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National Laboratory for Medicine Quality Testing Inaugurated in Mozambique

In an important step towards further protecting its national supply of good quality medicines, the nation of Mozambique recently has established the Laboratório Nacional de Controle de Qualidade dos Medicamentos (LNCQM), which is responsible for testing the quality of pharmaceutical products and plays an important role in the battle against the proliferation of substandard and counterfeit medicines in the region.

The national laboratory is the quality control arm of the Departamento Farmacêutico (Pharmaceutical Department) of Mozambique's Ministry of Health. The temporary location in Maputo that has been used to house the LNCQM since 2011 was inaugurated last month as its official site.

The former national laboratory for medicine quality control in Mozambique was shut down in 2008. Since that time, the United States Agency for International Development (USAID) and the Promoting the Quality of Medicines (PQM) program have been actively involved in helping to assess and develop the quality assurance and quality control (QA/QC) capacities of the country.

A cooperative program between USAID and the U.S. Pharmacopeial Convention (USP), PQM helps to ensure the quality and safety of medicines globally by providing technical assistance to developing countries. PQM works to increase the capacities of national control laboratories of regulatory bodies in countries primarily in sub-Saharan Africa, Southeast Asia, Latin America, and the Caribbean, as well as Russia.

According to Dr. Patrick Lukulay, vice president of global health impact programs and PQM director at USP, “The combined efforts of the government, USAID and PQM have revitalized the nation's capability to protect the quality of its medicines, which is critical for maintaining and improving the health of Mozambique's citizens.”

“By establishing a central body to monitor and confirm the quality of medicines based on testing conducted by local trained personnel, the nation of Mozambique has strengthened its ability to protect public health—not only within its own borders—but in the region overall,” said Ms. Polly Dunford, acting director of USAID-Mozambique.

USAID and PQM's efforts in Mozambique began in 2008 with an assessment of the nation's capacity for monitoring and testing medicines. The evaluation was followed by a study in 2011 to determine medicine quality in two prominent provinces—Maputo and Gaza. This ultimately led to a recommendation by USAID and PQM that technical equipment and training of personnel would be key for re-establishing the country's medicine quality monitoring and control capabilities. A Medicine Quality Monitoring (MQM) program was set up in the provinces of Maputo, Zambezia, Nampula and Sofala, and PQM has held on-site training for LNCQM staff as well as laboratory personnel from all four provinces.

Also in 2011, a facility was established to temporarily house the LNCQM. With the help of USAID and USP, the LNCQM was furnished with the laboratory equipment needed to conduct further confirmatory tests on medicines found to be of substandard quality. USP provided the laboratory with copies of two of its compendia of public medicine quality standards—U.S. Pharmacopeia and National Formulary (USP-NF)—along with chemical reference materials for quality testing. PQM continues to train personnel as well as conduct follow-up MQM activities within Mozambique.

This September, the LNCQM will host the 2nd Annual Network of African Medicines Quality Control Laboratories (NAMCOL) with Dr. Maria Isabel Chemane, LNCQM's director, presenting on Mozambique's medicine quality control activities. Formed to promote communication and exchange of information among participating countries, NAMCOL is dedicated to strengthening the performance and technical skill of quality control laboratories' personnel and harmonizing methods for medicine approval across countries in the region to help address the threat of substandard and counterfeit drugs.
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