| 黄炳生,李卓襄,张征,吴生齐.新《药品管理法》实施后广东省GSP跟踪检查情况分析[J].中国药事,2021,35(6):646-657 |
| 新《药品管理法》实施后广东省GSP跟踪检查情况分析 |
| Analysis of GSP Follow-up Inspections in Guangdong Province after the Implementation of the New Drug Administration Law of the People's Republic of China |
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| DOI：10.16153/j.1002-7777.2021.06.006 |
| 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 inspections defective items analysis |
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| 中文摘要: |
| 目的：分析新《药品管理法》实施后广东省GSP跟踪检查中发现的共性问题，为药品监管部门制定有针对性的监管措施提供参考。方法：对GSP跟踪检查中发现的缺陷项目进行统计，分析企业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GSP跟踪检查中共发现178 项缺陷项目，其中，缺陷项目主要分布在药品储存与养护(17.98%)、质量管理体系文件(16.85%)、 人员与培训(15.73%)、设施与设备(13.48%)、质量管理体系(7.87%)5个方面。企业应当提高培训的针对性和实效性，加强质量管理体系文件的管理，充分发挥质量管理在各环节的作用，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 common problems discovered during the Good Supply Practice (GSP) follow-up inspections in Guangdong after the implementation of the new Drug Administration Law of the People's Republic of China and to provide references for making regulatory measures. Methods: The defective items found during the follow-up inspections were analyzed. The main problems and possible causes in quality management system of the drug distribution enterprises were also analyzed, and the corresponding countermeasures were proposed. Results and Conclusion: 178 defective items were found during the follow-up inspections. The defective items were mainly divided into five aspects: drug storage and maintenance (17.98%), quality management system documents (16.85%), personnel and training (15.73%), facilities and equipment (13.48%), and quality management systems (7.87%). The drug wholesale enterprises should make training more specific and effective, strengthen the management of quality management system documents, make full use of the quality management in all aspects and continuously improve and perfect the quality management system. |
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