实施《医疗器械生产质量管理规范》加强对初包装材料的管理  

Strengthen Administration of Primary Packaging According to Good Manufacturing Practice for Medical Devices

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：《中国药事》2012年第2期112-115,共4页Chinese Pharmaceutical Affairs

摘　　要：目的保证医疗器械包装材料的质量能够满足医疗器械的要求。方法结合《直接接触药品的包装材料和容器管理办法》对药品包装材料产品注册、生产洁净度以及注册品种等管理要求展开讨论。结果与结论提出加强医疗器械初包装材料选择和生产管理方面的合理化建议。Objective To ensure the quality of packaging materials of medical devices can meet the requirements of medical devices.Methods It was researched about primary package materials of medical devices product on good manufacturing practice for medical devices,discussed about capability,sterilization compatibility,cleanliness and associated controlled environments,using the experience of registration regulations of pharmaceutical packaging materials and containers for a reference.Results and Conclusion It was suggested strengthening the administration of manufacturing for primary package materials of medical devices.

关 键 词：医疗器械 包装材料 管理 

分 类 号：TB489[一般工业技术—包装工程] R954[医药卫生—药学]