Nivel de Cumplimiento de las Buenas Prácticas de Almacenamiento en una Droguería de Dispositivos Médicos, 2020
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Date
2021
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Universidad Nacional de Trujillo
Abstract
En el presente informe, se evaluó el Nivel de Cumplimiento de las Buenas Prácticas de Almacenamiento en una Droguería de Dispositivos Médicos, 2020 en base al porcentaje de cumplimiento de los 8 parámetros indicados en el Documento técnico: Manual de buenas prácticas de almacenamiento de productos farmacéuticos, dispositivos médicos y productos sanitarios en Laboratorios, Droguerías, Almacenes Especializados y Almacenes Aduaneros, RM N°132-2015/MINSA. Para ello, se realizó una autoinspección utilizando el formato del Acta de inspección para Droguerías, Almacenes especializados y Almacenes Aduaneros que almacenan productos farmacéuticos, dispositivos médicos y productos sanitarios y el acta de inspección de la ultima recertificación para comparar los resultados obtenidos e identificar las no conformidades. Se clasificó los resultados en un nivel de cumplimiento alto valores ≥ al 80%; nivel medio, para valores entre 50% al 79%; y nivel de cumplimiento bajo a valores < al 50%. Al terminar la autoinspección, se tabularon los resultados y se obtuvo un porcentaje de cumplimiento del 89.19%, considerándose un nivel de cumplimiento alto, así mismo, de los 8 parámetros analizados, solo 1, autoinspecciones, cumplió al 100%, 6 parámetros obtuvieron porcentajes mayores al 90% y solo 1, quejas y reclamos, obtuvo el porcentaje más bajo 75%. Al comparar los resultados de la ultima recertificación, año 2019, y la autoinspección, año 2020, de forma global los resultados mostraron una disminución del porcentaje de cumplimiento del 8.81%, pero el nivel de cumplimiento de las BPA en ambos años se mantuvo alto.
ABSTRACT In this report, the Level of Compliance with Good Storage Practices in a Medical Device Drugstore, 2020 was evaluated based on the percentage of compliance with the 8 parameters indicated in the Technical Document: Manual of good storage practices for pharmaceutical products, medical devices and sanitary products in Laboratories, Drugstores, Specialized Warehouses and Customs Warehouses, RM N°132-2015 / MINSA. For this, a self-inspection was carried out using the format of the Inspection Act for Drugstores, Specialized Warehouses and Customs Warehouses that store pharmaceutical products, medical devices and sanitary products and the inspection act of the last recertification to compare the results obtained and identify the non-conformities. The results were classified as a high level of compliance with values ≥80%; medium level, for values between 50% to 79%; and low compliance level at values <50%. At the end of the self-inspection, the results were tabulated and a compliance percentage of 89.19% was obtained, considering a high level of compliance, likewise, of the 8 parameters analyzed, only 1, self-inspections, complied 100%, 6 parameters obtained percentages greater than 90% and only 1, complaints and claims, obtained the lowest percentage 75%. When comparing the results of the last recertification, year 2019, and the self-inspection, year 2020, overall, the results showed a decrease in the compliance percentage of 8.81%, but the level of compliance with GAP in both years remained high.
ABSTRACT In this report, the Level of Compliance with Good Storage Practices in a Medical Device Drugstore, 2020 was evaluated based on the percentage of compliance with the 8 parameters indicated in the Technical Document: Manual of good storage practices for pharmaceutical products, medical devices and sanitary products in Laboratories, Drugstores, Specialized Warehouses and Customs Warehouses, RM N°132-2015 / MINSA. For this, a self-inspection was carried out using the format of the Inspection Act for Drugstores, Specialized Warehouses and Customs Warehouses that store pharmaceutical products, medical devices and sanitary products and the inspection act of the last recertification to compare the results obtained and identify the non-conformities. The results were classified as a high level of compliance with values ≥80%; medium level, for values between 50% to 79%; and low compliance level at values <50%. At the end of the self-inspection, the results were tabulated and a compliance percentage of 89.19% was obtained, considering a high level of compliance, likewise, of the 8 parameters analyzed, only 1, self-inspections, complied 100%, 6 parameters obtained percentages greater than 90% and only 1, complaints and claims, obtained the lowest percentage 75%. When comparing the results of the last recertification, year 2019, and the self-inspection, year 2020, overall, the results showed a decrease in the compliance percentage of 8.81%, but the level of compliance with GAP in both years remained high.
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Keywords
nivel de cumplimiento, inspección, porcentaje, almacenamiento, buenas prácticas de almacenamiento