Trip Report: LNCQM Temporary Quality Control Lab and Monograph Testing Training Workshop

The program's primary goal is to strengthen the quality control (QC) and quality assurance (QA) capabilities of Mozambique's medicines regulatory authority, the Departamento Farmacêutico (DF). PQM has been working with the DF to develop a training program to conduct basic tests on the quality of medicines and establish a medicines quality monitoring (MQM) program. In December 2010, PQM conducted a rapid assessment of the QA/QC capabilities of the DF, which identified inadequate infrastructure, equipment, and staff at the Laboratório Nacional da Qualidade de Medicamentos (LNCQM), the DF's QC laboratory. However, with proper training and resources, the LNCQM could become operational and begin conducting QC testing of medicines. A partnership was established between PQM and the DF to develop a training program to conduct basic tests on the quality of medicines and establish a MQM program. In October 2011, PQM trained stakeholders on basic testing of medicines using Minilabs and developed a comprehensive MQM protocol. The training program aimed to equip lab staff with the necessary skills to conduct basic tests using USP monograph compendia testing. The specific objectives of the training included good documentation practices, safety in the laboratory, weighing practices, and the importance of standard operating procedures (SOPs). A team from PQM, consisting of Dr. Abdelkrim Smine, Ms. Regina Okafor, and Mr. Matthew Morehouse, traveled to Maputo, Mozambique, to set up the temporary refurbished LNCQM quality control (QC) lab and train all lab staff on USP monograph compendia testing. The team also evaluated the progress of the MQM activities since the last comprehensive sampling and testing protocol training in October 2011. Additionally, the team met with USAID/Mozambique to discuss the building of the permanent LNCQM facility and provided technical suggestions and recommendations to fully furnish LNCQM. The trip was successful, and PQM was able to complete the lab set-up, install all available equipment, and demonstrate various tests. Consequently, LNCQM is able to weigh and prepare solutions as well as analyze samples utilizing several laboratory techniques. The team also provided technical assistance to LNCQM, including training on basic tests using USP monograph compendia testing, installing and qualifying equipment, and setting up the laboratory and equipment. The PQM program has been funded by USAID/Mozambique through the President's Emergency Plan for AIDS Relief (PEPFAR). The program's activities have focused on strengthening the quality control and quality assurance capabilities of Mozambique's medicines regulatory authority, the Departamento Farmacêutico (DF). The program has also established a partnership with the DF to develop a training program to conduct basic tests on the quality of medicines and establish a medicines quality monitoring (MQM) program. The PQM program has made significant progress in strengthening the quality control and quality assurance capabilities of Mozambique's medicines regulatory authority. The program has provided technical assistance to LNCQM, including training on basic tests using USP monograph compendia testing, installing and qualifying equipment, and setting up the laboratory and equipment. The program has also established a MQM program to monitor the quality of medicines in Mozambique.