对当前药品标准复核检验的几点理解

Several viewpoints of the current verification process of drug specifications and quality control test

药品标准在药品质量监管和质量控制中均起到十分关键的作用。药品标准的产生、制定和认可过程中,复核检验作为一种重要的技术手段发挥着非常重要的支撑作用。当前,随着药品审评审批制度改革的不断深化,各项改革文件不断出台,部分法律法规的修订日益临近,业界对原来仅由法定药检机构承担的药品复核检验也越来越关注,希望有更深入的了解和认识。随着政府向社会购买服务范围不断扩大,除原有法定承检机构外,其他第三方检验机构、社会组织和企事业单位也可能开展与药品相关的检验。因此,本文从药品复核检验的内涵、应用范围、实施主体、内容、影响因素等方面进行介绍,以供从事药品复核检验人员参考。

Drug specifications have very critical functions in drug quality supervision and quality control.And as important technical means,the verification of drug specifications and following quality control test has a significant supporting role during the draft,formulation and approval of drug specifications.At present,along with the constant deepening innovation of drug review and approval system,new reform documents have been introduced continuously,and the revision of some current drug laws and regulations is extremely urgent,so the pharmaceutical industry pays close attention to the work for verification of drug specifications and subsequent quality control test,which is currently undertaken by the statutory drug test institutions.With the continuous extending of the scope for the government to purchase service from society,besides the statutory drug test institutions,other test companies as the third party,as well as social organizations,enterprises,or public institutions,may also carry out the work related to drug test in the future.The verification process for drug specifications and quality control test is explained in the following aspects in this article：connotation,scope of application,subject of implementation,content,and influence factors,to provide reference for personnel in this field.