Quality assurance is an important part of the drug procurement process, and national TB programme managers should ascertain the quality of anti-TB drugs being purchased. A comprehensive QA programme includes both technical and managerial activities and ensures, among other things, that:
• Drugs are properly selected based on quality, safety and efficacy, are in the correct dosage form, and have the longest possible shelf-life.
• Suppliers selected have acceptable qualifications and quality standard products.
• Drugs received meet the specified quality requirements.
Proper pre-qualification and post-tender monitoring help to eliminate substandard suppliers. Pre-qualification6 is the procedure of evaluating supplier capacity and reputation before bids are solicited for specific drug products. Post-tender monitoring evaluates the suppliers, after the bids have been received, for reliability in delivery of goods (e.g. lead time), product quality, and services including response to enquiries and provision of documents.
6 Information on standard procedures for pre-qualification of suppliers and their products available at: http://www.who.int/medicines/organization/qsm/activities/pilotproc/ppdoc2.doc
More detailed discussion on the quality of anti-TB drug products can be found in section 4.