IMPLANTAÇÃO DE GESTÃO DE RISCOS DA QUALIDADE EM QUALIFICAÇÃO DE FORNECEDORES: um relato de experiência

Abstract

This paper presents an experience report on the implementation of quality risk management processes, experienced in the context of supplier qualification in the pharmaceutical industry between the months of January and December 2023. Through this narrative, we seek to demonstrate the increase in robustness of the processes in which quality risk management concepts are used during decision making. The experience is theoretically based on the review of the concepts brought by the international guide ICH Q9 R1, as well as the alignment of these concepts with the scheme of cooperation in pharmaceutical inspections (PICs), which was internalized by the National Health Surveillance Agency (BRASIL, 2022). It is believed that the results of this report can contribute to the debate and reflections on quality risk management and its impact on ensuring the safety of patients and consumers of products in the pharmaceutical industry, in the context of supplier qualification.