Development of the Laboratory Quality Management System: Bureau of Drug and Narcotic

Abstract

       The Bureau of Drug and Narcotic, Department of Medical Sciences is the reference laboratory for the drugs and narcotics. The main responsibility is to analyze the pharmaceutical and narcotic samples. Quality management system of the Bureau was assessed by the Bureau of Laboratory Quality Standards, Department of Medical Sciences on 27-28 October 2014, and 6-7 November 2014 according to ISO/IEC 17025:2005. The findings showed that there were 14 conditions and 14 observations needed to be improved. In addition, the Bureau was also assessed according to WHO good practices for pharmaceutical quality control laboratories by WHO inspectors on 3-4 November 2014. No critical errors were found, however 7 other observations and 1 major observation were reported. These quality control activities make the Bureau being continuously improved and accredited.