The Ethiopian national quality control laboratory has gained ISO accreditation to improve access to safe medicines.
Achieving accreditation equips the Ethiopian Product Quality Assessment Directorate (PQAD) to ensure drugs standards. The Promoting the Quality of Medicines (PQM) Program supported the effort.
Patrick Lukulay, director of the PQM Program, said: “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.”
The PQM Program is backed by the US Agency for International Development (USAID) and run by the US Pharmacopeial Convention (USP). PQM has worked with laboratories in Southeast Asia and South America on accreditation, but Ethiopia is its first project in sub-Saharan Africa to reach this level.
PQAD gained ISO/IEC 17025:2005 accreditation, which covers testing and calibration, for “seven key analytical tests”. Having the certification could help the Ethiopian Food, Medicine and Health Care Administration and Control Authority (FMHACA) internationally.
“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”, Denekew Yehuleu Alamneh, director-general of FMHACA, said.
Efforts to raise standards will continue. “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”, Sheri-Nouane Duncan-Jones, deputy health office chief USAID Ethiopia, said.
Efforts are underway to boost production in nations neighbouring Ethiopia. In April the East African Community (EAC), comprised of Kenya, Uganda, Tanzania, Rwanda and Burundi, approved a draft regional manufacturing plan and it is expected to boost local production capacity.
Standardisation of regional policies will allow companies to sell drugs across the five member states, The East African reports , and businesses, such as Biodeal, plan to expand to meet rising demand.