Laboratory control of biological products in Latin America

Abstract

The manufacture of safe effective biological products in sufficient quantities to protect the entire population presents many problems in Latin America. The best way of ensuring such production would be to establish thorough control testing mechanisms. Ideally, no regulatory program should be considered complete without three tiers of controls: «in-process» production controls; «internal» controls by the manufacturer that monitor the production section; and «national» controls by the government that monitor the manufacturer. Although the standards maintained by some biologicals manufacturing centers in Latin America are very high, no country has yet established a full-fledged three-level control system of this kind. However, two countries have decided to employ such a system and are now close to achieving that goal. Perhaps the most essential facility in any national control program is the National Biologics Control Laboratory. This laboratory must be effectively organized, properly staffed, and backed by strong implementing legislation enabling it to perform its assigned tasks. In the past, lack of such a facility has created serious problems for biologicals manufacturing efforts in Latin America. Aware of this, a number of countries are now in the process of setting up and developing effective national laboratories of this kind (Au)