| 微生物检验替代法的验证概述 |
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| 引用本文： | 郝京京,颜喜亚,赵谦,邹莹. 微生物检验替代法的验证概述[J]. 中国药品标准, 2007, 8(2): 9-12 |
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| 作者姓名： | 郝京京 颜喜亚 赵谦 邹莹 |
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| 作者单位： | 1. 华北制药华胜有限公司,石家庄,052160
2. 凯默斯医药科技(上海)有限公司,上海,200040 |
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| 摘 要： | 本文介绍了工艺分析技术（PAT）中微生物替代法在制药业的应用领域，相关方法的类别以及其开发应用的意义。文章详细对比了美国药典1223和欧洲药典5．1．6对于微生物替代法验证要求的异同。为国内企业应用新技术提供了参考，同时还讨论了PAT相关理念的重要意义。
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| 关 键 词： | 微生物替代法 验证 |
| 文章编号： | 1009-3656（2007）-2-9-4 |
Introduction of Validation of Alternative Microbiological Methods |
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| Hao Jing-jing,Yan Xi-y,Zhao Qian and Zou Ying. Introduction of Validation of Alternative Microbiological Methods[J]. , 2007, 8(2): 9-12 |
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| Authors: | Hao Jing-jing Yan Xi-y Zhao Qian Zou Ying |
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| Affiliation: | 1.North China Pharmaceutical Huasheng Co. , Ltd., Shijiazhuang 052160; 2.Chemuerth Pharmaceutical Technology(Shanghai |
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| Abstract: | This article introduced the types,application field and meanings of alternative microbiological methods in the pharmaceutical industry,which is a key component part of Process Analysis pechnology(PAT).The authors compared the validation requirements for alternative microbiological methods between USP 1223 and Ph Eur 5.1.6 in detail.This article also supplied a reference to Chinese Pharmaceutical Industry to validate related new technology and discussed the meaning of PAT application for Chinese Pharmaceutical Industry. |
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| Keywords: | PAT |
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