Market Analysis for Implementing Good Laboratory Practices at the SENAI Institute of Innovation in Advanced Health Systems (ISI-SAS) of SENAI CIMATEC

Abstract

Good Laboratory Practices (GLP) comprise a quality system encompassing organizational processes and conditions under which non-clinical safety studies for human health and the environment are planned, developed, monitored, recorded, archived, and reported. The objective of this work was to analyze the market to guide decision-making regarding the implementation of GLP at CIMATEC's ISI-SAS, following NIT-Dicla-035, with a focus on achieving Conformity with the Principles of Good Laboratory Practices recognized by Cgcre of Inmetro. This study showed that the prevalence of Test Facilities in Brazil's South and Southeast regions became evident. Most companies that responded to the questionnaire expressed interest in GLP studies, particularly cytotoxicity. By comparing the requirements of NIT-Dilca-035 with the structure of ISI-SAS, it was determined that implementing GLP in this sector is feasible, leading to the initiation of Good Laboratory Practices implementation in this area.