| 中国、欧盟对原料药GMP检查方面的比较 |
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| 引用本文： | 魏传波,颜丽萍,窦学杰. 中国、欧盟对原料药GMP检查方面的比较[J]. 中国药事, 2011, 25(2): 184-186 |
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| 作者姓名： | 魏传波 颜丽萍 窦学杰 |
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| 作者单位： | 山东新华制药股份有限公司,淄博,255000 |
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| 摘 要： | 目的借鉴欧盟在原料药GMP检查方面的成功经验,促进中国对药品的GMP监管。方法分析了中国、欧盟在原料药GMP检查方面的差异以及造成差异的原因。结果与结论随着我国新版GMP即将颁布实施,在认证标准上我们与欧盟几乎一致,但还需不断营造GMP成长的外围环境。
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| 关 键 词： | 原料药 GMP 欧盟 现场检查 差异比较 |
Differences Analysis on GMP Inspection between China and EU |
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| Wei Chuanbo,Yan Liping,Dou Xuejie. Differences Analysis on GMP Inspection between China and EU[J]. Chinese Pharmaceutical Affairs, 2011, 25(2): 184-186 |
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| Authors: | Wei Chuanbo Yan Liping Dou Xuejie |
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| Affiliation: | Wei Chuanbo,Yan Liping and Dou Xuejie(Shandong Xinhua Pharmaceutical Co.,Ltd,Zibo 255000) |
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| Abstract: | Objective To use the successful experiences on GMP inspection of EU,and promote the GMP supervision level of China.Methods To analyze the differences on GMP inspection between EU and China,and summarize the reasons.Results and Conclusion New GMP will be issued soon which is in line with the EU GMP,however we should focus on cultivating the outside environment in order to accelerate GMP growth. |
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| Keywords: | GMP |
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