Implantação e implementação do sistema de gestão de qualidade de boas práticas de fabricação no LABTEC3D

Abstract

The objective of this study was to implement and implement a Quality Management System for Good Manufacturing Practices (LABTEC3D) in compliance with the criteria established by the National Agency of Sanitary Surveillance (ANVISA). A survey was made of the publications concerning the application of quality systems in three-dimensional printing laboratories and a critical reading regarding Good Manufacturing Practices of medical products and products for in vitro diagnostics, standards and resolutions applied to this process, specifically the RDC 16/2013. Then, based on the information obtained, a Manual of Good Manufacturing Practices of LABTEC3D was prepared with the purpose of meeting the requirements of the Quality System, focusing on chapter V of the RDC 16/2013. Finally, the operational procedures performed in LABTEC3D have been developed and documented with the aim of standardizing all processes and allowing them to be performed in the same way, minimizing the risk of failures. This work is expected to be implemented and implemented in LABTEC3D a quality system based on Good Manufacturing Practices presented in RDC 16/2013, through the elaboration of the laboratory quality manual and operating procedures.