Implementation of Good Laboratory Practices (NIT-DICLA-035, Inmetro) in a technological platforms network: the Fiocruz experience |
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Authors: | Renata Almeida de Souza Cassia Docena Patricia dos Santos Silva Ana Beatriz Moraes da Silva Ana Paula Oliveira Brum |
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Affiliation: | 1. Centre for Technological Development in Health (CDTS), Oswaldo Cruz Foundation (Fiocruz), Ministry of Health, National Institute of Science and Technology for Innovation in Neglected Diseases (INCT/IDN), Rio de Janeiro, RJ, 21040-900, Brazil 2. Ministry of Development, Industry and Foreign Trade, National Institute of Metrology, Quality and Technology, INMETRO, Rio de Janeiro, RJ, 20251-021, Brazil 3. Oswaldo Cruz Foundation, Ministry of Health, The Aggeu Magalh?es Research Center, Recife, PE, 50670-420, Brazil 4. Oswaldo Cruz Foundation (Fiocruz), Ministry of Health, Sergio Arouca National School of Public Health, Rio de Janeiro, RJ, 21041-210, Brazil
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Abstract: | 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. |
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