Availability of quality fixed-dose combinations for the treatment of tuberculosis: what can we learn from studying the World Health Organization's vaccine model?
OBJECTIVE: To provide guidance for the development of strategies for quality assurance of FDCs.
DESIGN: This review examines the WHO strategies for and experience with quality assurance and supply of vaccines.
RESULTS: Several elements in the strategies for quality assurance and supply of vaccines may be applicable for FDCs. At national level, the important strategies are to strengthen National Regulatory Authorities (NRA) and procurement systems and develop planning activities. Stressing quality assurance of FDCs in training activities for regulatory personnel and recommending that aid agencies require adherence to quality assurance policies as conditions for support would promote the implementation of quality assurance of FDCs at country level. At the global level, pre-qualification of manufacturers of FDCs should be explored as a mechanism to assure quality. The pre-qualification process should include evaluation of product files, initial testing for compliance and consistency of specifications, and site visits to producers and NRAs. The vaccine model defines criteria for reassessment that can be used for FDCs.
Document Type: Regular Paper
Affiliations: 1: Department for Endemic Diseases Control, Prevention and Eradication, Communicable Diseases Cluster (CDS), World Health Organization, Geneva, Switzerland 2: Department for Vaccines and other Biologicals (V&B), Health Technology and Pharmaceuticals Cluster (HTP), World Health Organization, Geneva, Switzerland
Publication date: 1999-11-01
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.
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