system, as well as personnel and training. The drug wholesale enterprises should continuously improve and perfect quality management system and make training more specific and effective. |
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