| 王彦泽,罗标,张毅.安国市专营批发企业实施新修订GSP存在的问题及对策[J].中国药事,2018,32(6):719-723 |
| 安国市专营批发企业实施新修订GSP存在的问题及对策 |
| Problems and Countermeasures in Implementing Newly Revised GSP in Pharmaceutical Wholesale Enterprises in Anguo City |
| 投稿时间：2017-06-09 |
| DOI：10.16153/j.1002-7777.2018.06.004 |
| 中文关键词: 新修订GSP 分析 缺陷项目 |
| 英文关键词: newly revised GSP analysis defective items |
| 基金项目: |
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| 中文摘要: |
| 目的：通过探讨企业实施新修订《药品经营质量管理规范》（GSP）过程中存在的问题并找到解决问题的措施和办法，为科学有效实施新修订GSP提供建议。方法：对185家次企业现场检查报告中发现的缺陷项条款进行统计，分析安国市药品批发企业存在的主要问题，并提出相应的措施和办法。结果与结论：药品经营企业应当加强培训，制定符合企业实际经营情况的质量管理体系文件，并切实参与验证及做好对委托运输单位质量保障能力的审计等工作；政府应该出台健全的人才引进机制；药品监督管理部门应加强GSP认证检查员的培训，提高检查员的现场检查专业素质，从而确保新修订GSP正确贯彻实施。 |
| 英文摘要: |
| Objective:To explore the problems in the process of implementing the newly revised Good Supply Practice (GSP) and to find out countermeasures and methods to the problems in order to provide references for the scientific and effective implementation of the revised GSP. Methods:The defective items found in the on-site inspection reports from 185 enterprises/times were collected in order to analyze the main problems of pharmaceutical wholesale enterprises in Anguo City and to put forward corresponding measures and methods. Results and Conclusion:The pharmaceutical wholesale enterprises should strengthen staff training, draw up the quality management system documents suitable for the actual operation of the enterprises, and effectively participate in the verification and the auditing of the quality assurance ability of the entrusted transportation units. The government should introduce a sound mechanism for introducing talents. Moreover, the drug administration departments should strengthen the training of certified GSP inspectors and improve the on-site inspection professional quality of the inspectors so as to ensure the correct implementation of the newly revised GSP. |
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