科学合理核算检验用量 建设系统规范的信息平台

Science Reasonable Check the Amount of Samples and Constructing Systemic and Criterial Information Platform

药品检验在药品质量监管、药品注册审批等行政管理中发挥着不可替代的技术支撑作用。检验用量的确定由于没有规范统一的指导文件,在实际操作中难以准确掌握,因而各地抽送样品数量相差甚远。不仅造成药品资源浪费,也加重了相关部门工作成本。探讨科学合理核算检验用量的方法,建设系统规范的检验信息查询平台,是相关部门及工作者关注的问题。结合管理文件中关于检验用量的规定,通过对近年来药检所各类检验样品数量的汇总研究,分析了目前样品抽送样量存在的问题,提出了药品检验项目和用量查询信息平台建设的几点建议。

Drug test is very important to quality supervision, registration and approvement. There is no guidance to confirm the samples amount for test. Therefore, the amount of samples from all over the country is quite different, which bring on resource waste and increase the cost in sample management of supervise and test department. It is very significant that installing scientific and rational medium of sample amount and examination item, setting up systematic and normative query platform. This paper summarizes and investigates the sample number for inspection in recent years, analyzed the existent problem of sample amount currently, and put forward several suggestion for constitute the search information of the drug testing item and sample amount.