药品生产洁净环境检测能力验证活动的开发与实施  

Development and Implementation of Proficiency Testing of Clean Environment Detection for Pharmaceutical

作　　者：田霖[1] 赵燕君 仪忠勋 吴慧 谢兰桂[1] 赵霞[1] 杨会英[1] Tian Lin;Zhao Yanjun;Yi Zhongxun;Wu Hui;Xie Langui;Zhao Xia;Yang Huiying(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院国家药品监督管理局药用辅料质量研究与评价重点实验室,北京100050

出　　处：《中国药事》2025年第2期191-197,共7页Chinese Pharmaceutical Affairs

基　　金：中国食品药品检定研究院学科带头人培养基金课题(编号2023X9)。

摘　　要：目的:推进国内洁净环境尤其是药品生产洁净环境检测水平的提升,发挥外部质量评价对检验机构能力建设与维护的正向引导作用。方法:中国食品药品检定研究院(简称中检院)于2022年首次设计并组织实施了洁净环境能力验证项目。采用现场测试与笔试考核相结合的方式对不同实验室照度、风速、悬浮粒子3个项目的检测能力进行考察。结果:全国30家检验检测单位的53人参加了首次洁净环境能力验证活动,从照度、风速、悬浮粒子项目的考核反映出部分实验室对于标准的理解与掌握、仪器校准等方面的问题。结论:洁净环境能力验证活动较为全面客观地考察了参加实验室的能力情况,成为洁净环境领域检测实验室强有力的外部质量评价手段,有助于保障药品生产的洁净环境参数符合要求,进而保证药品的质量与安全。不同洁净环境能力验证项目的实施为中检院洁净环境全参数能力验证的覆盖打下基础。Objective:To promote the improvement of inspection level of the domestic clean environment,especially in the clean environment for pharmaceutical production,and give play to the positive guiding role of external quality evaluation on the capacity building and maintenance within inspection institutions.Methods:The National Institutes for Food and Drug Control(NIFDC)designed and implemented the proficiency testing of clean environment detection for the first time in 2022.The detection ability of luminance,wind speed and suspended particles in different laboratories was investigated by combining field test and written test.Results:Total of 53 people from 30 inspection and testing units across the country participated in this proficiency testing.The test revealed issues in some laboratories in understanding and mastering standards and instrument calibration.Conclusion:The proficiency testing of clean environment detection comprehensively and objectively investigate the abilities of participating laboratories,and become a powerful external quality evaluation means for testing laboratories in the field of clean environment.It is helpful to ensure that the clean environment parameters of drug prcduction meet the requirements and ensure the quality and safety of drugs.The implementation of different clean environment capability verification projects lays a foundation for the coverage of clean environment full parameter proficiency testing of NIFDC.

关 键 词：洁净环境 能力验证 悬浮粒子 照度 风速 

分 类 号：R95[医药卫生—药学]