Certificado de Buenas Prácticas de Fabricación: Qué es, sus requisitos y cómo tramitarlo

Buscas como obtener el ¿Certificado de Buenas practicas de Fabricación? acabas de ingresar al portal correcto, sigue leyendo todo lo que tenemos al respecto de esta tema.

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Qué es el Certificado de Buenas Prácticas de Fabricación

El certificado de Buenas Prácticas de Manufactura es aplicable a la producción de fármacos, medicamentos y dispositivos médicos vendidos en el país para verificar si el proceso de producción cumple con los requisitos de las leyes y regulaciones aplicables, garantizando así una salud segura y efectiva.

Qué es el Certificado de Buenas Prácticas de Fabricación

Los consumibles están disponibles. La empresa mencionada por el propietario o representante legal debe ingresar a su proceso de solicitud, incluyendo la información requerida y los correspondientes derechos de pago, y también debe ser notificada por el responsable de higiene, y de acuerdo con la licencia de higiene del producto proporcionada por el fabricante o Notificación de operación.

Requisitos para el Certificado de Buenas Prácticas de Fabricación

  • Formato de autorizaciones, certificados y visitas, debidamente requisitorio ( este debe ser original).
  • Comprobante de pago de derechos, en términos de la Ley Federal de Derechos (debe entregar en original mas dos copias).
  • Aviso de funcionamiento o licencia sanitaria (copia).

Importante:

  • La empresa solicitante debe contar con un documento de certificación válido, el cual se puede encontrar en la página de la COFEPRIS.
  •  Todos los documentos adjuntos a la solicitud deben ser presentados en español, en caso contrario, sus respectivas traducciones al español deben adjuntarse con la firma del gerente de salud. Los documentos emitidos por las autoridades de otros países / regiones deben estar notarizados o legalizados y traducidos por traductores expertos (artículo 153 del Reglamento de Higiene).
  • De acuerdo con el artículo 15 de la Ley Federal de Procedimiento Administrativo, el peticionario deberá adjuntar un documento que acredite su personalidad a su letra y, en su caso, el nombre de la persona con derecho a recibir la notificación. Además de los documentos que acrediten su personalidad jurídica, también puede indicar el número único de certificador registrado (RUPA) del representante legal. De igual forma, el documento debe estar firmado por la parte correspondiente o su representante legal, o para trámites electrónicos, debe estar firmado con una firma electrónica (como una firma).
  • Para jugar RUPA, ingrese a la siguiente liga.
  • Si necesita obtener un nuevo e. Para firmar, ingrese el enlace a continuación link.
  • Si necesita renovar, ingrese el enlace a continuación link.

Cómo tramitar el Certificado de Buenas Prácticas de Fabricación

Este tramite se debe realizar de manera presencial , deben dirigirse a la siguiente dirección Oklahoma No. 14, Nápoles, Benito Juárez, Código Postal 03810, Ciudad de México,Este proceso requiere una cita (a través de Internet o centro de llamadas 01 800 033 50 50).

Cómo tramitar el Certificado de Buenas Prácticas de Fabricación

Para consultas sobre cumplimentación de formularios o requisitos: diríjase al centro de servicio integrado en el área del módulo de información, o llame al call center de COFEPRIS al 01800 033 50 50.

Horario de atención de lunes a viernes:

• Ingrese al programa con cita previa de 8:30 am a 2:00 pm y de 4:00 pm a 6:00 pm.

• Para el módulo de informes, de 8:30 AM a 2:00 PM y de 4:00 PM a 6:00 PM.

• Entregar soluciones del programa sin cita previa: de 8:30 am a 2:00 pm o con cita previa de 4:00 pm a 6:00 pm.

Si se encuentra en el interior de la República, puede ingresar a su programa en el Centros Integrales de Servicios o ventanilla de atención al cliente del Comité Nacional Preventivo de Riesgos en Salud o en la oficina de supervisión de salud de cada entidad. Con base en todo convenio de coordinación que exista entre la entidad federativa y COFEPRIS.

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En el siguiente link aquí. Consulta los Centros Integrales de COFEPRIS

Servicio de mensajería: puede enviar su programa al centro de servicio general de COFEPRIS a través del servicio de mensajería de su elección y adjuntar una guía de mensajería prepaga para enviar una respuesta. El número de teléfono para verificar la entrada de su solicitud y los números de seguimiento es 01 (800) 420-42-24.

