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| 疫苗生产与GMP认证检查的生物安全问题探讨 | |
| 引用本文： | 马东光,张爱萍,马霄,李凤祥. 疫苗生产与GMP认证检查的生物安全问题探讨[J]. 中国药事, 2011, 25(12): 1171-1173 |
| 作者姓名： | 马东光 张爱萍 马霄 李凤祥 |
| 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. 中国食品药品检定研究院 |
| 摘 要： | 目的提高生物制品企业及GMP检查人员对生物安全的认识,加强对GMP生物安全相关条款的理解。方法通过具体的事例对GMP检查过程中生物安全的重要性进行论述,并对危险性进行了评估。结果与结论希望中国的生物制品生产企业在生物安全防护方面有切实的提高,更希望检查员队伍得到全面正确的培训和指导,真正使GMP落到实处。 |
| 关 键 词： | GMP检查 生物安全 |
Discussion on Bio-safety for Vaccine Production and GMP Certification Inspection |
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| Ma Dongguang,Zhang Aiping,Ma Xiao,Li Fengxiang. Discussion on Bio-safety for Vaccine Production and GMP Certification Inspection[J]. Chinese Pharmaceutical Affairs, 2011, 25(12): 1171-1173 | |
| Authors: | Ma Dongguang Zhang Aiping Ma Xiao Li Fengxiang |
| Affiliation: | Ma Dongguang,Zhang Aiping,Ma Xiao1 and Li Fengxiang1(State Food and Drug Administration Certification Center,Beijing 100061,1National Institutes for Food and Drug Control) |
| Abstract: | Objective To enhance the bio-safety ideas in GMP inspectors and operators working in biological manufactures,to strengthen the understanding of GMP items for bio-safety.Methods Through specific examples of the GMP inspection process,the importance of bio-safety were discussed and the risk was assessed.Results and Conclusion To help the biological manufactures improvement in bio-safety,give some instructions to GMP inspectors,and also hope the ideas for bio-safety can be truly put into practice. |
| Keywords: | GMP inspection bio-safety |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |