新修订药品GSP及检查指导原则中的问题探讨  

Analysis of Problems in New Revised Medicine GSP and Inspection Guiding Principle

作　　者：冉大强[1] 王芳[1] 林晓明[1] 

机构地区：[1]山东省食品药品监督管理局审评认证中心,济南250013

出　　处：《中国药事》2015年第10期1032-1035,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:加强对药品批发企业的有效监管,确保消费者的用药安全。方法:分析实施新版《药品经营质量管理规范》和《药品经营质量管理规范现场检查指导原则》过程中,药品监管部门及药品批发企业反映较集中的问题,提出相应建议。结果与结论:《药品经营质量管理规范现场检查指导原则》应放宽对直调的限制,弱化首营品种概念,统一对冷藏冷冻药品的标注方式,对缺陷问题的判定应更加科学、规范。Objective： To strengthen the supervision of the medicine wholesale enterprises so as to ensure drug safety for consumers. Methods：The major problems relfected by the executives of medicine administrations and medicine wholesale enterprises were analyzed in the implementation of the new revised medicine GSP and the GSP on-site inspection guiding principle, and then the corresponding suggestions were put forward.Results and Conclusion：In the GSP on-site inspection guiding principle, restrictions on direct delivery of medicines should be loosened, the concept of ifrst purchasing medicinces should be weakened, labeling of refrigerated medicines should be standardized, and determination of defects should be more scientiifc and normative.

关 键 词：新修订GSP 存在问题 解决建议 

分 类 号：R954.2[医药卫生—药学]