Where there is an operational DRA, the NTP has to follow the directives of the DRAand work closely with it. The programme has to procure and use only those FDC drugs approved by the DRA. In addition, the NTP has to:
• Request the supplier to submit a copy of the marketing authorization (certificate of registration) issued by the DRA to ensure that the product has been officially registered for use in the exporting country.
• Check with DRA if product is registered in your own country.
• Request the supplier to submit a WHO-type batch certificate (see Annex 3) issued by the manufacturer of the product. AWHO-type Batch Certificate differs from the normal certificate of analysis in that it also provides information on: 1) the specification of the product at the time of batch release and the results of full analysis on the batch in question; 2) whether the product has been registered in the country of manufacturer; 3) the product licence number (registration number); 4) the name and address of the product licence holder etc.
• Make a physical inspection on arrival of the shipment - to verify adherence to contract specifications and spot any gross deficiencies. Also, random samples may be taken from each batch for laboratory testing to confirm the quality of the batch.
• Conduct quality surveillance during distribution - quality surveillance should be carried out once the FDC drugs are in the distribution chain. This involves ensuring that personnel involved are qualified, that storage facilities and transport conditions are appropriate, and that drugs have not expired. If necessary, samples should be taken and tested to confirm that product quality has been maintained.
• Establish a product defects reporting system - a product defects reporting system should be developed for prescribers/health workers, dispensers, store managers, etc., to report suspected or confirmed quality defects. There should be established written procedures and forms for reporting defective FDC drugs. All reports must be carefully reviewed using laboratory testing as required, and the appropriate action taken, including product recalls. The national drug regulatory authority should be informed about the situation.
• Create a recall receiving system - there should be a system to recall defective FDC products from health facilities and distribution outlets promptly. There should be written procedures. Distribution records should be kept complete and up to date to permit an effective recall. Recalls should be initiated promptly. All health facilities and distribution outlets to which FDC drugs have been distributed should be informed promptly of any intention to recall. Recalled products should be kept in a separate place. The quantities recalled should be reconciled with the quantities distributed and a report prepared for submission to the DRA.