建设满足数据完整性要求的药品微生物检测实验室路径探析  

Construction of Pharmaceutical Microbial Testing Laboratory with Alignment of Data Integrity Requirements

作　　者：滕贇 刘雅丹[2] 崔黎 韩峰 王恺 常艳[2] Teng Yun;Liu Yadan;Cui Li;Han Feng;Wang Kai;Chang Yan(Inner Mongolia Institute for Drug Control,Huhhot 010041,China;National Institutes for Food and Drug Control,Beijing 102629,China;Nantong Food and Drug Supervision and Testing Center,Nantong 226413,China)

机构地区：[1]内蒙古自治区药品检验研究院,呼和浩特010041 [2]中国食品药品检定研究院,北京102629 [3]南通市食品药品监督检验中心,南通226413

出　　处：《中国药事》2024年第6期617-626,共10页Chinese Pharmaceutical Affairs

基　　金：南通市科技项目地产特色中药品种晕可平颗粒微生物安全保障体系的建立(编号MS22022027)。

摘　　要：目的:分析现有药品领域微生物检测实验室管理模式中存在的问题,有针对性地提出满足数据完整性要求的药品微生物检测实验室的运行方式。方法:梳理法律法规、检测标准、行业规范及实验室认可规则、认可准则及相关应用说明中涉及微生物实验室的基本管理要求;归纳总结当前国内微生物检测实验室中实际存在的多发性问题;尝试分析现有运行模式中可能存在的管理弊端。结果与结论:在满足法律法规、行业标准及认可基本要求的前提下,探讨了使用智慧化方式建设满足数据完整性要求的药品微生物检测实验室的方式,为行业实验室建设提出合理化建议。Objective:To analyze the problems existing in the management mode of pharmaceutical microbial testing laboratories,and put forward the operation mode of pharmaceutical microbial testing laboratories to meet the requirements of data integrity.Methods:The basic management requirements of microbial laboratories in laws and regulations,testing standards,industry norms and laboratory accreditation rules,accreditation standards and related application instructions were sorted out.The multiple problems in microbial testing laboratories in China were summarized.The possible management disadvantages in the existing operation mode were tried to analyze.Results and Conclusion:Under the premise of meeting the basic requirements of laws and regulations,industry standards and accreditation,this article discusses the use of intelligent way to construct pharmaceutical microbial testing laboratories that meets data integrity requirements,and puts forward reasonable suggestions for the construction of industrial laboratory.

关 键 词：药品微生物检测 数据完整性 智慧化管理 实验室认可 

分 类 号：R95[医药卫生—药学]