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

Combining rifampicin in the same tablet with isoniazid, with or without pyr azinamide, is known to affect the bioavailability of the drug. It is also k nown that many fixed-dose combination (FDC) preparations exist in the marke t which are of inferior quality, but are unknowingly used extensively in tu berculosis treatment programmes in low-income countries with high tuberculo sis caseloads. This has led to joint statements by the International Union Against Tuberculosis and Lung Disease and the World Health Organization (WH O) 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 c omponent of drug duality assurance is to ensure that the infrastructure and logistics required to carry out the operational aspects of quality assuran ce are adequate and sustainable. This paper describes the structures and ma nagement responsibilities required to meet this objective, based on general WHO guidelines for the quality assurance of pharmaceuticals.