Nivel de cumplimiento de las Buenas Prácticas de Almacenamiento en un establecimiento farmacéutico de Trujillo, mayo 2021 – mayo 2022
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Date
2022
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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 un establecimiento farmacéutico privado de Trujillo en el periodo mayo 2021 – mayo 2022. Se recolectaron datos de inspección del periodo correspondiente sobre los 8 factores 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. Se clasificaron considerando la siguiente escala porcentual: muy alto, igual o mayor a 95%; alto, valores comprometidos entre 80% y 95%; medio, valores entre los 50% y 80% y bajo a los valores que se encuentran igual o por debajo del 50%. El porcentaje promedio del nivel de cumplimiento del establecimiento farmacéutico fue de 92,38%, considerando este óptimo. El factor que más deficiencia tuvo fue sistema de aseguramiento de la calidad con un valor del 72,0 %, por tal razón su nivel de cumplimiento fue medio. Los factores que más prevalecieron son: reclamos, retiro del mercado y auto inspecciones, quienes cumplieron al 100,0 % con todos los parámetros establecidos.
ABSTRACT In this report, the Level of compliance with Good Storage Practices was evaluated in a private pharmaceutical establishment in Trujillo in the period May 2021 – May 2022. Inspection data was collected for the corresponding period on the 8 factors indicated in the Technical Document: Manual of good storage practices for pharmaceutical products, medical devices and health products in Laboratories, Drugstores, Specialized Warehouses and Customs Warehouses, RM No. 132-2015/MINSA. They were classified considering the following percentage scale: very high, equal to or greater than 95%; high, compromised values between 80% and 95%; medium, values between 50% and 80% and low to values that are equal to or below 50%.The average percentage of the level of compliance of the pharmaceutical establishment was 92,38%, considering this optimal. The factor that had the most deficiency was the quality assurance system with a value of 72,o%, for this reason its level of compliance was medium. The factors that prevailed the most are: claims, withdrawal from the market and self-inspections, who complied 100,0 % with all the established parameters.
ABSTRACT In this report, the Level of compliance with Good Storage Practices was evaluated in a private pharmaceutical establishment in Trujillo in the period May 2021 – May 2022. Inspection data was collected for the corresponding period on the 8 factors indicated in the Technical Document: Manual of good storage practices for pharmaceutical products, medical devices and health products in Laboratories, Drugstores, Specialized Warehouses and Customs Warehouses, RM No. 132-2015/MINSA. They were classified considering the following percentage scale: very high, equal to or greater than 95%; high, compromised values between 80% and 95%; medium, values between 50% and 80% and low to values that are equal to or below 50%.The average percentage of the level of compliance of the pharmaceutical establishment was 92,38%, considering this optimal. The factor that had the most deficiency was the quality assurance system with a value of 72,o%, for this reason its level of compliance was medium. The factors that prevailed the most are: claims, withdrawal from the market and self-inspections, who complied 100,0 % with all the established parameters.
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Keywords
Buenas Prácticas de Almacenamiento, Establecimiento farmacéutico.