ABSTRACT
OBJECTIVE:To strengthen quality management of drug microbiology laboratory and provide reference for relevant inspection institutions. METHODS:Taking measures from the laboratory document management,personnel training,quality con-trol,quality supervision,process control and biological safety,the elements of laboratory quality management were analyzed,and effectively measures were put forward to improve the management level. RESULTS & CONCLUSIONS:The laboratory should es-tablish strict,standardized,systematic laboratory management rules and regulations,quality documents,operating procedures, work guide,etc. to achieve documented management;develop various forms of annual training and assessment programs to con-struct a professional team;strengthen internal(developing an annual internal quality monitoring plan,conducting quality control ac-tivities,regularly checking the suitability of the medium) and external (capability testing,inter-laboratory comparison) manage-ment control level,and reasonably formulate the contents and frequency by combing with actual situation. Besides,the laboratory should strengthen inspection process control,attach great importance to the biological safety management to reduce the risk of labo-ratory quality to a minimum.