Implementation of Good Laboratory Practices (NIT-DICLA-035, Inmetro) in a technological platforms network: the Fiocruz experience

摘要

The technological platforms network (TPN) of the Oswaldo Cruz Foundation was developed as the result of the need to provide technical and scientific services to the Brazilian public health and health research networks through the use of high cost, state-of-the-art, multiuser equipment. In order to improve the quality of the services offered, a quality management system (QMS) was implemented in a group of subunits of the TPN. To achieve the planned objectives, a review of all the existing guidelines was carried out first, which led to the choice of a Brazilian guideline: Inmetro NIT-DICLA-035, “Good Laboratory Practices” (GLP). The next steps were the choice of the platform subunits (Pilot Project), the drafting of relevant documentation, and the creation of a quality assurance structure as well as other activities. It was clear that a proper interpretation and understanding of GLP in these platforms could make a difference in the efficacy and effectiveness of the system defined. The expertise gained through the implementation of QMS in the Pilot Project has enabled GLP implementation in the other TPN subunit platforms.