Panorama Brasileiro do Programa de Boas Práticas de Laboratório. Impacto na redução do uso de animais

Abstract

Good Laboratory Practice (GLP), a quality system covering the organizational process and the conditions under which non-clinical studies are conducted, aims to ensure uniformity, consistency, reliability, reproducibility, quality, and integrity of the safety tests. The Brazilian Institute of Environment and Renewable Natural Resources formally introduced GLP in 1994. INMETRO initiated the GLP Program in 1995 for recognition and tracking on the basis of procedures, regulations, administrative and legal rules that establish guidelines, policies and directions to act with full responsibility and authority as the Brazilian monitoring authority to the principles of GLP. GLP studies are recognized by members and non-member countries with full membership to act according to the Organisation for Economic Co-operation and Development (OECD) Mutual Acceptance of Data (MAD) agreement and promote reduction in the number of animals used because of non-repetition of tests and adoption of validated alternative methods. In Brazil, there are 31 active GLP facilities, of which 5 perform in vivo tests. Normative Resolution 17/2014 of the National Council for the Control of Animal Experimentation establishes that animal tests that have validated alternative methods recognized by the Council will be replaced within 5 years with the expansion of BPL-based laboratories.