Propuesta de procedimiento operativo estándar para la optimización de la cadena de frío en una Droguería de Trujillo
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Date
2020
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Universidad Nacional de Trujillo
Abstract
El presente informe tuvo como objetivo elaborar un Procedimiento Operativo Estándar para la optimización de la cadena de frio en una Droguería de Trujillo. En la elaboración se realizó un análisis de las siguientes normativas vigentes: Manual de Buenas Prácticas de Almacenamiento según la R.M. N° 132-2015/MINSA; y, Decreto Supremo N° 016-2011- SA Reglamento para el Registro, Control y Vigilancia Sanitaria de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios. Se redactó un Procedimiento Operativo Estándar denominado POE-OCF-001 Optimización de la Cadena de Frio, con la finalidad de describir la forma de cómo llevar a cabo dichos procesos, la frecuencia con la que se debe realizar y las personas responsables; teniendo en cuenta las instalaciones, los equipos y los procedimientos de control y mantenimiento con sus respectivos formatos para las distintas etapas, FOR-OCF-001: Formato registro de emergencias en la cadena de frio; FOR-OCF-002: Formato de control de temperatura de productos refrigerados; FOR-OCF- 003: Formato de verificación de la cadena de frío; y, FOR-OCF-004: Formato de aseguramiento de la cadena de frío. Con el Procedimiento Operativo Estándar se espera reforzar y optimizar el proceso de la cadena de frio en las etapas de recepción, almacenamiento, embalaje y despacho; así como también asegurar que el proceso sea realizado correctamente en base a la normatividad vigente
ABSTRACT The objective of this report was to elaborate a Standard Operating Procedure for the optimization of the cold chain in a Trujillo Drug Store. To prepare the SOP, a review and analysis of the following current regulations was carried out: the new GAP manual according to R.M. N ° 132-2015 / MINSA, Supreme Decree N ° 016-2011-SA Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products; and a Standard Operating Procedure to be implemented called POE-OCF-001 “Optimization of the Cold Chain” was drawn up, in order to describe how to carry out these processes, the frequency with which it must be carried out and the persons responsible; taking into account the facilities, the equipment and the control and maintenance procedures with their respective formats for the different stages, FOR-OCF-001 “Emergency record format in the cold chain”; FOR-OCF-002 "Temperature control format for refrigerated products"; FOR-OCF-003 "Cold chain verification format" and FOR-OCF-004 "Cold chain assurance format". With the Standard Operating Procedure it is expected to reinforce and optimize the cold chain process in the reception, storage, packaging and dispatch stages; as well as ensuring that the process is carried out correctly based on current regulations.
ABSTRACT The objective of this report was to elaborate a Standard Operating Procedure for the optimization of the cold chain in a Trujillo Drug Store. To prepare the SOP, a review and analysis of the following current regulations was carried out: the new GAP manual according to R.M. N ° 132-2015 / MINSA, Supreme Decree N ° 016-2011-SA Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products; and a Standard Operating Procedure to be implemented called POE-OCF-001 “Optimization of the Cold Chain” was drawn up, in order to describe how to carry out these processes, the frequency with which it must be carried out and the persons responsible; taking into account the facilities, the equipment and the control and maintenance procedures with their respective formats for the different stages, FOR-OCF-001 “Emergency record format in the cold chain”; FOR-OCF-002 "Temperature control format for refrigerated products"; FOR-OCF-003 "Cold chain verification format" and FOR-OCF-004 "Cold chain assurance format". With the Standard Operating Procedure it is expected to reinforce and optimize the cold chain process in the reception, storage, packaging and dispatch stages; as well as ensuring that the process is carried out correctly based on current regulations.
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Keywords
Procedimiento Operativo Estándar, cadena de frio, productos refrigerados.