| 裴云飞,张伟,王全柱,赵庆友,杨正宁.探讨食品药品检验机构生物安全一级和二级实验室风险管理[J].中国药事,2021,35(1):149-158 |
| 探讨食品药品检验机构生物安全一级和二级实验室风险管理 |
| On Risk Management of Biosafety Level I and Level II Laboratories in Food and Drug Inspection Institutions |
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| DOI：10.16153/j.1002-7777.2021.02.005 |
| 中文关键词: 生物安全 实验室 风险管理 |
| 英文关键词: biosafety laboratories risk management |
| 基金项目: |
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| 中文摘要: |
| 目的：为食品药品检验机构生物安全一级和二级实验室风险管理提供建设性意见。方法：简述我国生物安全实验室的分级，从主体及领导责任、实验室软硬件条件建设、生物样本管理、医疗废物处置及环境保护、违规处罚等方面汇总生物安全相关法律法规要求，分析生物安全实验室存在的风险和管理中存在的突出问题，提出解决建议。结果与结论：为进一步降低检验机构生物安全实验室的风险，实验室设立单位需进一步在健全生物安全组织管理架构、切实提升工作人员生物安全意识、完善生物安全管理制度、满足设施设备保障条件、严格自查与督查等管理方面，落实责任，脚踏实地地做好实验室生物安全管理工作，为检验工作提供有力支撑。 |
| 英文摘要: |
| Objective: To provide constructive suggestions for the risk management of biosafety level I and level II laboratories in food and drug inspection institutions. Methods: This paper briefly described the classification of biosafety laboratories in China, summarized the requirements of biosafety-related laws and regulations from the aspects of subject and leadership responsibilities, construction conditions of laboratory software and hardware, biological sample management, medical waste disposal and environmental protection, violation punishment, etc., analyzed the risks in biosafety laboratories and the outstanding problems in management and came up with some solutions. Results and Conclusion: In order to further reduce the risk of biosafety laboratories of inspection institutions, the establishment units of the laboratory need to further improve the biosafety organization and management structure, effectively enhance the staff's biosafety awareness, improve the biosafety management system, meet the standard of facility and equipment guarantee conditions, impose strict self-inspection and supervision and other management, implement the responsibility, put down-toearth laboratory biosafety management into place and provide strong support for inspection. |
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