Treatment of TB with poor quality drugs will not only result in treatment failures but can lead to the development of drug resistance. This will have a deleterious effect on the health of the wider population. Ensuring the quality, safety and efficacy of all anti-TB drugs, including FDCs, used in a NTP, is therefore of utmost importance in combating the disease.
Safety, efficacy and quality are built into a product at the time of its design and production. This means that quality, safety and efficacy of FDC drugs are determined by the manufacturing process i.e. by compliance of the manufacturer with the requirements of good manufacturing practices (GMP) and pharmacopoeial specifications. However, a FDC product which has been produced in full compliance with GMP requirements and has passed all laboratory tests, may lose its quality and eventually become ineffective if the packaging, storage and transportation conditions are substandard. Consequently, in order to ensure that FDC products are safe, effective and of good quality, national TB programmes must establish a QA system addressing the following issues:
• Production of FDC products in accordance with GMP requirements;
• Storage, transport and distribution of FDC products under appropriate conditions (i.e. conditions stated by the manufacturer and appearing on the labels of the products).