Implementación de un proceso para el control de material de empaque secundario en un laboratorio Farmacéutico Nacional
No Thumbnail Available
Date
2021
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Universidad Nacional de Trujillo
Abstract
Dado el inicio de las prácticas pre-profesionales en un Laboratorio Farmacéutico Nacional, se observó un gran vacío en el control de ingreso de material de empaque secundario (cajas y etiquetas) que evidenciaba grandes pérdidas por causa de defectos de éstos. Tales pérdidas surgieron por falta de un plan de muestreo significativo, y por documentación inexistente. El objetivo del presente informe fue generar un proceso de control de muestreo y análisis de material de empaque secundario (cajas y etiquetas) para los productos farmacéuticos que produce y comercializa un Laboratorio Farmacéutico Nacional, que va de la mano de la elaboración y actualización de especificaciones técnicas de los mismos. La metodología de trabajo utilizada se resume en la búsqueda de información y revisión de las mismas, de acuerdo a la disponibilidad de éstas. Una vez obtenido lo necesario se evaluó su utilidad, obteniendo ineficiencia documentaria. Por ello, se planteó un proceso de control que sea eficiente para la inspección de material de empaque secundario. Una vez elaborados los documentos, se sometían a revisión, aprobación y posterior implementación de cada documento elaborado. La estructura de los documentos elaborados se ajusta a la definida por el laboratorio. Los resultados obtenidos fueron la elaboración de especificaciones técnicas, y un flujograma para el control de muestreo y análisis de material de empaque secundario (cajas y etiquetas), además de una tabla de defectos según tipo de criticidad. Finalmente, con la implementación del proceso se facilitó obtener un control para la verificación de cantidades que deben muestrearse para decidir si aceptar o rechazar algún material de empaque secundario.
ABSTRACT Given the beginning of the pre-professional practices in a National Pharmaceutical Laboratory, there is a great gap in the control of entry of secondary packaging material (boxes and labels) that evidenced large losses due to shipping defects. Such losses arose from the lack of a meaningful sampling plan, and from non-existent documentation. The objective of this report was to generate a control process for the sampling and analysis of secondary packaging material (boxes and labels) for pharmaceutical products produced and sold by a National Pharmaceutical Laboratory, that went hand in hand with the development and updating of technical specifications of the same. The work methodology used is summarized in the search for information and its review, according to their availability. Once what was necessary was obtained, its usefulness was evaluated, obtaining documentary inefficiency. Therefore, an efficient control process was proposed for the inspection of secondary packaging material. Once the documents have been prepared, they are submitted to review, approval and subsequent implementation of each document prepared. The structure of the documents produced is in accordance with that defined by the laboratory. The results obtained were the elaboration of technical specifications, and a flow chart for the control of sampling and analysis of secondary packaging material (boxes and labels), as well as a table of defects according to the type of criticality. Finally, with the implementation of the process, it was facilitated to obtain a control for the verification of quantities that must be sampled to decide whether to accept or reject any secondary packaging material (boxes and labels).
ABSTRACT Given the beginning of the pre-professional practices in a National Pharmaceutical Laboratory, there is a great gap in the control of entry of secondary packaging material (boxes and labels) that evidenced large losses due to shipping defects. Such losses arose from the lack of a meaningful sampling plan, and from non-existent documentation. The objective of this report was to generate a control process for the sampling and analysis of secondary packaging material (boxes and labels) for pharmaceutical products produced and sold by a National Pharmaceutical Laboratory, that went hand in hand with the development and updating of technical specifications of the same. The work methodology used is summarized in the search for information and its review, according to their availability. Once what was necessary was obtained, its usefulness was evaluated, obtaining documentary inefficiency. Therefore, an efficient control process was proposed for the inspection of secondary packaging material. Once the documents have been prepared, they are submitted to review, approval and subsequent implementation of each document prepared. The structure of the documents produced is in accordance with that defined by the laboratory. The results obtained were the elaboration of technical specifications, and a flow chart for the control of sampling and analysis of secondary packaging material (boxes and labels), as well as a table of defects according to the type of criticality. Finally, with the implementation of the process, it was facilitated to obtain a control for the verification of quantities that must be sampled to decide whether to accept or reject any secondary packaging material (boxes and labels).
Description
Keywords
Control de calidad