Costo: Para cada solicitud de un certificado de respaldo de buenas prácticas de fabricación para productos sanitarios exportados $2,056.58 mxn

Qué es un certificado GPM

Esto significa que los productores se encuentra de acuerdo con » los excelentes estándares de fabricación». En el análisis final, de acuerdo con la normativa vigente, mediante la adopción de principios de calidad integrales, los artículos se pueden fabricar y restringir de manera confiable para garantizar que sus artículos estén protegidos y tengan una buena relación calidad-precio.Qué es un certificado GPM

El propósito de las BPF es asegurar la naturaleza del medicamento y evitar la posibilidad de contaminación. El acuerdo de control de calidad GMP del Centro de Investigación Farmacéutica debe cubrir todo el proceso de montaje. Para obtener la garantía de GMP, el centro de investigación debe demostrar que cuenta con oficinas y equipos adecuados, y seguir estrategias afirmativas para todas las tareas, desde sus requisitos hasta la obtención de materias primas, hasta la creación, agrupación, almacenamiento, transporte y transporte a mayoristas. . O farmacia.

Las regulaciones de GMP son responsables de supervisar áreas, como registros de información, capacidades del personal, higiene, limpieza, inspecciones de hardware, aprobaciones de procesos y cajas de juntas.

El marco de GMP también requiere documentación completa, por lo que cada parte del proceso de incidentes, investigación, creación y coordinación puede identificar y revisar elementos cuando se descubren problemas.

ara ser claros, las organizaciones con certificación GMP pueden garantizar la calidad, seguridad y validez de sus artículos, que son similares a los ejemplos de nuestro laboratorio y los artículos de Ceregumil.

Cuáles son las normas GMP

Estas son las normas principales necesarias para poder cumplir con buenas practicas de fabricación:

Personal

Para realizar los preparativos adecuados, es fundamental la formación de personal bien formado y con experiencia que les permita realizar el control de procesos de acuerdo con el puesto en el que desempeñan sus funciones. Algunas de las reglas más importantes relativas al personal son:

  • Las diferentes tareas realizadas por cada persona involucrada en el proceso de fabricación deben definirse y registrarse en un proceso para evitar lagunas en la aplicación de los estándares de fabricación correctos.
  • Es muy importante para las empresas farmacéuticas establecer planes de saneamiento detallados adecuados para sus instalaciones y procesos de fabricación.
  • La empresa debe formar a sus empleados mediante un programa de formación continua que les permita adaptarse a los nuevos requisitos contenidos en los diferentes procesos de fabricación.
  • El responsable del control de calidad debe ser el responsable específico de esta función, y debe ser independiente de otras personas a cargo de diferentes campos, para que pueda realizar correctamente sus funciones de control de la calidad del producto.
  • Los empleados deben comprender y acatar muchas reglas de la normativa para el manejo de alimentos, productos químicos, etc.
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como llevar ropa adecuada según el proceso, prohibir comer, beber, fumar o masticar en el área de producción, evitar el contacto directo entre manos y productos, lavarse las manos y secar correctamente los sistemas Espere El proceso de buenas prácticas de fabricación también depende del personal, por lo que este es el punto más importante cuando se aplica en una empresa.

Instalaciones y equipos

Los equipos utilizados en la fabricación o procesamiento de productos deben estar certificados y calibrados para asegurar su correcto funcionamiento.

Además, todos esos procesos y procedimientos (incluidos la recepción, el almacenamiento y la distribución) realizados durante el proceso de fabricación deben ser verificados y documentados adecuadamente. Las empresas de fabricación o procesamiento deben tener los recursos y la infraestructura necesarios para producir los productos adecuados.

En cuanto a las instalaciones y lugares donde se elaboran y almacenan los productos, existen algunas normas que promueven la buena implementación del proceso de fabricación, tales como:

  • La instalación debe colocarse en un entorno adecuado de acuerdo con su proceso de fabricación para minimizar el riesgo de contaminación.
  • Las medidas de limpieza y saneamiento deben ser estrictas y regulares para mantenerlos en las condiciones adecuadas de uso.
  • La temperatura de iluminación, ventilación, etc. debe adaptarse a cada proceso para que no afecte negativamente al mismo.
  • El diseño del lugar o instalación utilizada debe evitar la entrada de factores externos (animales, insectos, polvo).
  • El uso correcto del espacio de trabajo debe evitar riesgos como la contaminación cruzada, la confusión entre diferentes procesos y la ejecución incorrecta de procedimientos. Asimismo, se deben señalar las áreas a las que no pueden acceder personas no autorizadas, y las áreas de almacenamiento, producción o control de calidad son áreas comunes a evitar.
  • La conservación de las materias primas, el correcto uso de envases y embalajes deben tomar medidas claras en cuanto a uso, conservación y almacenamiento, porque también son una parte importante del proceso de producción.
  • Es muy importante que el área de producción debe tomar todas las medidas necesarias para una adecuada producción y almacenamiento y seguir una serie de estándares para asegurar buenas prácticas de producción, como limpieza, temperatura adecuada, almacenamiento ordenado, reducción de riesgos, iluminación adecuada, etc. .

