摘要
目的介绍国际标准化组织(ISO)药包材标准体系与内容,为我国药包材标准体系的构建提供参考,以促进我国药包材行业发展。方法收集整理ISO/TC76最新资料及其制定的药包材相关标准,对ISO/TC76药包材标准体系架构和主要内容进行分析,介绍其制修订标准的最新进展。结果ISO药包材标准体系架构较为完整和清晰,标准内容既重视科学严谨性也具有一定的灵活性。结论ISO标准体系庞大,ISO/TC76药包材标准体系中大部分标准为产品标准;而《中华人民共和国药典》是独立的标准体系结构,其药包材标准除了常规技术指标外,还需关注产品检测方法、检验规则、命名原则等方面。ISO药包材标准体系对我国药包材标准体系的构建有一定借鉴作用,应注重ISO标准的科学性及影响力,同时结合我国国情辨证对待ISO标准。
Objective To introduce the standard system and content of International Organization for Standardization(ISO)for pharmaceutical packaging materials,to provide reference for building China's standard system for pharmaceutical packaging materials,and to promote the development of China's pharmaceutical packaging industry.Methods The latest data and standards related to pharmaceutical packaging materials formulated by ISO/TC76 were collected and sorted.The structure and main content of ISO/TC76's standard system for pharmaceutical packaging materials were analyzed.And the latest progress in developing and revising standards was introduced.Results The ISO standard system for pharmaceutical packaging materials had a complete and clear structure,and the content of the standards was good both in scientific rigor and flexibility.Conclusion The ISO standard system is comprehensive,and most of the standards in ISO/TC76's standard system for pharmaceutical packaging materials are product standards.The Chinese Pharmacopoeia is an independent standard system structure.And its pharmaceutical packaging materials standards include not only conventional technical specifications,but also product testing methods,inspection rules,naming principles and other aspects.The ISO standard system for pharmaceutical packaging materials can provide some guidance for building China's standard system.We should pay attention to the scientificity and influence of ISO standards,while also dialectically understand ISO standards combining actual situations in China.
作者
于晓慧
施燕平
高用华
许凯
陈蕾
YU Xiaohui;SHI Yanping;GAO Yonghua;XU Kai;CHEN Lei(Shandong Institute of Medical Devices and Pharmaceutical Packaging Inspection,NMPA Key Laboratory of Quality Control for Pharmaceutical Packaging,Jinan 250101,China;China National Pharmaceutical Packaging Association,Beijing 100803,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)
出处
《医药导报》
CAS
北大核心
2023年第7期1020-1025,共6页
Herald of Medicine
关键词
药包材
标准体系
ISO/TC76
Pharmaceutical packaging materials
Standard system
ISO/TC76
