Actualización y creación de listas de verificación para auditorías Droguería Ñuñoa
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Archivos
Fecha
2022
Profesor/a Guía
Facultad/escuela
Idioma
es
Título de la revista
ISSN de la revista
Título del volumen
Editor
Universidad Andrés Bello
Nombre de Curso
Licencia CC
Licencia CC
Resumen
La normativa técnica N° 147 del Ministerio de Salud de Chile establece una serie de
requerimientos los cuales deben ser cumplidos por droguerías y depósitos de
productos farmacéuticos entre otros. Dentro de los requerimientos que aborda,
exige que los sistemas de gestión de estos establecimientos incluyan
autoinspecciones y/o auditorias, con la finalidad de evaluar la efectividad y
aplicabilidad de sus sistemas de gestión de calidad sobre las buenas prácticas de
almacenamiento y distribución.
En base a este requerimiento se desarrollaron listas de verificación para auditorias
basándose en la recolección y análisis de la documentación vigente relacionada a
diversos procedimientos operativos estándares de Drogueria Ñuñoa, relacionados
a la Norma técnica N° 147 de buenas prácticas de almacenamiento y distribución
junto con la Norma técnica N° 208 de “almacenamiento y transporte de
medicamentos refrigerados y congelados”, generando un diagnóstico en relación
con la concordancia y cumplimiento de la documentación interna analizada respecto
a los requerimientos normativos.
Se realizó un análisis de toda la documentación relacionada a los procesos de
operaciones logísticas de la organización. También se desarrolló una
caracterización de los requerimientos de la normativa segregando estos en un
sistema de criticidad basado en los criterios de la autoridad sanitaria ANAMED.
Obteniendo como resultado final un total de 19 listas de verificación para auditorias.
En conclusión, las listas de verificación para auditorias creadas son una herramienta
de calidad y de utilidad para evaluar cómo son ejecutados los procedimientos
operativos de la organización, además de permitir medir el nivel de cumplimiento de
los requerimientos exigidos por el marco normativo de manera objetiva y sencilla,
mediante la aplicación de tablas de porcentajes de cumplimiento, segregadas según
criticidad de cada requerimiento, determinando cuales de estos necesitan ser
evaluados con prioridad en los planes de acciones correctivas y preventivas
posterior a las auditorias.
Technical regulation No. 147 of the Chilean Ministry of Health establishes a series of requirements which must be met by drugstores and pharmaceutical product warehouses, among others. Within the requirements it addresses, it requires that the management systems of these establishments must include self-inspections and/or audits, in order to assess the effectiveness and applicability of their quality management systems on good storage and distribution practices. Based on these requirements, the audit lists were developed based on the collection and analysis of current documentation related to various standard operating procedures of Drogueria Ñuñoa, related to Technical Standard No. 147 of good storage and distribution practices together with the Technical standard No. 208 on "storage and transport of refrigerated and frozen medicines", generating a diagnosis in relation to the consistency and compliance of the internal documentation analyzed regarding the regulatory requirements. An analysis of all the documentation related to the logistics operations processes of the organization, among others, was carried out. A characterization of the regulatory requirements was also carried out, segregating these into a criticality system based on the criteria of the ANAMED health authority. Obtaining as a final result a total of 19 checklists for audits. In conclusion, the checklists for audits created are a useful quality tool to evaluate how the organization's operating procedures are carried out, in addition to allowing the level of compliance with the requirements demanded by the regulatory framework to be measured objectively and easily. through the application of compliance percentage tables, segregated according to the criticality of each requirement, determining which requirements need to be evaluated with priority in the corrective and preventive action plans after the audits.
Technical regulation No. 147 of the Chilean Ministry of Health establishes a series of requirements which must be met by drugstores and pharmaceutical product warehouses, among others. Within the requirements it addresses, it requires that the management systems of these establishments must include self-inspections and/or audits, in order to assess the effectiveness and applicability of their quality management systems on good storage and distribution practices. Based on these requirements, the audit lists were developed based on the collection and analysis of current documentation related to various standard operating procedures of Drogueria Ñuñoa, related to Technical Standard No. 147 of good storage and distribution practices together with the Technical standard No. 208 on "storage and transport of refrigerated and frozen medicines", generating a diagnosis in relation to the consistency and compliance of the internal documentation analyzed regarding the regulatory requirements. An analysis of all the documentation related to the logistics operations processes of the organization, among others, was carried out. A characterization of the regulatory requirements was also carried out, segregating these into a criticality system based on the criteria of the ANAMED health authority. Obtaining as a final result a total of 19 checklists for audits. In conclusion, the checklists for audits created are a useful quality tool to evaluate how the organization's operating procedures are carried out, in addition to allowing the level of compliance with the requirements demanded by the regulatory framework to be measured objectively and easily. through the application of compliance percentage tables, segregated according to the criticality of each requirement, determining which requirements need to be evaluated with priority in the corrective and preventive action plans after the audits.
Notas
Seminario (Químico Farmacéutico)
Palabras clave
Auditoría, Farmacias, Normas, Control de Calidad, Chile, Ñuñoa