Elaboração do programa de monitoramento ambiental de partículas viáveis em áreas produtivas de uma indústria farmacêutica

Abstract

Good Manufacturing Practices (GMP) are fundamental guidelines that ensure the production of safe and high-quality products, encompassing training processes, facility qualification, environmental condition monitoring, and procedures aligned with the pharmaceutical quality system. Among these guidelines, the implementation of environmental monitoring in pharmaceutical production areas aims to detect deviations from environmental limits, triggering investigations and risk assessments related to product quality. This study aimed to develop an environmental monitoring program for viable particles in a pharmaceutical industry, using the Hazard Analysis and Critical Control Points (HACCP) tool for risk assessment. An interdisciplinary team identified hazards in production areas and evaluated them based on the criteria of severity, probability, and detection. A total of 213 rooms were visited, with four types of hazards identified. Among them, the exposure of raw materials, in-process, or finished products was classified as high risk, justifying the implementation of monitoring. The proposed approach highlights the importance of integrating systematic risk assessment methodologies into environmental monitoring planning, optimizing resources, and ensuring compliance with Good Manufacturing Practices and current regulations.