Ethiopia Gains International Laboratory Accreditation

To better ensure the quality of medicines in Ethiopia, the country’s medicines quality control laboratory-the Product Quality Assessment Directorate (PQAD)-has attained the internationally recognized ISO/IEC 17025:2005 accreditation for testing and calibration laboratories. PQAD serves as the technical wing of the Ethiopian Food, Medicine and Health Care Administration and Control Authority (FMHACA), protecting the quality of food and medicines both before market authorization and while they are on the Ethiopian market.

PQAD’s partners that assisted the laboratory in achieving this accreditation include the U.S. Agency for International Development (USAID) and its Promoting the Quality of Medicines (PQM) Program in Ethiopia, which is implemented by the U.S. Pharmacopeial Convention (USP) with funding provided by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). PQM works with regulatory authorities in developing countries around the world to safeguard the quality of medicine, principally those treating malaria, HIV/AIDS and tuberculosis.

ACLASS, an internationally recognized accrediting body based in Washington, D.C., awarded PQAD the ISO/IEC accreditation for seven key analytical tests. This accreditation certifies that PQAD is providing valid and trustworthy data to the Ethiopian Ministry of Health. PQAD is the first medicine quality control laboratory under a Ministry of Health in Sub-Saharan Africa to obtain this accreditation by a U.S. based internationally recognized accrediting body. While PQM has assisted laboratories in Southeast Asia and South America qualify for similar accreditation, this is the first PQM-assisted laboratory in Sub-Saharan Africa to achieve accreditation.

“The ISO/IEC 17025:2005 accreditation positions PQAD among Africa’s elite laboratories in the area of pharmaceutical quality control,” said Mr. Denekew Yehuleu Alamneh, director-general of FMHACA. “With this achievement, we have demonstrated our ability to produce reliable results that will give authorities-within Ethiopia and internationally-confidence in decisions impacting the health of patients.”

“Much of the laboratory work essential to medicines quality testing entails complex methods and procedures that must be followed meticulously to ensure accurate results. The importance of this accuracy cannot be understated,” said Patrick Lukulay, Ph.D., director of the PQM Program. “With this accreditation, PQAD demonstrates that its technical operations and administrative systems are functioning at the highest quality levels by international standards, producing accurate, valid results that can be trusted by the international community.”

“Obtaining this world-class accreditation is a laborious process that demonstrates a strong commitment to excellence at every level of the laboratory,” said Ms. Sheri-Nouane Duncan-Jones, deputy health office chief USAID Ethiopia. “PQAD’s dedication to continuous improvement will put the laboratory in a position to contribute to improving access to good quality medicines in Ethiopia and the entire region.”

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