Diseño de un manual de seguridad y buenas prácticas en el laboratorio de análisis y control de medicamentos

Abstract

This document establishes essential information on Good Laboratory Practices (GLP), since they are a set of standards, protocols and practices established by specific organizations such as the FDA (Food and Drug Administration) and the EPA (Environmental Protection Agency). This Laboratory Safety and Good Laboratory Practices Manual specifies the policies of good GLP management followed by the responsibilities of the teacher, student and laboratory technician, as well as some descriptions of the functions they must fulfill. Some laboratory materials that should be acquired by each work group were also detailed, as well as the personal clothing. The classification of the different types of risks was also established, and from a set of biosafety standards, the thirty most important ones were selected for the laboratory of analysis and control of medicines, which will guarantee the quality, safety and proper functioning of the laboratory, since in this way the aim is to generate efficient and quality results, but above all to protect the health of the personnel and students. This manual is primarily aimed at the community of the Technical University of Machala, for this reason the information will be disseminated through digital media being this a free access platform, so that will be achieved to promote the teaching and learning of the established sections, in order to create a more favorable environment for learning, and thus ensure the integrity and safety of students, teachers, laboratory technicians and cleaning staff.