摘要
目的 为建设统一、规范、权威的国家药品检验报告书模板库提供参考。方法 根据药品检验报告书的内容及格式要求,紧扣药品检验与药品监管高质量发展需求,按国家药品检验报告书模板库的架构、功能、建设与共享对其进行初步规划。结果与结论 国家药品检验报告书模板库的架构可设计为用户界面层、计算机处理层、模板录入层、数据存储层、模板导出层,应包括权威发布、检验报告书格式执行功能,多方共建、检验项目模板库资源共享服务功能,国家药品标准数据库开放共享功能。按数据录入与审核、数据维护与动态更新、数据共享规划,国家药品检验报告书模板库应逐步打造为权威发布、数据集中、模板共享的实用平台,让药品检验高质量技术服务于药品监管发挥重要作用。
Objective To provide a reference for the construction of a unified,standardized,and authoritative template library of national drug inspection reports.Methods Based on the content and format requirements of the drug inspection reports,and the high-quality development needs of drug inspection and drug supervision,a preliminary plan was constructed according to the architecture,function,construction,and sharing of the template library of national drug inspection reports.Results and Conclusion The framework of the template library of national drug inspection reports can be designed as the user interface layer,computer processing layer,template entry layer,data storage layer and template export layer.It should include functions such as authoritative publication,execution of inspection report formats,multi-party co-construction,sharing of inspection project template library resources,and open sharing of national drug standard databases.According to data entry and review,data maintenance and dynamic up-date,and data sharing planning,the template library of national drug inspection reports should be gradually constructed into a practical platform for authoritative release,data concentration,and template sharing,and play an important role in drug supervision for high-quality technology of drug inspection.
作者
张芦燕
王庆
董文静
薛瑞
王坤
马融融
ZHANG Luyan;WANG Qing;DONG Wenjing;XUE Rui;WANG Kun;MA Rongrong(Ningxia Institute of Pharmaceutical Inspection,Yinchuan,Ningxia,China 750002)
出处
《中国药业》
2025年第7期4-7,共4页
China Pharmaceuticals
关键词
国家药品检验报告书模板
数据库
信息化平台
药品监管
template library of national drug inspection report
database
information platform
drug supervision
