关于药品抽查检验抽样量的思考  

Reflectionson the Sampling Quantity of Drug Inspection

作　　者：游万兴 陈蕾[2] 席永兵 

机构地区：[1]山西省食品药品检验所,太原030001 [2]国家食品药品监督管理局

出　　处：《中国药事》2012年第7期714-715,728,共3页Chinese Pharmaceutical Affairs

摘　　要：目的探索科学设定药品抽查检验抽样量的新方式。方法在满足检验、复核和留样的前提下,建议将抽样量由原来的"三倍全检量"降为"二倍全检量",并将所抽样品由原来的检验∶复核∶复验3份间的1∶1∶1的3等份签封,改为3∶2∶1的分配方式。结果与结论可降低1/3抽样量,既有助于化解与相对人的矛盾、缓解抽样难问题,又减少了资源浪费。Objective To explore new ways of scientific setting drug sampling quantity. Methods On the premise of meeting the inspection, review and retention samples, it is recommended that the sampling amount to be reduced from the original ＂ three times of the whole measurement＂ to ＂ two times of the whole measurement＂. Moreover, the sampling inspection implement which used to be three equal parts as test check ： retest= 1 ： 1 ： 1 is changed into the new distribution methods as 3 ： 2 ： 1. Results and Conclusion Reduction of one-third of the original sampling not only help to resolve the contradiction with the tested person, alleviate the difficulty of sampling, save energy, but also reduce pollutants discharge and the waste of resources.

关 键 词：药品 抽样量 抽查检验 复验 

分 类 号：R927.11[医药卫生—药学]