Free Content Structures required, roles and responsibilities in maintaining laboratories for quality assurance of anti-tuberculosis fixed-dose combinations in accordance with the IUATLD/WHO statement

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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.

Keywords: bioavailability; fixed-dose combinations; laboratories; quality assurance; rifampicin

Document Type: Regular Paper

Affiliations: 1: National Tuberculosis Research Programme, Medical Research Council, Pretoria, South Africa 2: Communicable Diseases Cluster, World Health Organization, Geneva, Switzerland

Publication date: November 1, 1999

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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