| 浅谈原料药年度质量回顾的编写方法 |
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| 引用本文： | 何晓梅,吴玉祥.浅谈原料药年度质量回顾的编写方法[J].医药工程设计,2010,31(5):21-24. |
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| 作者姓名： | 何晓梅 吴玉祥 |
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| 作者单位： | 南通精华制药股份有限公司,江苏,南通,226006 |
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| 摘 要： | 介绍了产品年度质量回顾在制药企业质量管理和GMP、FDA、COS迎接认证检查中的重要性,详细地介绍了如何编写原料药产品年度质量回顾。
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| 关 键 词： | 产品年度质量回顾 原料药 认证检查 |
Brief Discussion of Annual Review for Quality of Active Pharmaceutical Ingredients |
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| He Xiaomei,Wu Yuxiang.Brief Discussion of Annual Review for Quality of Active Pharmaceutical Ingredients[J].Pharmaceutical Engineering Design,2010,31(5):21-24. |
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| Authors: | He Xiaomei Wu Yuxiang |
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| Institution: | (Nantong Jinghua Pharmaceutical Co.,Ltd Nantong,226006) |
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| Abstract: | In this article,the importance of annual product quality review in pharmaceutical enterprise quality administration and certification inspection with GMP,FDA and COS was introduced,and the method of writing annual product quality review was also described in detail. |
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| Keywords: | annual product quality review pharmaceutical ingredients certification inspection |
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