Mejoramiento de los Servicios de Ensayo en el Laboratorio de Control de la Calidad del Centro de Bioactivos Químicos
Fecha
2011-07-25
Autores
Quintana Fernández, Adalberto
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ISSN de la revista
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Editor
Universidad Central "Marta Abreu" de Las Villas
Resumen
El Centro de Bioactivos Químicos (CBQ) se dedica entre otros objetivos, a la
fabricación y comercialización de productos farmacéuticos; este centro tiene entre
sus principales aspiraciones la certificación del Vitrofural (fondo exportable), debido
a lo cual necesita acreditar los ensayos de control de la calidad de este producto. El
CBQ cuenta con un sistema integrado de gestión de la calidad ISO-BPF, sin
embargo, este centro no incluye en la base regulatoria del sistema el cumplimiento
de la norma NC-ISO/IEC 17025: 2006.
Esta investigación tiene como objetivo mejorar los servicios de ensayos en el
laboratorio de control de calidad del Centro de Bioactivos Químicos para contribuir al
cumplimiento de la norma NC-ISO/IEC 17025:2006. Mediante el desarrollo de la
investigación se realiza un diagnóstico que permite establecer el estado de
cumplimiento de la norma e identificar los principales problemas que afectan su
cumplimiento. Para el desarrollo de la investigación se utilizan las herramientas
básicas y nuevas de gestión de la calidad, la auditoría y se emplean los criterios de
Juran para la planificación del control de la calidad.
Como resultado de la investigación se propone un plan de mejoramiento que
constituye una guía resumida y práctica para el mejoramiento de los servicios de
ensayo y se diseña el control de la calidad de los ensayos de control de la calidad
del Vitrofural, que constituye el cumplimiento de una de las medidas del planpropuesto.
Esta investigación provee al laboratorio de un método de evaluación que garantiza
la toma de decisiones para corregir el problema, evitar consignar resultados
incorrectos e identificar oportunidades de mejora y contribuye con el cumplimiento
de los requisitos de la norma NC-ISO /IEC 17025:2006 con vistas a la acreditación
de los ensayos.
Bioactivos Químicos's Center ( CBQ ) dedicates itself between other objectives, to manufacture and commercialization of pharmaceutical products; This center has between its principal aspirations the Vitrofural's certification ( exportable bottom ), due to which you need to credit the essays of control of the quality of this product. The CBQ counts on a system integrated of step of quality ISO BPF, however, this center does not include in the system's regulatory base the fulfillment of the standard NC ISO/IEC 17025: 2006. This investigation aims at improving the services of essays at the laboratory of quality control of Bioactivos Químicos's Center to contribute to the fulfillment of the standard NC ISO/IEC 17025:2006. A diagnosis that it enables accomplishes establishing the status of fulfillment of the standard itself by means of the development of investigation and to identify the principal problems that affect your fulfillment. They use the quality's basic and new tools of step, the auditing for the development of investigation and they use Juran's criteria for the planning of the control of quality. You set yourself a plan of improvement that constitutes a summarized and practical guide for the improvement of the services of essay and designs the control of the quality of the essays of control of the quality of the Vitrofural, that constitutes the fulfillment of an one belonging to the measures of the proposed plan itself as a result of investigation. This investigation supplies the laboratory with a procedure of evaluation that it guarantees the decision making to correct the problem, avoiding to consign proven to be incorrect and identifying improving opportunities and NC contributes with the fulfillment of the requirements of the standard ISO /IEC 17025:2006 with an eye to the accreditation of the essays.
Bioactivos Químicos's Center ( CBQ ) dedicates itself between other objectives, to manufacture and commercialization of pharmaceutical products; This center has between its principal aspirations the Vitrofural's certification ( exportable bottom ), due to which you need to credit the essays of control of the quality of this product. The CBQ counts on a system integrated of step of quality ISO BPF, however, this center does not include in the system's regulatory base the fulfillment of the standard NC ISO/IEC 17025: 2006. This investigation aims at improving the services of essays at the laboratory of quality control of Bioactivos Químicos's Center to contribute to the fulfillment of the standard NC ISO/IEC 17025:2006. A diagnosis that it enables accomplishes establishing the status of fulfillment of the standard itself by means of the development of investigation and to identify the principal problems that affect your fulfillment. They use the quality's basic and new tools of step, the auditing for the development of investigation and they use Juran's criteria for the planning of the control of quality. You set yourself a plan of improvement that constitutes a summarized and practical guide for the improvement of the services of essay and designs the control of the quality of the essays of control of the quality of the Vitrofural, that constitutes the fulfillment of an one belonging to the measures of the proposed plan itself as a result of investigation. This investigation supplies the laboratory with a procedure of evaluation that it guarantees the decision making to correct the problem, avoiding to consign proven to be incorrect and identifying improving opportunities and NC contributes with the fulfillment of the requirements of the standard ISO /IEC 17025:2006 with an eye to the accreditation of the essays.
Descripción
Palabras clave
Gestión de la Calidad, Centro de Bioactivos Químicos (CBQ), UCLV