中国药学杂志2024,Vol.59Issue(5) :463-468.DOI:10.11669/cpj.2024.05.013

出口疫苗产品追溯标识系统研究

Research on the Traceability and Identification System for Exported Vaccine Products

刘睿智 林强 龙跃 王雪晶 姜宝刚 刘一漩
中国药学杂志2024,Vol.59Issue(5) :463-468.DOI:10.11669/cpj.2024.05.013

出口疫苗产品追溯标识系统研究

Research on the Traceability and Identification System for Exported Vaccine Products

刘睿智 1林强 1龙跃 2王雪晶 3姜宝刚 4刘一漩1
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作者信息

  • 1. 中国物品编码中心,北京 100011
  • 2. 中国合格评定国家认可中心,北京 100062
  • 3. 北京嘉华汇诚科技股份有限公司,北京 100085
  • 4. 中国生物技术股份有限公司,北京 100024
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摘要

目的 建立出口疫苗产品追溯标识系统设计方案,满足世界卫生组织(WHO)和一些西方国家对于疫苗追溯标识的技术要求.方法 通过对国内外疫苗追溯标识法律法规、标准、政策文件的研究,分析比较国内外追溯标识制度的异同.结果 建立了满足国内外要求的基于国际物品编码组织(GS1)标准体系的出口疫苗产品追溯编码、标识、载体、印制等技术方案.结论 我国出口疫苗产品追溯标识制度需要加强政策、标准的制定,并加以实施和推广.

Abstract

OBJECTIVE To establish a design scheme for the traceability and labeling system of exported vaccine products,in order to meet the technical requirements of the World Health Organization(WHO)and some Western countries for vaccine traceability and labeling.METHODS By studying the laws,regulations,standards,and policy documents on vaccine traceability labeling at home and abroad,the similarities and differences between domestic and foreign traceability labeling systems were analyzed and com-pared.RESULTS A technical solution for traceability coding,labeling,carrier,printing,and other aspects of exported vaccine products was established based on the GS1 standard system that meets domestic and international requirements.CONCLUSION It is necessary to strengthen the formulation of policies and standards for the traceability and labeling system for exported vaccine products in China,and implement and promote them.

关键词

国际物品编码组织/疫苗/追溯标识/追溯系统

Key words

GS1/vaccine/traceability labeling/traceability system

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基金项目

国家市场监督管理总局技术保障专项出口疫苗产品追溯标识系统研究与示范项目(2022YJ02)

出版年

2024
中国药学杂志
中国药学会

中国药学杂志

CSTPCD北大核心
影响因子:0.957
ISSN:1001-2494
参考文献量9
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