| 注射用水系统质量控制的难点及对策 |
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| 引用本文： | 沈继武,张跃鑫,龙海亭,王峰. 注射用水系统质量控制的难点及对策[J]. 机电信息, 2013, 0(2): 8-10 |
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| 作者姓名： | 沈继武 张跃鑫 龙海亭 王峰 |
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| 作者单位： | 中国医学科学院北京协和医学院医学生物学研究所,云南昆明,650118 |
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| 摘 要： | 结合《药品生产质量管理规范（2010年修订）》（以下简称新版GMP）、《中国药典》2010版的相关标准、规范与要求，以注射用水为研究对象，分析、研究注射用水系统质量控制中存在的问题及难点，阐述注射用水系统质量保证与质量控制的对策。
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| 关 键 词： | 注射用水 质量保证 质量控制 GMP |
Quality control of water for injection system: difficulties and Countermeasures |
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| Shen Jiwu , Zhang Yuexin , Long Haiting , Wang Feng. Quality control of water for injection system: difficulties and Countermeasures[J]. Mechanical and Electrical Information, 2013, 0(2): 8-10 |
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| Authors: | Shen Jiwu Zhang Yuexin Long Haiting Wang Feng |
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| Affiliation: | Shen Jiwu Zhang Yuexin Long Haiting Wang Feng (Chinese academy of medical sciences,Beijing union medical college institute of medical biology,Kunming 650118,China) |
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| Abstract: | This paper, ＂Good Manufacturing Practices for Drugs （Revised 2010） ＂（hereinafter the new version of GMP）,the version of＂ Chinese Pharmacopoeia＂ standard,specification and requirement,water for injection as the object of study, analysis, study the quality of water for ihjeetion system problems and difficulties in the control of water for injection system of quality assurance and quality control countermeasures. |
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| Keywords: | water for inj ection quality assurance quality control Good Manufacturing Practices for Drugs （GMP） |
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