Combining rifampicin in the same tablet with isoniazid, with or without pyrazinamide, is known to affect the bioavailability of the drug. It is also known that many fixed-dose combination (FDC) preparations exist in the market which are of inferior quality, but are unknowingly used
extensively in tuberculosis treatment programmes in low-income countries with high tuberculosis caseloads. This has led to joint statements by the International Union Against Tuberculosis and Lung Disease and the World Health Organization (WHO) pointing out that anti-tuberculosis FDCs should
only be used in National Tuberculosis Programmes if the bioavailability of at least the rifampicin component has been demonstrated. Through the FDC Quality Assurance Project launched by the WHO in 1997, a strategy was proposed which aimed to provide specific guidance to ensure the improved
quality of such preparations, and in particular the bioavailability of the rifampicin component. A crucial component of drug quality assurance is to ensure that the infrastructure and logistics required to carry out the operational aspects of quality assurance are adequate and sustainable.
This paper describes the structures and management responsibilities required to meet this objective, based on general WHO guidelines for the quality assurance of pharmaceuticals.
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Document Type: Regular Paper
National Tuberculosis Research Programme, Medical Research Council, Pretoria, South Africa
Communicable Diseases Cluster, World Health Organization, Geneva, Switzerland
Publication date: 01 November 1999
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