Process integration of quality management systems, occupational health and safety, environment in pharmaceutical laboratories: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02182 | Published on: 21/12/2023

• Autor(a) principal: Mendonça Horato, Caroline
• Data de Publicação: 2023
• Outros Autores: Carlos Santos da Costa, Jorge
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2182
• topic: Sistema de Gestão Integrada; Indústria Farmacêutica; Qualidade Farmacêutica; Integrated Management System; Pharmaceutical Industry; Pharmaceutical Quality

Introduction: Due to health regulations, the quality management system in pharmaceutical companies is compulsory and regularly evaluated by health bodies in relation to GMP supervision. However, health regulation does not extend to concerns about occupational health and safety and the environment. It is important to mature the management systems for these issues. Objective: To study the integration potential of occupational health and safety systems, environment and quality of pharmaceutical laboratories, considering the assumptions, regulatory requirements and particularities of the segment. Method: Exploratory and descriptive study carried out through documentary and field research. Matrixes of requirements of the thematic standards were built and mapped, and actions for integration were proposed. After that, they were submitted to the evaluation by specialists. Results: Comparing the RDC 301/2019 and 652/2022 with the ICH Q10, ISO 9001, 45001 and 14001, it was found that for 71% of the themes and normative requirements, there is synergy and total convergence between the requirements. For the other items, it is necessary to adapt processes and conducts. The propositions listed by the authors to address the gaps were positively validated in relation to achieving implementation feasibility in about 90%. In relation to the positive benefit, the evaluation was unanimous in 100%, and for the implementation of the resources listed, in 66% of the points there is a need for great institutional effort. Conclusions: The integration of a management system that incorporates the themes quality, health and safety and the environment is possible and beneficial for the pharmaceutical industry and supports the definition of strategies, prioritization of actions and allocation of resources.