Strengthening Quality System of National Pharmaceutical Control Laboratories of Thailand through participating in WHO Prequalification Programme

Abstract

       The WHO prequalification of quality control laboratories aims to increase access to quality control laboratories that meet recommended international standards for the analysis of medicinal products in the Prequalification Programme HIV/AIDS, Malaria and Tuberculosis products. These products were used principally by United Nations agencies to guide their procurement decisions. The assessment of quality control laboratories was performed according to WHO good practices for pharmaceutical quality control laboratories. In 2010, the Bureau of Drug and Narcotic, as national pharmaceutical control laboratory of Thailand, participated in the program in order to strengthen the quality system. During the first visit in 2011 for technical assistance, the WHO expert concluded that the Chemical and Physical Testing Section as well as the Reference Standards Centre were considered to be operating at a good level while the Biological Testing Section needed some improvements in laboratory premises prior to participating in the prequalification procedure. As recommended by the WHO expert, the inspection of both Chemical and Physical Testing Section and Reference Standard Center was conducted during 30 April – 2 May 2012. All non-compliances observed during the inspection included 2 major and 9 observations with no critical ones. It was concluded that the Bureau of Drug and Narcotic was considered to be operating at an acceptable level of compliance with WHO Good Practice for Pharmaceutical Quality Control Laboratories. After the corrective actions taken and planned were reviewed and approved, the Bureau of Drug and Narcotic was included in the WHO List of Prequalified Quality Control Laboratories and was the first national pharmaceutical control laboratory in WHO South-East Asia region in this list.