药品微生物检测实验室质量管理的要点分析

Analysis of key points of quality management in drug microbiological testing laboratory

药品微生物检测实验室是药品生产企业质量控制的核心内容之一,其质量管理存在较大特殊性,因此从人员、设备、检测相关物料、检测方法、设施环境、检测数据方面对药品微生物检测实验室质量管理的要点、典型性缺陷举例分析,为药品生产企业、药品检测机构提供参考借鉴。

Drug microbiological testing laboratory is one of the core contents of quality control in drug manufacturing enterprises,and its quality management has significant specificity.This article analyzes the key points and typical deficiencies cases of quality management in drug microbiological testing laboratories from the aspects of personnel,equipment,testing related materials,testing methods,facility and environment,and testing data,providing reference for pharmaceutical production enterprises and testing institutions.