UNITED STATES PHARMACOPEIA
The Promoting the Quality of Medicines (PQM) program is a program implemented by the United States Pharmacopeia (USP} in collaboration with the United States Agency for International Development (USAID}.
2011 · 40 pages

Abstract
The program aims to address the growing challenge posed by the proliferation of substandard and counterfeit medicines (SCMs}. PQM serves as a primary mechanism to help ensure the quality, safety, and efficacy of medicines essential to USAID priority diseases, particularly malaria, HIV/AIDS, and tuberculosis. The program is a response to the growing threat of SCMs, which are recognized as a serious public health threat, especially in low- and middle-income countries. The PQM program is based on a system-based, five-pronged strategy that enables countries to address the problem of SCMs in a comprehensive, systematic, and systematic manner. The strategy includes promoting the supply of good-quality medicines, targeting substandard and counterfeit medicines, raising public awareness about the negative health consequences of using medicines other than those whose quality has been assured, and strengthening national quality assurance systems. PQM continues many of the successful activities begun during the Drug Quality and Information (DQI) program. The program has provided technical assistance to 20 countries to strengthen national capacity in quality assurance and quality control systems. One approach PQM has employed is helping national quality control laboratories operate with good laboratory practices and become accredited in ISO/IEC 17025:2005, a recognized standard of proficiency. The program has also conducted numerous workshops to inform manufacturers of second-line tuberculosis drugs how to produce quality-assured medicines by following good manufacturing practices and worked with individual companies to secure WHO Prequalification status. PQM advocates globally, nationally, and locally for the importance of quality assurance of medicines to the effectiveness of treatment regimens. In FY11, PQM implemented a range of activities to support USAID priority health objectives in four regions: Sub-Saharan Africa, South East Asia, Europe/Eurasia, and Latin America and the Caribbean. The program provided technical assistance to 20 countries to strengthen national capacity in quality assurance and quality control systems. In Sub-Saharan Africa, PQM implemented a range of activities to support USAID priority health objectives, including the provision of technical assistance to national quality control laboratories to operate with good laboratory practices and become accredited in ISO/IEC 17025:2005. The program also conducted workshops to inform manufacturers of second-line tuberculosis drugs how to produce quality-assured medicines by following good manufacturing practices. In South East Asia, PQM implemented a range of activities to support USAID priority health objectives, including the provision of technical assistance to national quality control laboratories to operate with good laboratory practices and become accredited in ISO/IEC 17025:2005. The program also conducted workshops to inform manufacturers of second-line tuberculosis drugs how to produce quality-assured medicines by following good manufacturing practices. In Latin America and the Caribbean, PQM implemented a range of activities to support USAID priority health objectives, including the provision of technical assistance to national quality control laboratories to operate with good laboratory practices and become accredited in ISO/IEC 17025:2005. The program also conducted workshops to inform manufacturers of second-line tuberculosis drugs how to produce quality-assured medicines by following good manufacturing practices. The PQM program has made significant progress in FY11, including the provision of technical assistance to 20 countries to strengthen national capacity in quality assurance and quality control systems. The program has also conducted numerous workshops to inform manufacturers of second-line tuberculosis drugs how to produce quality-assured medicines by following good manufacturing practices. The PQM program has also made significant progress in raising public awareness about the negative health consequences of using medicines other than those whose quality has been assured. The program has conducted numerous workshops and training sessions to inform healthcare professionals and patients about the importance of quality assurance of medicines. In conclusion, the PQM program has made significant progress in FY11 in supporting USAID priority health objectives in four regions. The program has provided technical assistance to 20 countries to strengthen national capacity in quality assurance and quality control systems. The program has also conducted numerous workshops to inform manufacturers of second-line tuberculosis drugs how to produce quality-assured medicines by following good manufacturing practices.
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Classification
USAID DEC