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| 浅谈生物制品生产用原辅材料的质量控制 | |
| 引用本文： | 洪小栩,佘清. 浅谈生物制品生产用原辅材料的质量控制[J]. 中国药品标准, 2007, 8(4): 17-20 |
| 作者姓名： | 洪小栩 佘清 |
| 作者单位： | 国家药典委员会,北京,100061 |
| 摘 要： | 目前,生物制品的安全性和有效性正在引起社会公众的更广泛关注,而生物制品制造过程中所使用的原辅材料的质量对制品的安全性和稳定性有着直接的影响。因此,加强对此类原辅材料的质量控制对提高生物制品的质量将起到重要作用。 |
| 关 键 词： | 生物制品 原材料 辅料 |
| 文章编号： | 1009-3656（2007）-4-17-4 |
Discussions on the Control of Source and Auxiliary Materials for the Production of Biologics |
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| Hong Xiao-xu and She Qing. Discussions on the Control of Source and Auxiliary Materials for the Production of Biologics[J]. , 2007, 8(4): 17-20 | |
| Authors: | Hong Xiao-xu and She Qing |
| Affiliation: | Chinese Pharmacopoeia Commission,Belting 100061 |
| Abstract: | At present,people show more concerns on the safety and efficacy of biological products.The quality of source and auxiliary materials used during manufacturing process may impact the safety and stability of the biological products directly.Therefore improving the quality of source and auxiliary materials will be one of the key points to ensure the safety and efficacy of biological products. |
| Keywords: | Biologics Source materials Auxiliary materials |
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