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. Good quality medicines are essential to survival, and providing sustainable access to them is imperative. . Under the U.S. Food, Drug, and Cosmetic Act, quality standards established by USP are enforceable by the U.S. Food and Drug Administration (FDA) for medicines and their ingredients manufactured, imported into, or marketed in the United States. Additionally, USP also provides quality standards for articles that are not approved or legally marketed in the United States, but have been approved by a stringent regulatory authority [as defined by the World Health Organization (WHO)] and are used for essential purposes in other parts of the world. For more than 20 years, USP has supported regulatory authorities and the pharmaceutical industry in more than 70 countries and currently has offices in ten; USP’s standards have been used in more than 140 countries.
USP operates ISO 17025 laboratories in Brazil, China, Ghana, and India; the organization also has offices in Switzerland, Ethiopia, Indonesia, Nigeria, and the Philippines. USP-Ghana is home to the Center for Pharmaceutical Advancement and Training (CePAT), a regional leader in the provision of technical assistance and training to professionals in pharmaceuticals regulation and manufacturing in Africa. Established in 2013, CePAT provides training and services in pharmaceutical quality control, GMP, and regulatory systems strengthening. CePAT’s laboratories provide the ideal hands-on setting for quality control training. Since inception, CePAT has trained more than 250 regulators and manufacturers from more than 30 African countries. USP is a longstanding partner of the United States Agency for International Development (USAID), and currently operates the Promoting the Quality of Medicines (PQM) program. The objectives of this program are to provide technical leadership; increase the supply of quality-assured medicines; combat the presence of counterfeit and substandard medicines; and strengthen quality assurance and quality control systems. PQM currently operates in more than 35 countries.
As a global provider of technical assistance, USP works with stakeholders to effectively collaborate towards developing regulatory systems. The organization has many ongoing memorandums of understanding (MOUs) with ministries of health (MOH), as well as with regional networks such as the Asia-Pacific Economic Cooperation (APEC) and the New Partnership for Africa’s Development (NEPAD), as well as key funders such as the U.S. Agency for International Development (USAID) and the Global Fund. USP also has longstanding relationships with key stakeholders such as the World Health Organization (WHO) and the World Bank.
For more information about USP visit
http://www.usp.org.
