关于直接接触药品的包装材料和容器标准化管理的探讨和改进  

Suggestions on Administration of Standardization for Drug Immediate Packaging Materials and Containers

作　　者：李宝林 

机构地区：[1]河北省医疗器械与药品包装材料检验所,石家庄050061

出　　处：《中国药品标准》2012年第2期129-132,共4页Drug Standards of China

摘　　要：简要回顾我国药包材管理的发展历程,分析药包材标准的管理现状和执行过程中出现的不足。依据国家局13号令《直接接触药品的包装材料和容器管理办法》对药包材标准的名称、标准编号、企业标准以及注册管理中有待进一步规范之处进行了初略讨论,提出合理的改进建议,以强化药包材的管理,为药品质量提供有力的保障。It was looked back on the course of registration for drug immediate packaging materials and containers, analyzed of the current status of validating, naming, numbering in national standards drug immediate packaging Materials and Containers and relative product specifications, discussed about practice which do not meet ＂Provisions for Drug Immediate Packaging Materials and Containers ＂ （ the order No. 13 of SFDA）. It was suggested further strengthening supervision and standardization of drug immediate packaging materials to ensure the quality of drug.

关 键 词：药品包装材料 标准化 注册管理 

分 类 号：R197.32[医药卫生—卫生事业管理]