Actividades desempeñadas en el área de Aseguramiento de la Calidad de un laboratorio nacional, 2019-2020
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El presente informe tiene como objetivo mostrar las diferentes actividades que se llevaron a cabo durante el desarrollo de las prácticas pre-profesionales en el área de Aseguramiento de la Calidad de un Laboratorio Nacional, 2019- 2020. El desarrollo de las prácticas pre-profesionales se distribuyó en tres partes: La primera parte implicó una inducción general, referente a la forma operativa del laboratorio, así como diversas capacitaciones referentes al manejo de la documentación correspondiente al área de Aseguramiento de la Calidad del laboratorio. La segunda, comprendió actividades vinculadas al proceso de manufactura del laboratorio: Revisión de archivos técnicos, en los cuales se describe de forma detallada la fabricación de los medicamentos, visitas a las áreas de Fabricación de Líquidos, Sólidos y Semi Sólidos galénicos para conocer los procesos de manufactura de los mismos, dichas visitas, sirvieron para demostrar que el laboratorio fabrica medicamentos, basándose en las normas de Buenas Prácticas de Manufactura (BPM), las cuales son sinónimo de calidad. Otra de las actividades desempeñadas fue el control del correcto llenado de los registros, a nivel de todo el laboratorio. Por último, la tercera parte consistió en la elaboración y actualización de documentos, procedimientos e instructivos, así como el control del cumplimiento de diversos programas, los cuales sirven de base para el funcionamiento del laboratorio, ya que en éstos se detalla de forma específica como llevar a cabo las diferentes actividades dentro de cada una de las áreas que forman parte del laboratorio y en qué periodos deben de cumplirse para evitar cualquier inconveniente.
ABSTRACT The objective of this report is to show the different activities that were conducted during the development of the pre-professional practices in Quality Assurance of a National Laboratory, 2019-2020. The development of the pre-professional practices was distributed in three parts: The first part implied a general induction, referring to the operative form of the laboratory, as well as diverse trainings referring to the handling of the documentation corresponding to the area of Quality Assurance of the laboratory. The second part included activities related to the laboratory's manufacturing process: review of technical files, which describe in detail the manufacture of medicines, visits to the Liquid, Solid and Semi-Solid Galenic Manufacturing areas to learn about their manufacturing processes. These visits served to demonstrate that the laboratory manufactures medicines based on the Good Manufacturing Practices (GMP) standards, which are synonymous with quality. Another of the activities conducted was the control of the correct filling out of records throughout the laboratory. Finally, the third part consisted of the preparation and updating of documents, procedures, and instructions, as well as the control of compliance with various programs, which serve as the basis for the operation of the laboratory, since they detail specifically how to carry out the different activities within each of the areas that are part of the laboratory and in what periods must be met to avoid any inconvenience
ABSTRACT The objective of this report is to show the different activities that were conducted during the development of the pre-professional practices in Quality Assurance of a National Laboratory, 2019-2020. The development of the pre-professional practices was distributed in three parts: The first part implied a general induction, referring to the operative form of the laboratory, as well as diverse trainings referring to the handling of the documentation corresponding to the area of Quality Assurance of the laboratory. The second part included activities related to the laboratory's manufacturing process: review of technical files, which describe in detail the manufacture of medicines, visits to the Liquid, Solid and Semi-Solid Galenic Manufacturing areas to learn about their manufacturing processes. These visits served to demonstrate that the laboratory manufactures medicines based on the Good Manufacturing Practices (GMP) standards, which are synonymous with quality. Another of the activities conducted was the control of the correct filling out of records throughout the laboratory. Finally, the third part consisted of the preparation and updating of documents, procedures, and instructions, as well as the control of compliance with various programs, which serve as the basis for the operation of the laboratory, since they detail specifically how to carry out the different activities within each of the areas that are part of the laboratory and in what periods must be met to avoid any inconvenience
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Keywords
Aseguramiento, BPM, calidad, laboratorio, fabricación