Producción, distribución y almacenamiento

El proceso de fabricación debe seguir procedimientos claramente definidos y cumplir con los estándares de fabricación correctos para obtener productos de alta calidad. Para ello, se deben seguir una serie de reglas generales, podemos destacar los siguientes puntos:

  • La producción debe ser realizada y controlada por personal altamente calificado y competente. Todos los procesos relacionados con el procesamiento de productos o materias primas deben seguir estrictamente acuerdos escritos.
  • Los envases y embalajes se manipularán de acuerdo con el contrato y tendrán las etiquetas correspondientes para evitar errores de contenido.
  • Todas las materias primas, productos y embalajes deben almacenarse adecuadamente en condiciones propicias para su conservación.
  • En todos los procesos de fabricación, distribución y almacenamiento, los productos, las materias primas y los envases deben estar marcados para evitar confusiones, y el marcado debe ser permanente para evitar la decoloración o el contenido oscuro.
  • A excepción de aquellos productos registrados en diferentes áreas de producción, no se pueden producir otros productos.
  • Se deben utilizar técnicas y medidas organizativas adecuadas (suficiente sistema de extracción de aire, sistema de producción cerrado, uso de ropa adecuada para el personal, uso de áreas de producción separadas, etc.) para evitar la contaminación cruzada durante la producción.
  • En el proceso de recepción o entrega de materiales o productos se comprobará el estado de los envases y embalajes que los contienen para descartar aquellos que no se encuentren en las condiciones adecuadas. Todas estas inspecciones deben registrarse adecuadamente para controlar la trazabilidad del producto.
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Los procesos de fabricación, distribución y almacenamiento, están regidos por una gran cantidad de normas cuyo objetivo es regular todo el proceso de fabricación, controlando los procedimientos hasta el más mínimo detalle.

Documentación

Para mantener un buen método de fabricación, es importante registrar todos los procesos realizados durante la fabricación. Además, la empresa debe contar con una documentación extensa que detalle cada proceso realizado en este proceso.

  • No solo es suficiente documentar el proceso de planificación de ventas y operaciones, sino que también debe estar escrito en un lenguaje claro e inequívoco, y debe ser particularmente aplicable a los recursos y métodos de producción disponibles de la empresa.
  • Durante el proceso de fabricación, los registros deben escribirse manualmente o mediante equipos electrónicos.
  • Al realizar estos registros en un mismo proceso, se podrá comprobar que todos los procesos y procesos definidos se han realizado de forma eficaz y fiable, y además, la calidad y cantidad de los productos obtenidos están en línea con las expectativas.
  • Se debe registrar cualquier cambio importante y se debe iniciar un proceso de investigación para determinar la causa o razón de los cambios. Los registros que involucren la fabricación y distribución de productos y que permitan la trazabilidad completa de un lote de productos deben mantenerse de manera completa y fácilmente accesible.

Una buena documentación es el componente básico del producto, el aseguramiento de la calidad y la seguridad del sistema, y ​​la clave para cumplir con éxito los requisitos de GMP.

Controles de calidad

El control de calidad debe intervenir en todas las decisiones que afectan la calidad del producto en el proceso de fabricación. Un aspecto mencionado anteriormente y crucial para el éxito del control de calidad es la independencia del control de calidad de la producción:

  • La empresa debe tener un procedimiento claro para retirar cualquier producto, ya sea en la etapa de fabricación, distribución o venta.
  • Las quejas recibidas sobre el producto deben ser estudiadas para poder tomar las medidas oportunas y evitar defectos recurrentes.

El departamento de control de calidad es responsable de verificar que se cumplan los estándares internos de buena preparación de la empresa.

Actividades subcontratadas y Auto inspección

Las empresas que realizan procesos de fabricación establecen relaciones con otras empresas mediante la compra de materiales, procesos de subcontratación o servicios. Por ello, para cumplir con los estándares GMP, es importante que estas empresas también cumplan con las regulaciones que les permitan cumplir con estos estándares para no afectar negativamente la calidad y seguridad de sus productos.

Es necesario implementar un sistema de autoinspección que permita a la empresa verificar que la aplicación de los estándares de fabricación correctos es suficiente, pudiendo también detectar fallas, impulsando así las siguientes propuestas: medidas correctivas.

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  188. When I initially commented I clicked the -Notify me when new comments are added- checkbox and now every time a remark is added I get 4 emails with the same comment. Is there any way you’ll be able to take away me from that service? Thanks!

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  196. Today, I went to the beach front with my children. I found a sea shell and gave it to my 4 year old daughter and said «You can hear the ocean if you put this to your ear.» She placed the shell to her ear and screamed. There was a hermit crab inside and it pinched her ear. She never wants to go back! LoL I know this is entirely off topic but I had to tell someone!

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