直接接触药品包装材料和容器标准管理模式思考

Deliberations for Management Model of Standards of Drug Immediate Packaging Materials and Containers

为了加强规范药包材标准备案管理要求。分析我国药包材质量标准管理要求和现状,探讨在标准编号、备案、公告和在药品注册应用中存在的不足。依据国家食品药品监督管理局13号令《直接接触药品的包装材料和容器管理办法》等法规文件,加强对药包材产品注册、生产、监管等方面的管理,提出推动按照中国药典管理药包材质量标准进程的建议。

To standardize and strengthen the administration of standard and registered product specifica- tion for pharmaceutical packaging. It was looked back on the course of registered product specifications for drug im- mediate packaging materials and containers briefly, discussed about practice difficulty of using registered product specifications in producing, supervision and applying for drug registration, analyzed the current status of numbering, issuing, checking using drug standardizing system for a reference. It was paid attention to administration for national standards and registered product specifications to ensure the quality of drug, and suggested that attribute them to Chinese Pharmacopoeia according to the legal status given by ＂Provisions for Drug Immediate Packaging Materials and Containers＂ （SFDA order Nb 13 ） and other related regulations.