三项国家药品监督管理局微生物能力验证结果分析  

Analysis of Results of Three NMPA′s Microbial Proficiency Testing Programs

作　　者：陆继伟 范一灵 陈祝康 谷广志 顾颂青 杨美成 高晓明 项新华[4] LU Jiwei;FAN Yiling;CHEN Zhukang;GU Guangzhi;GU Songqing;YANG Meicheng;GAO Xiaoming;XIANG Xinhua(NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiology,Shanghai Quality Inspection and Testing Center for Innovative Biological Products,Shanghai Institute for Food and Drug Control,Shanghai 201203,China;China State Institute of Pharmaceutical Industry,Shanghai 201203,China;Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]国家药品监督管理局药品微生物检测技术重点实验室,上海市创新生物制品质量检验检测中心,上海市食品药品检验研究院,上海201203 [2]中国医药工业研究总院,上海201203 [3]上海市食品药品包装材料测试所,上海201203 [4]中国食品药品检定研究院,北京100050

出　　处：《中国药学杂志》2025年第3期308-312,共5页Chinese Pharmaceutical Journal

摘　　要：目的通过对NIFDC-PT-288《药品中金黄色葡萄球菌检验能力验证计划》、NIFDC-PT-340《药品中需氧菌总数计数能力验证计划》和NIFDC-PT-446《药品中霉菌和酵母菌总数计数能力验证计划》能力结果的分析研究,评价全国范围内参加实验室的药品微生物检验水平,使监管机构掌握药品检验实验室的微生物能力状况,提高实验室能力水平。方法从结果满意率、发现问题和技术要点对结果进行了分析;从实验室类型、实验室数量、能力情况对实验室能力进行了分析。结果省级食品药品检验机构结果满意率为95.7%(NIFDC-PT-288)、86.4%(NIFDC-PT-340)和100.0%(NIFDC-PT-446);地市(县、区)级食品药品检验机构结果满意率为95.5%(NIFDC-PT-288)、83.9%(NIFDC-PT-340)和92.5%(NIFDC-PT-446),企业实验室结果满意率为86.7%(NIFDC-PT-288)、65.7%(NIFDC-PT-340)和80.2%(NIFDC-PT-446),其他类型实验室结果满意率为100.0%(NIFDC-PT-288)、61.5%(NIFDC-PT-340)和86.7%(NIFDC-PT-446)。结论三项微生物能力验证项目的成功开展,为实验室提供了有效的外部质量控制手段,也为监管机构掌握全国药品实验室微生物检测的能力状况提供了一手资料,药品检验实验室微生物定性检测能力较好,微生物的定量检测能力有待提高。OBJECTIVE To analyze the results of three NMPA′s Microbial Proficiency Testing Programs,NIFDC-PT-288,NIFDC-PT-340,and NIFDC-PT-446,to evaluate the microbiological testing abilities of laboratories nationwide in drug detection,thus the regulatory agencies can learn the microbiological proficiency status of drug inspection laboratories and the laboratories can improve the microbiological detection ability.METHODS The results of the three proficiency testing programs were analyzed regarding the satisfaction rate,identified problems,and key technical points,and the laboratory types,number of laboratories and capability of the laboratories participating the three proficiency testing projects were analyzed.RESULTS The result satisfaction rates of provincial food and drug inspection institutions were 95.7%(NIFDC-PT-288),86.4%(NIFDC-PT-340)and 100.0%(NIFDC-PT-446),while the satisfaction rates of municipal food and drug control institutions were 95.5%(NIFDC-PT-288),83.9%(NIFDC-PT-340)and 92.5%(NIFDC-PT-446),respectively.The satisfaction rates of enterprise laboratory were 86.7%(NIFDC-PT-288),65.7%(NIFDC-PT-340)and 80.2%(NIFDC-PT-446),respectively.The satisfaction rates of other types of laboratories were 100.0%(NIFDC-PT-288),61.5%(NIFDC-PT-340)and 86.7%(NIFDC-PT-446),respectively.CONCLUSION The successful implementation of the three microbiological proficiency testing programs has provided the laboratories with effective external quality control means,and it also provides the first-hand reference for regulatory authorities on the microbiological testing capability of nationwide drug laboratories.The qualitative microorganism testing ability of drug laboratories is basically good,while the quantitative microorganism testing ability needs to be improved.

关 键 词：微生物能力验证计划 金黄色葡萄球菌 需氧菌总数计数 霉菌和酵母菌总数计数 能力结果分析 

分 类 号：R917[医药卫生—药物分析学]