Where there is no DRA, or there is a DRA but no operational drug registration system, the responsibility to ensure that the FDC products used are manufactured in accordance with GMP requirements and that the products are safe, efficacious and of good quality, will be that of the national TB programme. To do this, the NTP has to create a QA system of its own. This will consist of recruiting a qualified pharmacist to be responsible for QA of procured drugs and for requesting from the supplier a WHO- type certificate issued in accordance with the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, which provides licensure status of the product and inspection status of the manufacturer (see section 4.4). Two types of certificate are to be requested within the scheme9:
• A Certificate of a Pharmaceutical Product (product certificate) issued by the DRA in the exporting country. This certificate contains the name and dosage form of the product, the INN and amount of active ingredient(s) per unit dose, name and address of product holder and/or manufacturing facility, the product formula (complete composition including all excipients), and product information for health professionals and for the public as approved in the exporting country.
• A Batch Certificate of a Pharmaceutical Product to confirm that individual batches conform to quality and other specifications (normally issued by the manufacturer). This document is a vital instrument in drug procurement and usually a mandatory element of the tender document.
9 Further information: Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products. A Manual for a Drug Regulatory Authority. Geneva, World Health Organization, 1998 (Regulatory Support Series, No.5, WHO/DMP/RGS/98.5). Also available at URL: http://www.who.int/medicines/library/qsm/manual-on-marketing/multisource-contents.html
In addition to requesting the information above, the NTP QA officer should:
• Carry out physical inspections - post-shipment inspections - every time consignments arrive, to verify that the goods meet the specifications (i.e. compare the supplier's invoice with the original purchase order/contract).
• Conduct quality surveillance during distribution, e.g. make sure the drugs are appropriately stored.
• Establish a defects reporting system.
• Create a product recall system.
Where creating a QA system is not applicable, the NTP should procure anti-TB medicines from pre-qualified sources that guarantee quality, safety and efficacy of the products and comply with GMP. Wherever possible, the NTP and its qualified pharmacist should conduct a site inspection to ensure that the manufacturer complies with current GMP requirements. The WHO guidelines on GMP can be applied.