| 谈谈FDA对原料药的GMP现场检查 |
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| 引用本文： | 吕冬梅,史玮.谈谈FDA对原料药的GMP现场检查[J].中国药事,2010,24(9):917-918. |
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| 作者姓名： | 吕冬梅 史玮 |
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| 作者单位： | 华北制药集团爱诺有限公司,石家庄,052165 |
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| 摘 要： | 目的浅析FDA对原料药的GMP现场检查。方法针对FDA关于原料药GMP现场检查的重点进行详细论述和分析。结果与结论企业如果建立了有效的GMP制度,那么企业完全能够通过FDA的认证。
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| 关 键 词： | FDA 原料药 GMP现场检查 |
Analysis of FDA Inspection on GMP Conformance for the Manufacturing of Active Pharmaceutical Ingredients |
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| Lv Dongmei,Shi Wei.Analysis of FDA Inspection on GMP Conformance for the Manufacturing of Active Pharmaceutical Ingredients[J].Chinese Pharmaceutical Affairs,2010,24(9):917-918. |
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| Authors: | Lv Dongmei Shi Wei |
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| Institution: | (North China Pharmaceutical Group Aino Co.,Ltd.,Shijiazhuang 052165) |
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| Abstract: | Objective To provide an analysis of FDA inspection on GMP conformance for the manufacturing of active pharmaceutical ingredients （APIs）.Methods To carry out specific discussions and analysis focusing on FDA inspection on GMP conformance for the manufacturing of active pharmaceutical ingredients （APIs）. Results and Conclusion If enterprises have set up effective GMP system,an approval form FDA inspection would be safely assured. |
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| Keywords: | FDA |
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