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    los aspectos que deben cuidarse en las condiciones de almacenamiento de medicamentos y demás insumos para la salud son

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    obtenga los aspectos que deben cuidarse en las condiciones de almacenamiento de medicamentos y demás insumos para la salud son de este sitio.

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    Respuesta: La etiqueta de cada unidad (bote, frasco, etc.) debe indicar de forma legible:– el nombre del producto en DCI,– la forma y dosificación,– el número d…

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    fuente : brainly.lat

    Estándares para la conservación de productos farmacéuticos.

    Los medicamentos y otros insumos para la salud requieren condiciones de conservación especiales que permitan mantener a lo largo de su vida útil, su calidad. Aunque en términos generales los productos farmacéuticos requieren estar en un lugar seco, sin luz directa del sol y a temperatura ambiente (no mayor a 30°C); existen otros que, por …

    Estándares para la conservación de productos farmacéuticos.

    Jun 26, 2019 | Regulación sanitaria

    Los medicamentos y otros insumos para la salud requieren condiciones de conservación especiales que permitan mantener a lo largo de su vida útil, su calidad.

    Aunque en términos generales los productos farmacéuticos requieren estar en un lugar seco, sin luz directa del sol y a temperatura ambiente (no mayor a 30°C); existen otros que, por sus propiedades físicas, químicas y/o terapéuticas, necesitan condiciones particulares.

    “Las condiciones de almacenamiento deberán conservarse de acuerdo a las recomendaciones del fabricante, las cuales están definidas con base a los resultados de los estudios de estabilidad realizados conforme a la norma oficial mexicana vigente que corresponda” (NOM-073-SSA1-2015, Estabilidad de fármacos y medicamentos, así como de remedios herbolarios): Farmacopea de los Estados Unidos Mexicanos, undécima edición, generalidades, página 17.

    La determinación de las condiciones de conservación de cada uno de los medicamentos y demás insumos para la salud es proveída por los fabricantes, con base en los resultados de su análisis farmacéutico y de los estudios de estabilidad que realizan desde antes de la fase pre-clínica para medicamentos nuevos, autorizados por la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), al momento de solicitar el registro sanitario.

    La “estabilidad” es la capacidad de un fármaco, medicamento o remedio herbolario para mantener, durante el tiempo de almacenamiento y uso, sus especificaciones de calidad.

    Los “Estudios de estabilidad” son las pruebas que se realizan a un fármaco, medicamento o remedio herbolario, por un tiempo determinado, bajo la influencia de temperatura, humedad o luz en el envase que lo contiene, para demostrar el periodo de vida útil y determinar su fecha de caducidad.

    Existen dos tipos, los de “estabilidad acelerada” y los de “estabilidad a largo plazo”. Los primeros, se realizan en condiciones extremas de almacenamiento para incrementar la velocidad de degradación química, biológica o los cambios físicos; mientras que los segundos, se aplican para comprobar las condiciones de almacenaje y de vida de anaquel, a través de un programa de tiempos de muestreo y de evaluación de los requisitos físicos, químicos, biológicos, que comprueban la conservación de sus propiedades durante su periodo de vida útil.

    (NOM-073-SSA1-2015, Estabilidad de fármacos y medicamentos, así como de remedios herbolarios)

    Una vez que se definen y autorizan las condiciones de almacenamiento y caducidad del producto, corresponde a cada agente de la cadena de suministro, cumplir con las condiciones establecidas en el marbete del producto, a fin de garantizar la seguridad, la eficacia y la calidad de dichos productos.

    Dichas condiciones se establecen, en la norma oficial mexicana NOM-059-SSA1-2015, buenas prácticas de fabricación de medicamentos, la cual es de observancia obligatoria para todos los establecimientos dedicados a la fabricación e importación de medicamentos, los laboratorios de control de calidad, almacenes de acondicionamiento, depósito y distribución de medicamentos y materias primas para su elaboración.

    Un rubro particularmente importante, es el que se hace responsable de mantener las condiciones de refrigeración constante o de cadena fría, de la que dependen procesos de conservación que exigen máxima atención, como los necesarios para preservar las vacunas, las que desde su producción y hasta su aplicación, deben mantener su capacidad para provocar una adecuada respuesta inmunogénica. 

    La Cadena de frío, es el proceso logístico de almacenamiento, conservación, manejo y distribución de los medicamentos, cuya finalidad es la de asegurar que los productos se conserven en todo momento dentro de los rangos de temperatura establecidos, para que no pierdan su poder curativo o preventivo.

    Niveles de la cadena de frío:

    La cadena de frío está conformada por tres niveles básicos.

    CENTRAL: Es el primer eslabón de la cadena y debe poseer cámaras de congelación y cámaras frías para almacenar las vacunas por el período de vida útil que señale el fabricante.REGIONAL: El segundo eslabón de la cadena debe poseer cámaras frías donde conservar los medicamentos durante 3 meses.LOCAL: El tercer eslabón de la cadena de frío debe poseer refrigeradores que permitan conservarlos por un 1 mes.

    Los tres niveles se encuentran relacionados entre sí por una red de transporte especializado, a través de la que circulan los medicamentos hasta su destino final.

    Además, en todos y cada uno de los niveles se realiza controles estrictos de temperatura, en el momento del transporte y en el almacenamiento como lo dicta la norma oficial mexicana NOM-059-SSA1-2015, buenas prácticas de fabricación de medicamentos.

    Dentro de la cadena de suministro, la distribución es una de las actividades más importantes, pues además de garantizar la preservación de la calidad, debe prevenir que medicamentos falsificados ingresen en ella, asegurando el control de los procedimientos de distribución, a fin de mantener la calidad e integridad de los fármacos.

    fuente : codigof.mx

    Guía para Almacenes de Depósito y Distribución de Medicamentos y demás insumos para la salud

    El presente documento tiene el propósito de informar a los establecimientos que almacenan y distribuyen medicamentos y demás insumos para...

    Guía para Almacenes de Depósito y Distribución de Medicamentos y demás insumos para la salud

    Guía para Almacenes de Depósito y Distribución de Medicamentos y demás insumos para la salud El presente documento tiene el propósito de informar a los establecimientos que almacenan y distribuyen medicamentos y demás insumos para la salud, las condiciones sanitarias que deben prevalecer para cumplir con la normatividad vigente.

    Comisión Federal para la Protección contra Riesgos Sanitarios | 01 de noviembre de 2017

    Uno de los principales objetivos de la Guía de buenas prácticas para establecimientos que almacenan y distribuyen medicamentos y demás insumos para la salud, consiste en informar los elementos que se deben evaluar para mantener las condiciones sanitarias de los mismos. De igual forma, tiene el propósito de brindar información sobre los aspectos técnicos para que los responsables de este tipo de negocios puedan identificar de manera ágil y sencilla aquellos puntos de mejora para darles oportuna atención y cumplir de manera eficiente con las disposiciones sanitarias incluídas en la normatividad vigente.

    Paginas : de Cargando...

    fuente : www.gob.mx

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