| 青海省藏药生产企业新修订药品GMP认证检查缺陷项目分析与对策研究 |
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| 引用本文： | 韩达斌,刘学良,潘平,陈鹏,俞雅琼,刘海青. 青海省藏药生产企业新修订药品GMP认证检查缺陷项目分析与对策研究[J]. 中国药事, 2017, 31(1): 32-36 |
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| 作者姓名： | 韩达斌 刘学良 潘平 陈鹏 俞雅琼 刘海青 |
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| 作者单位： | 青海省食品药品监督管理局食品药品审评中心, 西宁 810007,青海省食品药品监督管理局食品药品审评中心, 西宁 810007,青海省食品药品监督管理局食品药品审评中心, 西宁 810007,青海省食品药品监督管理局食品药品审评中心, 西宁 810007,青海省食品药品监督管理局食品药品审评中心, 西宁 810007,青海省食品药品监督管理局食品药品审评中心, 西宁 810007 |
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| 摘 要： | 目的：对青海省GMP认证检查过程中发现的缺陷项进行汇总，以供业内借鉴和参考。方法：对青海省内13家藏药生产企业GMP认证现场检查中发现的质量保证方面存在的缺陷进行统计分析。结果与结论：绝大多数药品生产企业对于新修订的药品GMP理解不够充分，执行不到位。应进一步完善相应的质量管理体系，更有效地控制产品潜在的风险，保证药品质量。
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| 关 键 词： | 药品GMP 现场检查 缺陷 质量管理体系 |
| 收稿时间： | 2016-06-23 |
Analysis and Countermeasures on Inspected Defects in Newly Revised Drug GMP Certification in Tibetan Medicine Enterprises of Qinghai Province |
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| Han Dabin,Liu Xueliang,Pan Ping,Chen Peng,Yu Yaqiong and Liu Haiqing. Analysis and Countermeasures on Inspected Defects in Newly Revised Drug GMP Certification in Tibetan Medicine Enterprises of Qinghai Province[J]. Chinese Pharmaceutical Affairs, 2017, 31(1): 32-36 |
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| Authors: | Han Dabin Liu Xueliang Pan Ping Chen Peng Yu Yaqiong Liu Haiqing |
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| Affiliation: | Food and Drug Review Center of Qinghai Food and Drug Administration, Qinghai, Xining 810007, China,Food and Drug Review Center of Qinghai Food and Drug Administration, Qinghai, Xining 810007, China,Food and Drug Review Center of Qinghai Food and Drug Administration, Qinghai, Xining 810007, China,Food and Drug Review Center of Qinghai Food and Drug Administration, Qinghai, Xining 810007, China,Food and Drug Review Center of Qinghai Food and Drug Administration, Qinghai, Xining 810007, China and Food and Drug Review Center of Qinghai Food and Drug Administration, Qinghai, Xining 810007, China |
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| Abstract: | Objective: To summarize the defects in the process of revising GMP certification in Qinghai Province, so as to provide references for the industry. Methods: The quality defects in the field inspection of GMP certifiction of 13 Tibetan medicine enterprises in Qinghai Province were analyzed and classified. Results and Conclusion: Most drug manufacturers don''t understand the new quality assurance items in revised drug GMP fully and implement completely. They still need to improve their quality management system gradually to reduce the potential risk of products more effectively. |
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| Keywords: | drug GMP field inspection defect quality management system |
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