Implementación y certificación de las Buenas Prácticas de Distribución y Transporte según la normativa nacional R.M. N° 833-2015/MINSA en una droguería encargada de la importación, comercialización y distribución de productos farmacéuticos a temperatura ambiente

• Autor: Alarcón Benavides, Rocio de la Aurora
• Formato: tesis de grado
• Fecha de Publicación: 2021
• Institución: Universidad Peruana Cayetano Heredia
• Repositorio: UPCH-Institucional
• Lenguaje: español
• OAI Identifier: oai:repositorio.upch.edu.pe:20.500.12866/9018
• Enlace del recurso: https://hdl.handle.net/20.500.12866/9018
• Nivel de acceso: acceso abierto
• Materia: Buenas Prácticas de Distribución y Transporte; Procedimientos Operativos Estándares; Manual de Calidad y Funciones; Temperatura ambiente; http://purl.org/pe-repo/ocde/ford#3.01.05; http://purl.org/pe-repo/ocde/ford#3.01.06; http://purl.org/pe-repo/ocde/ford#3.03.02

The General Directorate of Medicines, Supplies and Drugs (DIGEMID), issued by R.M. N ° 833-2015/MINSA the “Manual of Good Practices for Distribution and Transport of Pharmaceutical Products, Medical Devices and Health Products”; The framework of these document is focused on the fulfillment of mandatory minimum standards that must be met to guarantee the maintenance of the quality and integrity of pharmaceutical products. The certification is granted by the Regional Health Directorates (DIRESA), which in our case corresponds to DIRESA-CALLAO. In this work of professional sufficiency, as a first step, a diagnosis of the company in question was carried out according to a detailed analysis and in accordance with the requirements of the R.M. N ° 833-2015 / MINSA; after that, the proposal for the implementation of the improvement actions and technical documents to obtain the certification was proposed. In order to demonstrate how, after the execution and compliance with these guidelines, an improvement was made to the processes related to the distribution and transportation of pharmaceutical products, preserving their quality, safety and efficacy. The achievement of all these objectives helps to achieve the satisfaction of our clients or end users (patients). In order to obtain the approach and implementation of the aforementioned, it is necessary to put into practice all the knowledge, skills, as well as demonstrate the aptitudes, competencies and research spirit acquired during my university training.