USP DQI TRIP REPORT

The program is funded by the U.S. Agency for International Development (USAID) and aims to strengthen the quality assurance and quality control capabilities of Mozambique's medicines regulatory authority, the Departamento Farmacêutico (DF). In 2010, a rapid assessment of the DF's quality assurance and quality control capabilities was conducted, and PQM assisted the DF in establishing a medicines quality monitoring (MQM) program. Training in basic testing using Minilabs was provided in 2011, and in early 2012, PQM shipped laboratory equipment, supplies, and reagents necessary for a quality control laboratory to operate adequately. In April 2012, PQM installed the equipment and conducted training on how to use and properly operate it. Additionally, training was provided on how to effectively read and understand the USP-National Formulary (USP-NF) as well as compendia testing. Ms. Regina Okafor, Associate Program Manager, Africa, traveled to Maputo, Mozambique, from June 15 to 29, 2012, to conduct a series of activities. The purpose of the trip was to train all lab staff on Dissolution, Disintegration, and Karl Fischer testing, set up equipment and supplies shipped to the LNCQM after the April 2012 visit, follow up on progress of training given in April 2012, review MQM results from round 1, resolve any issues, and attend to any issues with round 2, and meet with USAID/Mozambique. The trip was funded by USAID/Mozambique through the President's Emergency Plan for AIDS Relief (PEPFAR). The activities conducted during the trip included training all lab staff on newly installed equipment, installing and qualifying equipment, furnishing the laboratory with appropriate equipment and supplies, clearing reagents, supplies, and materials shipped by PQM from customs, following up on MQM, and the official inauguration of the LNCQM by the Permanent Secretary. The training on Dissolution, Disintegration, and Karl Fischer testing was conducted to enhance the laboratory's capacity to test medicines for quality and safety. The equipment and supplies shipped by PQM were installed and qualified to ensure that the laboratory was equipped to perform the necessary tests. The laboratory was also furnished with printers for HPLC and UV, an AC unit for chemical storage, and a UPS for major equipment. The MQM results from round 1 were reviewed, and any issues were resolved. The progress of training given in April 2012 was followed up, and any issues with round 2 were attended to. The meeting with USAID/Mozambique discussed MQM activities, the workplan, and the status of the LNCQM's new permanent facility. The trip was successful, and PQM was able to complete the lab set-up, install all procured equipment, and demonstrate several laboratory tests for the LNCQM staff. The LNCQM temporary quality control laboratory was officially inaugurated by the Permanent Secretary.