| 药品包材法规最新进展和疑难问题讨论 |
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| 引用本文： | 翟铁伟,丁恩峰,高海燕.药品包材法规最新进展和疑难问题讨论[J].医药工程设计,2013(6):63-68. |
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| 作者姓名： | 翟铁伟 丁恩峰 高海燕 |
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| 作者单位： | [1]国家食品药品监督管理局药品认证管理中心,北京100061 [2]英国施达化学集团公司中国代表处,河北石家庄050031 [3]北京赛铭医药科技有限公司,北京100054 |
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| 摘 要： | 汇总和分析了欧美药典对药品包材的技术要求，以及中国国家注册标准的现状；另外，对各国药品包材注册法规也做了比较和介绍。并结合FDA最新的关于药品包材相容性的指南，对玻璃包材进行了重点讨论。希望通过对药品包材质量标准和注册法规的介绍，可以为中国制药企业在此领域的研究有所帮助。
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| 关 键 词： | 药品包材 标准 美国药典 欧洲药典 El本药典 注册标准 洁净室 相容性 预灌封注射器 |
Discussion of Newest Development and Difficult Problems in Drug Packing Regulations |
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| Zhai Tiewei,Ding Enfeng,Gao Haiyan.Discussion of Newest Development and Difficult Problems in Drug Packing Regulations[J].Pharmaceutical Engineering Design,2013(6):63-68. |
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| Authors: | Zhai Tiewei Ding Enfeng Gao Haiyan |
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| Institution: | 1. Administration Center of Medicine Certification, State Food ＆ Drug Supervision and Administration Bureau, Beijing, 100061; 2. China Representative Office, Great Briton Shida Chemical Group Co., Shijiazhuang, 05003 l; 3. Beijing Spring PharmaTech Inc., Shijiazhuang, 100054) |
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| Abstract: | In this paper, the specification for drug packing in European and US pharmacopoeias as well as current situation of Chinese registration standard were summarized and analyzed. In addition, the registration codes for drug packing materials in various countries were introduced and compared. Then, combined with newest guidance on the compatibility of drug packing materials issued by FDA, the glass materials used in packing were discussed. It is hoped that the introduction of drug packing material standards and registration codes are helpful to Chinese pharmaceutical enterprises in carrying out the study in this field. |
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| Keywords: | drug packing standard USP EP JP registration specification cleaning room compatibility prefilled syringe |
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