Diseño del sistema de control de la calidad de los servicios de ensayos biológicos en el Centro de Bioactivos Químicos
Fecha
2014-07-27
Autores
Basallo Torres, Blanca Celia
Título de la revista
ISSN de la revista
Título del volumen
Editor
Universidad Central "Marta Abreu" de Las Villas
Resumen
En este trabajo de tesis se identificaron las particularidades que presenta el control de
calidad en los servicios de ensayos biológicos en el Centro de Bioactivos Químicos que,
dependiendo del tipo de ensayo, debe ajustarse a normativas especiales vigentes. Para
contemplar el Sistema de Gestión de la Calidad resultó indispensable diseñar un sistema
de control de calidad de los servicios que garantice el cumplimiento de los requisitos
regulatorios y del cliente. El procedimiento propuesto para el diseño del sistema de
control de calidad de los servicios de ensayos biológicos cumple con las expectativas de la
investigación, pues permite identificar el estado del proceso de ensayos, las fuentes de
fallo, el establecimiento de los puntos críticos, el diseño de las inspecciones necesarias, así
como la posibilidad de hacer la planificación del sistema de control de la calidad. Se identificaron nueve fuentes de fallo que pueden afectar la calidad del servicio, se definió
el tiempo total de realización del servicio. Finalmente, quedó establecido el diseño del
sistema de control, de la calidad para estos servicios con todos sus elementos: puntos
críticos de control, hoja de verificación para la inspección y planificación del sistema de
control de calidad. Se demostró la efectividad del diseño del sistema de control de la
calidad a los servicios de ensayos biológicos mediante la inspección al protocolo de
investigación en el punto crítico de control uno.
In this thesis work, the peculiarities of the quality control services for bioassays in the Chemical Bioactive Center which, depending on the type of test, must conform to special regulations in place were identified. To complete the system of quality management, it was essential to design a system of quality control services to ensure compliance with regulatory and customer requirements. The proposed procedure for the design of the quality control system for bioassays services meet the expectations of the research , as it allows to identify the status of the testing process , sources of error , the establishment of the critical points , the design of the necessary inspections and the possibility of planning the quality control system. Nine sources of error that can affect the quality of service are identified, the total time of performing the service of biological assays was defined and four critical control points were included, in order to select the control object and create a basis for evaluation of the conformity of the service. Finally, the design of the system for quality control for these services with all its elements was established: critical control points, check sheet for the inspection and planning of the quality control system. The effectiveness of the design for the quality control system for bioassays services by inspecting the research protocol at the critical control point one was demonstrated.
In this thesis work, the peculiarities of the quality control services for bioassays in the Chemical Bioactive Center which, depending on the type of test, must conform to special regulations in place were identified. To complete the system of quality management, it was essential to design a system of quality control services to ensure compliance with regulatory and customer requirements. The proposed procedure for the design of the quality control system for bioassays services meet the expectations of the research , as it allows to identify the status of the testing process , sources of error , the establishment of the critical points , the design of the necessary inspections and the possibility of planning the quality control system. Nine sources of error that can affect the quality of service are identified, the total time of performing the service of biological assays was defined and four critical control points were included, in order to select the control object and create a basis for evaluation of the conformity of the service. Finally, the design of the system for quality control for these services with all its elements was established: critical control points, check sheet for the inspection and planning of the quality control system. The effectiveness of the design for the quality control system for bioassays services by inspecting the research protocol at the critical control point one was demonstrated.
Descripción
Palabras clave
Centro de Bioactivos Químicos (CBQ), UCLV, Ensayos Biológicos, Sistema de Gestión de la Calidad, Buenas Prácticas Farmacéuticas (BPF), Norma ISO/IEC 17025:2006