Ongoing Monitoring of Antiretroviral Products as Part of WHO's Prequalification Project

Abstract

The supply of quality medicines used in the treatment of HIV/AIDS has become a major concern at both international and country level. The Prequalification Project, set up in 2001, is a service provided by the World Health Organization (WHO) to facilitate access to medicines that meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis. The main purpose of the project with respect to HIV/AIDS is to assess the quality, safety and efficacy of medicines (both antiretrovirals [ARVs] and medicines for HIV/AIDS care) in accordance with international standards and to ensure that good manufacturing practice is applied at the manufacturing sites. The assessment further includes reviewing bioequivalence data and inspecting respective contract research organisations where the clinical trials were conducted for compliance with good clinical practice. Only products meeting all the requirements are listed on the prequalified products list. As part of the quality assurance element of the Prequalification Project, samples of 33 HIV/AIDS products, of which 24 were ARVs and 9 were for HIV/AIDS care, submitted for prequalification were subjected to quality control (QC) testing in 2002. This was followed by a second round of QC testing during 2004 on 11 ARV products, including comparison of dissolution profiles of generic products against the relevant innovator products. Some of the products tested appear on the current Prequalification list. All samples but one met the shelf-life specifications for content and, where tested, for identification of the active pharmaceutical ingredient, dissolution, average mass and uniformity of mass. One product sample did not meet the content specifications; however, the number of tablets required for assay testing and consequently also for confirmative retesting was insufficient, and therefore the result cannot be considered conclusive. Another product did not meet the requirements for similarity of dissolution profile against the innovator product, though it proved to be rapidly dissolving.