药品无菌检查OOS结果的调查与分析  

On the OOS Results of Drug Sterile Examination

作　　者：朱晓燕[1] 陈伟盛[1] 关倩明[1] Zhu Xiaoyan Chen Weisheng Guan Qianming(Guangzhou Institute for Drug Control, Guangzhou 510160, China)

机构地区：[1]广州市药品检验所,广州510160

出　　处：《中国药事》2017年第7期750-753,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:对药品无菌检查实验进行回顾性调查分析,探索药品无菌检查阳性结果调查的规范操作规程。方法:参照新版GMP中的超限度(OOS)调查章节,逐条分析可能引入微生物污染的相关因素,并针对性地分析现场环境引入污染的可能性。结果:初步建立了药品无菌检查阳性结果调查的分析方案。调查结果表明,检出菌并非实验室检验过程带来的污染,而是来自样品本身。结论:微生物实验室建立完善的OOS调查方案用于规范调查操作过程,对微生物实验室的质量管理具有重要的指导意义。Objective： To explore the standard operating procedure for the survey of the positive results of drug sterile examination using retrospective investigation and analysis of the sterile examination test. Methods： The factors related to microbial contamination were analyzed one by one; the possibility of the contamination introduced by the field ambient was also analyzed on purpose according to out of specification（OOS） survey chapter in the new version of GMP. Results： A preliminary program for analysis of positive results of drug sterile examination was established and the fact that the detected bacteria was not due to the contamination of the examination test, but the sample itself was found out. Conclusion： The establishment of a perfect OOS survey program to standardize the survey process has a great guiding significance to the management of microbiology laboratory.

关 键 词：药品检验 无菌检查 微生物污染 超限度(OOS) 实验室污染排除 实验室质量管理 

分 类 号：R927.1[医药卫生—药学] R95