Evaluación del proceso de almacenamiento de dispositivos médicos de una droguería nacional
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Date
2021
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Journal ISSN
Volume Title
Publisher
Universidad Nacional de Trujillo
Abstract
El presente informe tiene como objetivo evaluar el proceso de almacenamiento de dispositivos médicos de una droguería nacional. La droguería cuenta con un almacén certificado en Buenas Prácticas de Almacenamiento, la cual fue analizada para realizar las acciones correctivas pertinentes a los indicadores de los ocho factores: Sistema de aseguramiento de calidad, personal, instalaciones, equipos e instrumentos, almacén, documentación, manejo de reclamos, retiro del mercado y autoinspecciones; considerados en la guía de inspección para droguerías, almacenes especializados y almacenes aduaneros que almacenan productos farmacéuticos, dispositivos médicos y productos sanitarios, según normativa N° 132-20157MINSA; aplicando la metodología se obtuvo entre los factores más resaltantes con un nivel de cumplimiento de 75% en el personal (medio), 93,94 % en instalaciones, equipos e instrumentos (alto) y 80 % en el factor de documentación (alto) y 100 % con un nivel de cumplimiento alto en el sistema de aseguramiento de calidad, almacén, reclamos, retiro de mercado y autoinspecciones correspondientemente, por lo tanto se concluye que la Droguería en estudio tiene un alto nivel de cumplimiento de 93,62 % (alto).
ABTRACT The present work aims to evaluate the storage process of medical devices in a national drugstore. The drugstore has a warehouse certified in Good Storage Practices, which was analyzed to carry out the pertinent corrective actions to the indicators of the eight factors: Quality assurance system, personnel, facilities, equipment and instruments, warehouse, documentation, management claims, recall and self-inspections; considered in the inspection guide for drug stores, specialized warehouses and customs warehouses that store pharmaceutical products, medical devices and sanitary products, according to regulation N° 132-20157MINSA; Applying the methodology, it was obtained among the most outstanding factors with a level of compliance of 75% in the personnel (medium), 93.94% in facilities, equipment and instruments (high) and 80% in the documentation factor (high) and 100% with a high level of compliance in the quality assurance system, warehouse, claims, recall and self-inspections correspondingly, therefore it is concluded that the drug store under study has a high level of compliance of 93.62% (high).
ABTRACT The present work aims to evaluate the storage process of medical devices in a national drugstore. The drugstore has a warehouse certified in Good Storage Practices, which was analyzed to carry out the pertinent corrective actions to the indicators of the eight factors: Quality assurance system, personnel, facilities, equipment and instruments, warehouse, documentation, management claims, recall and self-inspections; considered in the inspection guide for drug stores, specialized warehouses and customs warehouses that store pharmaceutical products, medical devices and sanitary products, according to regulation N° 132-20157MINSA; Applying the methodology, it was obtained among the most outstanding factors with a level of compliance of 75% in the personnel (medium), 93.94% in facilities, equipment and instruments (high) and 80% in the documentation factor (high) and 100% with a high level of compliance in the quality assurance system, warehouse, claims, recall and self-inspections correspondingly, therefore it is concluded that the drug store under study has a high level of compliance of 93.62% (high).
Description
Keywords
Buenas Prácticas de Almacenamiento, droguería, calidad. dispositivos
médicos.