Avaliação dos pontos críticos de contaminação por endotoxinas bacterianas na produção de medicamentos veterinários injetáveis

Abstract

In 2015, agribusiness covered 21% of the GDP and veterinary pharmaceuticals and immunobiological products contributed to approximately R$ 4.5 billion, 0.36% of Brazilian agribusiness. Quality control is a tool capable of anticipating potential problems and verifying that these products meet the quality and identity specifications required for commercialization. Considering that bacterial endotoxins are one of the main contaminants of injectable pharmaceutical products, the objective of this work was to identify and evaluate, in a veterinary pharmaceutical plant located in the metropolitan area of Belo Horizonte, MG, possible critical points of endotoxin contamination in its line, and to stablish operational procedures that guarantee the desired product quality. Potability parameters and endotoxin detection were used to evaluate the water quality used in the process and sterility and endotoxin detection tests were the final product evaluation parameters. In order to reach the proposed objective, water treatment system and production line were represented schematics, so that possible critical contamination points were indicated and measures presented able to mitigating or controlling / eliminating possible foci. The schematics also allowed a systemic view of the process and establishment of a decision making risk management plan without compromising the production process. Thus, risk mapping and assessment can contribute to the development of more robust production processes, reducing the potential contamination risk, lowering economic loss for the industry and ensuring the final product is within the acceptable specifications for quality.