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| 冻干制剂生产过程中质量风险分析及控制要点 | |
| 引用本文： | 王新全,许文东,唐娜. 冻干制剂生产过程中质量风险分析及控制要点[J]. 齐鲁药事, 2011, 30(9): 548-549 |
| 作者姓名： | 王新全 许文东 唐娜 |
| 作者单位： | 山东齐都药业有限公司,山东,淄博,255400 |
| 摘 要： | 介绍冻干粉针剂生产过程中存在的质量风险,通过控制生产过程中的管理要点,加强过程控制,将质量问题消除在生产过程中,从而提高非最终灭菌制剂的无菌保证水平和降低其他质量风险. |
| 关 键 词： | 冻干粉针剂 质量风险 管理细节 |
Quality risk analysis and control points in the production process of freeze-dried preparation |
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| WANG Xin-quan,XU Wen-dong,TANG Na. Quality risk analysis and control points in the production process of freeze-dried preparation[J]. qilu pharmaceutical affairs, 2011, 30(9): 548-549 | |
| Authors: | WANG Xin-quan XU Wen-dong TANG Na |
| Affiliation: | WANG Xin-quan,XU Wen-dong,TANG Na(Shandong Qidu Pharmaceutical Co.,Ltd.,Zibo 255400,China) |
| Abstract: | Quality risks in the production process of freeze-dried powder injection were introduced,Through controlling the management in the production process and strengthening the process control,quality problems would be eliminated in production process,so as to improve the level of sterilization of final preparations and to lower other quality risks. |
| Keywords: | Freeze-dried powder injection Quality risk Management details |
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