Evaluation of the Laboratory Quality Management System: Bureau of Drugs and Narcotics (BDN)

With financial support from the U.S. Agency for International Development (USAID), the U.S. Pharmacopeia (USP) has been providing technical assistance to Thailand since 2002. Activities have focused on three main areas to improve the quality of medicines, including strengthening the capacity of BDN by providing training on post-marketing surveillance, laboratory techniques, and ISO 17025 Quality Management System (QMS) awareness. BDN's goal is to broaden their current ISO 17025:2005 scope of accreditation and become prequalified by the World Health Organization (WHO) Prequalification Program. To achieve this goal, BDN needs to develop a plan for flexible scope expansion, which involves adding new methods to their accreditation scope. PQM suggested two methods (Sterility and Bioburden) for future scope expansion during their next surveillance or full reaccreditation assessment. During the visit, discussions were held with BDN staff regarding various aspects of QMS and other relevant topics, including flexible scope expansion, audit trails with older equipment, adding microbiological methods to the scope of accreditation, and sustainability and maintenance after accreditation. BDN staff asked several questions about documentation, microbiological methodology, measurement uncertainty, and equipment issues. PQM identified two ISO 17025 accredited organizations, TechMasters Electronics in Thailand and Davison Instruments in the U.S., as potential providers for combination pressure and temperature data loggers calibration support. The laboratory stated that they would like to expand their scope of accreditation to the microbiological area and expressed concerns about maintaining their current sample testing load and accepting new business. To address these concerns, PQM suggested that the laboratory will need to develop a sustainability and maintenance plan to maintain the amount of current equipment and potential sample loads being tested. When the laboratory adds more methods to their scope, they must delegate resources to handle new business and accreditation opportunities. BDN is ready to formally request scope expansion under ISO 17025:2005 with their accreditation body. Based on discussions, if the accreditation body does not allow further expansion by method without documenting the products tested, the laboratory may investigate a new accreditation body, possibly ACLASS in the U.S. Next steps include BDN deciding which methods will be updated for future flexible scope expansion before or during their full re-accreditation and preparing all documentation and equipment for flexible scope expansion to be submitted to the current accreditation body within the Physical Chemistry area. Suggested methods for future scope expansion include pH, KF, UV, LOD, and Disso.