Technical Assistance Program (TAP)
In February 2011, USP launched a pilot Technical Assistance Program (TAP) to provide developing countries with tools and training to increase their capacity to test the quality of medicines provided for their citizens.
Typically, USP and other pharmacopeias sell reference and documentary standards to pharmaceutical manufacturers and quality control laboratories around the world for testing purposes. Constrained by limited resources, the national laboratories in developing countries may resort to using unreliable or outdated standards, and/or may not be equipped to offer their analysts the scientific training required to appropriately analyze medicines. As such, these laboratories may not obtain accurate results when they test questionable samples—a serious gap in quality assurance that can lead to severe health outcomes for patients, including prolonged disease and death. TAP aims to make such measures unnecessary, because it provides USP standards at no cost to participants.
Specifically, TAP equips countries with a comprehensive package of
- Pharmaceutical reference standards (very pure physical samples used as reference chemicals to test medicines)
- Documentary standards (written specifications)
- Technical training (on topics such as HPLC and other analytical methods and the effective use of standards)
Countries in the pilot are Ethiopia, Ghana, Kenya, Senegal, Sierra Leone, and Egypt—all of whom have committed to improving public health through the activities of their medicine quality control laboratories. Many of these countries have been working with USP’s Promoting the Quality of Medicines (PQM) program, funded by USAID, which collaborates with local authorities to detect and remove substandard and counterfeit medicines from the market through technical support and public awareness outreach. TAP aims to complement and reinforce this work, although it is managed separately.
Assessment & Future
At the end of the pilot period, USP and the participating labs will assess progress in such areas as number and variety of drug samples tested; number of substandard or counterfeit drugs detected; and improved access to quality medicines. If the pilot is successful, the program may be renewed or expanded with the initial participants and extended to other countries.
- Vice Director of NIDQC, Dr. Tran Viet Hung, Explains the Benefits of Participating in TAP (YouTube video)
Media coverage of TAP: