| 摘要: |
| 布鲁氏菌病（布病）活疫苗是世界各国防控布病的重要生物资源，我国目前主要生产和应用的布病活疫苗为S2株和A19株。生物安全是布病活疫苗生产过程中的必须优先考虑的重要环节，随着兽药GMP（2020年版）的即将实施，规范布病活疫苗的生产与检验，防控生产环节中的生物安全风险，成为迫切需要研究和解决的突出问题。本文通过对布病活疫苗生产检验、设施维修维护、生产人员个人防护等环节的生物安全风险点进行分析，对布病活疫苗生产线提出改进建议，为相关企业动物布病活疫苗生产提供参考。 |
| 关键词: 布鲁氏菌病活疫苗 兽药GMP 生物安全 风险分析 |
| DOI： |
| 投稿时间：2021-02-09修订日期：2021-04-26 |
| 基金项目:国家重点研发计划2016YFD0500903-牛羊重要疫病诊断与检测新技术研究 |
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| Prevention and Control of Biosafety Risk in the Production of Animal Brucellosis Live Vaccine |
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| (China Institute of Veterinary Drug Control) |
| Abstract: |
| Brucellosis live vaccine is an important biological resource for the prevention and control of brucellosis in the world. At present, the main production and application of brucellosis live vaccine are S2 strain and A19 strain in China. Biosafety is an important priority in the production of live brucellosis vaccine. With the implementation of veterinary drug GMP (2020 version), it is urgent to standardize the production and inspection of brucellosis live vaccine, and prevent and control the biosafety risk in the production process. In this paper, we analyzed the possible biosafety risk points in the production and inspection of brucellosis live vaccine, facility maintenance, production personnel protection and other links, in order to put forward reasonable and standardized suggestions for the process improvement of brucellosis live vaccine, and provide reference for the production of animal brucellosis vaccine. |
| Key words: Brucellosis live vaccine Veterinary drug GMP Biosafety Risk analysis |
