浅谈药品微生物检测准确性的影响因素

Discussion on the Factors Affecting the Accuracy of Drug Microbial Detection

药品微生物检测项目是药品质量控制的重要组成部分,影响药品微生物检测结果准确性的因素有很多,人员、仪器设备、使用的试剂/培养基/菌种、检测方法、检测环境等,本文主要针对药品微生物的检验过程中,对影响检测准确性的相关因素展开讨论分析,建立科学合理的质量控制程序,避免由于检测误差而造成药品的不正确评价。

The drug microorganism detection project is an important part of the quality control of the drug,and the factors that affect the accuracy of the detection result of the drug microorganism are many,personnel,instrument and equipment,the reagent/culture medium/strain used,the detection method,the detection environment,etc.,In this paper,a scientific and reasonable quality control program is established to avoid the incorrect evaluation of the drugs due to the detection error.