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药品检验检测机构开展能力验证的质量控制要点 被引量:7

Key Points of Quality Control for Carrying out Ability Verification in Drug Inspection and Testing Institutions
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摘要 药品检验检测工作作为药品监管的重要技术支撑和手段,在准确判断药品质量和有效防范药品质量风险等方面具有十分重要的作用,同时也是保障药品安全的重要手段之一。全面提升药品检验检测实验室的技术水平,对保障药品安全具有重要意义。药品实验室的能力验证是利用实验室之间的对比来判定实验室能力的活动,也是检测机构加入和维持国际相互承认协议的必要条件之一。 As an important technical support and means of drug supervision,drug inspection and testing plays a very important role in accurately judging drug quality and effectively preventing drug quality risks.It is also one of the important means to ensure drug safety.It is of great significance to comprehensively enhance the ability of drug testing laboratories to ensure drug safety.Competency verification of pharmaceutical laboratories is an activity that uses the comparison between laboratories to judge the capacity of laboratories and is also one of the necessary conditions for accreditation bodies to join and maintain the international mutual recognition agreement.
作者 苑艳飞 刘广文 YUAN Yanfei;LIU Guangwen(Tai’an City Institute for Food and Drug Control and Testing,Tai’an,Shandong,271000,China)
出处 《质量安全与检验检测》 2021年第4期70-71,94,共3页 QUALITY SAFETY INSPECTION AND TESTING
关键词 药品检验 检测机构 能力验证 质量控制 Drug Testing Testing Institutions Ability Verification The Quality Control
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