Planejamento e adaptação no layout de um laboratório farmacêutico de fitofármacos

Abstract

This study analyzes the process of designing, structuring, and regulating a pharmaceutical industry focused on the production of cosmetics, sanitizing products, and, in the future, phytopharmaceuticals derived from Cannabis sativa. The justification lies in the need to comply with the regulations of the Brazilian Health Regulatory Agency (Anvisa) and Good Manufacturing Practices (GMP), ensuring quality and safety in plant-based production processes. The main objective was to develop and implement an industrial laboratory in accordance with sanitary regulations, considering technical and safety requirements. The methodology involved technical and regulatory research, followed by the planning of the production layout, adopting a U-shaped cellular model to enhance operational efficiency, traceability, and waste reduction. Equipment selection was guided by performance, safety, and spatial adequacy, while structural specifications prioritized smooth, non-porous, and easy-to-clean surfaces, as well as pass-through systems to prevent cross-contamination. The project also complied with Brazilian Regulatory Standards NR 6, NR 9, and NR 32, and ABNT technical standards, ensuring occupational safety and technical conformity. As a result, the laboratory was successfully implemented and certified by the Municipal Health Surveillance Agency under Level 1, enabling the production of cosmetics and sanitizers. The company is technically prepared to expand into phytopharmaceutical manufacturing, awaiting regulation of Cannabis sativa cultivation by the Ministry of Agriculture (MAPA) and Anvisa’s authorization to operate under Levels 3 and 4. It is concluded that the work consolidated solid technical and structural foundations, with safe and efficient production processes aligned with legal requirements and growth opportunities in the national pharmaceutical sector.