企业情况说明在药品抽验评价中的地位与作用  

The Role and Function of Drug Manufacturer's Representation Letter in Drug Sampling and Testing

作　　者：倪明[1] 魏立平[1] 冯磊[2] 周尚[1] 

机构地区：[1]中国人民解放军总后勤部卫生部药品仪器检验所,北京100071 [2]中国食品药品检定研究院

出　　处：《中国药事》2013年第5期460-462,共3页Chinese Pharmaceutical Affairs

摘　　要：目的促进制药企业分析查找产品不符合标准规定的原因,确保制药行业的健康发展。方法对企业情况说明在药品评价抽验中的作用进行了系统分析。结果与结论企业情况说明对企业和政府均意义重大,需要引起双方的共同重视。Objective To impel the drug manufacturer＇s to search and analyze and find out the cause of failure to meet standards and ensure the healthy development of pharmaceutical industry. Methods A systematic analysis was performed on the role of representation letter of drug manufacturer＇s in drug sampling and testing. Results and Conclusion The representation letter of drug manufacturer＇s has great significance for both drug manufacturer＇s and governments to which both parties should pay special attention.

关 键 词：药品抽样 药品检验 企业情况说明 

分 类 号：R954.2[医药卫生—药学]