| 浅谈接受美国FDA现场检查的体会 |
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| 引用本文： | 毛燕群,马淑涛. 浅谈接受美国FDA现场检查的体会[J]. 齐鲁药事, 2012, 31(4): 244-245,248 |
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| 作者姓名： | 毛燕群 马淑涛 |
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| 作者单位： | 1. 山东大学药学院,山东,济南,250012山东新华制药股份有限公司,山东,淄博,255005
2. 山东大学药学院,山东,济南,250012 |
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| 摘 要： | 本文介绍了美国FDA现场检查的目的和检查程序,讲解了FDA现场检查的迎审对策,包括现场检查的基本原则,文件和现场准备,有效组织迎审团队,认真研究审核思路,加强GMP意识培养,历史检查问题的整改。
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| 关 键 词： | 美国食品药品监督管理局 现场检查 迎审对策 现行药品生产质量管理规范 |
Experience and understanding of countermeasures for FDA site inspection |
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| MAO Yan-qun , MA Shu-tao. Experience and understanding of countermeasures for FDA site inspection[J]. qilu pharmaceutical affairs, 2012, 31(4): 244-245,248 |
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| Authors: | MAO Yan-qun MA Shu-tao |
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| Affiliation: | 1. School of Pharmacy, Shandong University, Jinan 250012, China ;2. Shandong Xinhua Pharmaceutical Co. , Ltd. , Zibo 255005, China ) |
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| Abstract: | This article gave an introduction of the purpose and the procedure of FDA site inspection and described the countermeasures for FDA site inspection, including the basic principles of FDA site inspection, documents and site preparation, how to efficiently organize the team for the inspection, carefully study on the train of FDA inspector＇s thinking, enhancement of GMP awareness and corrections of the historical findings. |
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| Keywords: | FDA Site inspection Countermeasures for inspection CGMP |
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