USP Improves Access to Quality Condoms in Africa by Helping the Ethiopian Food, Medicine, & Health Care Administration & Control Authority Achieve ISO Accreditation

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“Accreditation of quality control laboratories is a key component in ensuring the quality of condoms used in HIV/AIDS control programs, a critical prevention element in a comprehensive, effective and sustainable approach to HIV” – Patrick Lukulay, Ph. D., USP

Condom testing in Ethiopia

Condom testing in Ethiopia

Confidence in both medicines and medical devices is a key component of public health regardless of where you live.

The US Pharmacopeial Convention (USP) is pleased to report that the Product Quality Assessment Directorate (PQAD) of The Ethiopian Food, Medicine, & Health Care Administration and Control Authority (FMHACA) was successfully reassessed by the ANSI-ASQ National Accreditation Board for ISO/IEC 17025:2005 accreditation and through scope expansion also found to be compliant with ISO 4074:2014 for technical competence in its laboratories for testing male condoms. This important third party recognition for competence in quality testing was achieved with the support of the Promoting the Quality of Medicines (PQM) program – a USAID funded program implemented by USP. Specifically, the laboratory is now the first official medicines control laboratory in Central Africa to receive accreditation for conducting quality control testing on male condoms.

The reassessment and expanded accreditation is an important step in the ongoing fight against HIV/AIDS in Africa. In recent years, efforts to fight HIV/AIDS has been seriously challenged by reports of condom manufacturers dumping substandard products on the African market, including supplies sold to public health programs. Not only did the presence of poor quality condoms pose risks in terms of the transmission of infections and/or failure to prevent pregnancy, reports of their existence threatened to erode public confidence in public health distribution programs.

“Confidence in both medicines and medical devices is a key component of public health regardless of where you live,” said Patrick Lukulay, Ph.D., Vice President of USP’s Global Health Impact Programs and director of the PQM program. “But it is especially important to programs where public health professionals are trying to encourage the adoption of critical preventive behaviors such as condom use. Not only will ISO 4074:2014 for the PQAD lab increase the supply of quality assured condoms and improve public confidence, by building local capacity for quality assurance, the accreditation increases program sustainability by reducing reliance on donor subsidies and increasing country ownership and independence.”

Through the USAID funded “Promoting the Quality of Medicines” (PQM) program, USP works with medicines regulatory authorities, manufacturers, quality control professions and others to improve public health by building local capacity to ensure good quality medicines. The accreditation for FMHACA is the first time PQM has helped a laboratory achieve international accreditation for quality control testing of a medical device.

Under the current ISO/IEC 17025:2005 accreditation, the ISO 4074: 2014 based scope expansion means the Ethiopian Food, Medicine, & Health Care Administration and Control Authority has the expertise to ensure the condoms they procure for public distribution programs meet international standards and pass a wide range of quality control tests for specific quality attributes including: freedom from holes; adequate inflation volume and pressure; lubricant quantity; dimension appropriate to the target population; as well as package seal integrity.

Since 2009, PQM has worked in collaboration with national counterparts to support country ownership and sustainability through quality assurance systems improvements and the introduction of new technologies to support medicines quality monitoring in low-resource settings in over 35 countries across 4 continents.


The Promoting the Quality of Medicines (PQM) program is made possible by the generosity of the American people through the United States Agency for International Development (USAID).

USP – Global Expertise, Trusted Standards, Improved Health
The U.S. Pharmacopeial Convention (USP) is a global health organization that improves lives through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP’s standards are used worldwide. For more information about USP, visit

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