Cumplimiento de las buenas prácticas de almacenamiento en droguería Galuma de Trujillo-Perú en el año 2022
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El presente informe tiene como objetivo determinar el nivel de cumplimiento de las buenas prácticas de almacenamiento en droguería Galuma de Trujillo-Perú en el año 2022. Para el desarrollo del informe se analizó el acta de autoinspección para la certificación de las BPA, los parámetros a evaluación fueron: Sistema de gestión de calidad, personal, instalaciones, equipos e instrumentos, almacén, documentación, reclamos, retiro de productos y auto- inspecciones; los cuales se tabularon para determinar las no conformidades y/u observaciones y proceder al análisis de riesgo. Posterior a ello, se clasificó según acta en; C: critico, M: mayor, m: menor e I: informativo. El resultado del nivel de cumplimiento para la droguería fue del 91%, encontrándose en un nivel alto. Se determinó también el nivel de cumplimiento de cada parámetro observando así; un 91.67% para sistema de aseguramiento de calidad; el 92.86% para la evaluación del personal; el 92.21% para la evaluación de instalaciones, equipos e instrumentos y el 91.3% para documentación los cuales tienen un nivel de cumplimiento alto. Los parámetros de almacén, reclamos y auto-inspecciones, obtuvieron el 97.44% y 100% para ambos respetivamente; los cuales tienen un nivel de cumplimiento muy alto. El parámetro de retiro de mercado obtuvo un 62.5% siendo este un nivel medio. Se concluye que, luego de analizado los riesgos se propone acciones correctivas en base a las observaciones y/o no conformidades las cuales fueron de tipo M (mayor).
ABSTRACT The objective of this report is to determine the level of compliance with good storage practices in the Galuma drugstore in Trujillo-Peru in the year 2022. For the development of the report, the self-inspection act for the certification of BPA, the parameters The evaluation were: Quality management system, personnel, facilities, equipment and instruments, warehouse, documentation, claims, withdrawal of products and self-inspections; which were tabulated to determine the non-conformities and/or observations and proceed to the risk analysis. After that, it was classified according to the minutes in; C: critical, M: major, m: minor and I: informative. The result of the level of compliance for the drugstore was 91%, being at a high level. The level of compliance with each parameter was also determined, observing as follows; 91.67% for the quality assurance system; 92.86% for personnel evaluation; 92.21% for the evaluation of facilities, equipment and instruments and 91.3% for documentation, which have a high level of compliance. The warehouse parameters, claims and self-inspections, obtained 97.44% and 100% for both respectively; which have a very high level of compliance. The market withdrawal parameter obtained 62.5%, this being a medium level. It is concluded that, after analyzing the risks, corrective actions are proposed based on the observations and/or non-conformities which were of type M (major).
ABSTRACT The objective of this report is to determine the level of compliance with good storage practices in the Galuma drugstore in Trujillo-Peru in the year 2022. For the development of the report, the self-inspection act for the certification of BPA, the parameters The evaluation were: Quality management system, personnel, facilities, equipment and instruments, warehouse, documentation, claims, withdrawal of products and self-inspections; which were tabulated to determine the non-conformities and/or observations and proceed to the risk analysis. After that, it was classified according to the minutes in; C: critical, M: major, m: minor and I: informative. The result of the level of compliance for the drugstore was 91%, being at a high level. The level of compliance with each parameter was also determined, observing as follows; 91.67% for the quality assurance system; 92.86% for personnel evaluation; 92.21% for the evaluation of facilities, equipment and instruments and 91.3% for documentation, which have a high level of compliance. The warehouse parameters, claims and self-inspections, obtained 97.44% and 100% for both respectively; which have a very high level of compliance. The market withdrawal parameter obtained 62.5%, this being a medium level. It is concluded that, after analyzing the risks, corrective actions are proposed based on the observations and/or non-conformities which were of type M (major).
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Keywords
Buenas prácticas de almacenamiento, Estabilidad, Inspección, Plan de acción, Procedimiento operativo estándar.