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引用本文:朱价,刘柱,阮昊,项新华.生物制品检验实验室能力建设现状剖析与优化策略研究[J].中国现代应用药学,2026,43(15):155-164.
Zhu Jia,LIU Zhu,RUAN Hao,XIANG Xinhua.A Study on Biological Products Testing Laboratories: Assessing Current Capability and Proposing Optimization Strategies[J].Chin J Mod Appl Pharm(中国现代应用药学),2026,43(15):155-164.
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生物制品检验实验室能力建设现状剖析与优化策略研究
朱价1, 刘柱1, 阮昊1, 项新华2
1.浙江省食品药品检验研究院;2.中国食品药品检定研究院
摘要:
目的 研究生物制品检验实验室的能力建设现状并提出对策建议,为该类实验室战略发展提供参考。方法 采用SWOT模型,探讨生物制品检验实验室目前所具有的优势和劣势,及面临的机遇和威胁。结果 通过SWOT模型分析,具备人员、仪器、区位、检验能力等优势的同时,也存在着创新不足、研究薄弱、信息技术欠缺的劣势。发展中既具有机遇,也面临着生物安全、客户需求、合作受限的威胁。结论 基于现状分析结果,适宜采取SO优势-机遇型战略,从人才、创新、生物安全、信息化、国际合作交流等维度提出优化策略。
关键词:  药品  生物制品  实验室  能力建设  SWOT
DOI:
分类号:R95
基金项目:
A Study on Biological Products Testing Laboratories: Assessing Current Capability and Proposing Optimization Strategies
Zhu Jia1, LIU Zhu, RUAN Hao, XIANG Xinhua2
1.Zhejiang Institute for Food and Drug Control;2.National Institutes for Food and Drug Control
Abstract:
ABSTRACT: OBJECTIVE In order to provide recommendations of strategic development for biological products testing laboratories, an assessment was made of the current capability, and the strategies were enhanced. METHODS The SWOT model was utilized as the research framework to analyze the strengths, weaknesses, opportunities, and threats encountered by biological products testing laboratories. RESULTS Through SWOT model analysis, while it possessed strengths in personnel, equipment, location, and testing capabilities, it also exhibited weaknesses such as insufficient innovation, inadequate research capacity, and a lack of information technology. In the course of development, it not only encountered opportunities but also faced threats including biosafety concerns, evolving customer demands, and limitations in collaboration. CONCLUSION In consideration of the findings from the analysis of the current circumstances, it is deemed suitable to adopt the SO strength-opportunity strategy. And strategies about talent, innovation, biosecurity, information, international cooperation and communication were put forward for its development.
Key words:  medicine  biological product  laboratories  capacity construction  SWOT
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