| 麻疹-腮腺炎-风疹联合减毒活疫苗无菌生产工艺风险评估 |
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| 引用本文： | 欧阳楠,薛志革.麻疹-腮腺炎-风疹联合减毒活疫苗无菌生产工艺风险评估[J].国际生物制品学杂志,2020,43(2):82-84. |
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| 作者姓名： | 欧阳楠 薛志革 |
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| 作者单位： | 云南省食品药品监督管理局药品和医疗器械审评中心，昆明 650106；云南省药品监督管理局药品化妆品生产监管处，昆明 650106 |
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| 摘 要： | 目的 评价国产麻疹-腮腺炎-风疹联合减毒活疫苗(麻腮风疫苗)的无菌生产工艺风险。方法 应用质量风险管理的原则,使用失效模式和效果分析的风险管理工具评估确定麻腮风疫苗生产工艺中所有可能存在的质量问题和潜在风险。采用定量方法,计算风险系数,对此进行风险评估。结果 风险评估后各工艺环节的风险系数均小于40。结论 麻腮风疫苗无菌生产工艺风险可控,可不采取措施。
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| 关 键 词： | 麻疹-腮腺炎-风疹疫苗 无菌生产工艺 风险评估 |
Risk assessment for aseptic process of measles,mumps and rubella combined live attenuated vaccine |
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| Ouyang Nan,Xue Zhige.Risk assessment for aseptic process of measles,mumps and rubella combined live attenuated vaccine[J].International Journal of Biologicals,2020,43(2):82-84. |
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| Authors: | Ouyang Nan Xue Zhige |
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| Institution: | Center for drug and Medical Device Evaluation, Yunnan Province Food and Drug Administration, Kunming 650106, China; Drug and Cosmetic Supervision Division, Yunnan Pronvince Food and Drug Administration, Kunming 650106, China
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| Abstract: | Objective To evaluate the risk of aseptic processing of domestic measles, mumps and rubella combined live attenuated vaccine (MMR vaccine). Methods Failure mode and effect analysis, as the risk management tool, was used to assess and identify all possible quality issues and potential risks during the production process of MMR vaccine according to the principles of quality risk management. The risk priority number (RPN) was calculated by quantitative method and the risk was evaluated. Result Risk assessment showed that RPNs of all processing steps were less than 40. Conclusion The risks of aseptic processing of MMR vaccine are controllable,and reauire no further action. |
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| Keywords: | Measles-mumps-rubella vaccine Aseptic processing Risk assessment |
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