{"id":69912,"date":"2022-04-27T13:24:59","date_gmt":"2022-04-27T13:24:59","guid":{"rendered":"https:\/\/ainia.endesarrollo.pro\/good-manufacturing-practices-how-to-adapt-my-laboratory-or-workspace-to-gmp-regulations\/"},"modified":"2026-05-26T20:35:04","modified_gmt":"2026-05-26T20:35:04","slug":"good-manufacturing-practices-how-to-adapt-my-laboratory-or-workspace-to-gmp-regulations","status":"publish","type":"post","link":"https:\/\/ainia.endesarrollo.pro\/en\/ainia-news\/good-manufacturing-practices-how-to-adapt-my-laboratory-or-workspace-to-gmp-regulations\/","title":{"rendered":"Good Manufacturing Practices: How can I adapt my laboratory or workspace to GMP regulations?"},"content":{"rendered":"\nLas normas Good Manufacturing Practices (GMP), son la denominaci\u00f3n internacional de las Normas de Correcta Fabricaci\u00f3n. Hoy en d\u00eda se aplican a numerosos sectores productivos como el de la alimentaci\u00f3n, farmacia, cosm\u00e9tica o salud. Todo ello a trav\u00e9s de una serie de normas y directrices que deben seguir los fabricantes. En AINIA estamos implementando la certificaci\u00f3n de productos de acuerdo con las Buenas pr\u00e1cticas de Fabricaci\u00f3n (BPF) ISO 22716:2007. Te lo contamos.\n\nLas normas Good Manufacturing Practices cuyas siglas son GMP, son la denominaci\u00f3n internacional de las Normas de Correcta Fabricaci\u00f3n. En Espa\u00f1a, nos encontramos con dos formas de referirnos a ellas:\n<ul>\n \t<li>BPF: Buenas Pr\u00e1cticas de Fabricaci\u00f3n.<\/li>\n \t<li>NCF: Normas de Correcta Fabricaci\u00f3n<\/li>\n<\/ul>\n<img decoding=\"async\" class=\" wp-image-151159 alignleft\" src=\"https:\/\/ainia.endesarrollo.pro\/wp-content\/uploads\/GMP-sello.png\" alt=\"\" width=\"137\" height=\"169\" \/>\n\nSe aplican, originariamente, a la manufactura de alimentos, f\u00e1rmacos, cosm\u00e9ticos y productos m\u00e9dicos. Aunque, hoy en d\u00eda, su aplicaci\u00f3n se extiende a otros sectores productivos. Todo ello a trav\u00e9s de una serie de normas y directrices que deben seguir los fabricantes.\n\nEl cumplimiento de las GMP es fundamental para la obtenci\u00f3n de un producto inocuo para la salud del consumidor y del propio personal de la empresa.\n<h2><strong>Certificados GMP para el sector de alimentaci\u00f3n: <\/strong><strong>ISO 22000<\/strong><strong>, <\/strong><strong>C\u00f3digo SQF<\/strong><strong>, <\/strong><strong>ISO 9001<\/strong><strong> y <\/strong><strong>APPCC<\/strong><\/h2>\nLos certificados GMP para el sector de alimentaci\u00f3n m\u00e1s importantes son:\n<ul>\n \t<li>La certificaci\u00f3n <a href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:22000:ed-2:v2:es\" target=\"_blank\" rel=\"noopener\">ISO 22000<\/a>, para la inocuidad de los alimentos.<\/li>\n \t<li>C\u00f3digo SQF: Sistema de Gesti\u00f3n en Inocuidad Alimentaria.<\/li>\n \t<li><a href=\"https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:9001:ed-5:v1:es\">ISO 9001<\/a>, para sistemas de <a href=\"https:\/\/sixphere.com\/blog\/control-calidad-produccion\/\">gesti\u00f3n de la calidad<\/a>.<\/li>\n \t<li>An\u00e1lisis de Peligros y Puntos Cr\u00edticos de Control (<a href=\"https:\/\/www.aec.es\/web\/guest\/centro-conocimiento\/appcc\">APPCC<\/a>).<\/li>\n<\/ul>\nLas buenas pr\u00e1cticas de fabricaci\u00f3n (GMP o similar dependiendo del producto final) son esenciales en investigaci\u00f3n, desarrollo y producci\u00f3n de medicamentos. Desde el fabricante al hospital sin importar el tama\u00f1o de la empresa, todos deben cumplir con las regulaciones del GMP.\n\nLas buenas pr\u00e1cticas de fabricaci\u00f3n aportan directrices y gu\u00eda en \u00e1reas como:\n\n1-Gesti\u00f3n de calidad,\n\n2-formaci\u00f3n y cualificaci\u00f3n del personal\n\n3- M\u00e9todo de producci\u00f3n y testeo,\n\n4- Cualificaciones de habitaciones, equipamiento e instalaciones.\n\n5- Validaci\u00f3n de procesos (aseptic process validation)\n\n6- Validaci\u00f3n de m\u00e9todos de testeo\/muestreo (control del ambiente)\n\n7-Validaci\u00f3n de m\u00e9todos de limpieza\n\n8- Validaci\u00f3n de sistemas computarizados.\n\n9-Packaging apropiado (r\u00f3tulos, envases y materiales).\n\n10-Producci\u00f3n, distribuci\u00f3n y almacenamiento adaptados y apropiados.\n\n<img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone wp-image-151163 size-full\" src=\"https:\/\/ainia.endesarrollo.pro\/wp-content\/uploads\/pilares-GMP_ok.png\" alt=\"pilares GMP\" width=\"532\" height=\"465\" \/>\n\nFigura 2. Esquema representativo de los principales pilares del GMP.\n\n&nbsp;\n<h2><strong>\u00bfPor qu\u00e9 son necesarias las buenas pr\u00e1cticas de fabricaci\u00f3n? <\/strong><\/h2>\nPara tener la documentaci\u00f3n, limpieza, y consistencia en la ejecuci\u00f3n del proceso para la obtenci\u00f3n de un producto que no se ve alterado entre producciones, con certificado de calidad y libre de sustancias t\u00f3xicas para el ser humano.\n\nSeg\u00fan la OMS, la mayor\u00eda de las enfermedades (intoxicaciones e, incluso, muertes) transmitidas por alimentos est\u00e1n causadas por bacterias, virus, par\u00e1sitos o contaminantes qu\u00edmicos. Por tanto, la seguridad alimentaria es una preocupaci\u00f3n global.\n\nCuando no se siguen las directrices del GMP, BPF o similar normativa vigente para el laboratorio o las instalaciones, nos podemos encontrar con los siguientes titulares:\n\n<img decoding=\"async\" class=\"alignnone wp-image-151169 \" src=\"https:\/\/ainia.endesarrollo.pro\/wp-content\/uploads\/brasil-1024x158-1.png\" alt=\"\" width=\"551\" height=\"85\" \/>\n\n<em>El ejemplo de los bebes nacidos sin brazos cuando las madres tomaron thalidomide durante el embarazo como medicaci\u00f3n para las n\u00e1useas. <\/em>\n\n<img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-151167 \" src=\"https:\/\/ainia.endesarrollo.pro\/wp-content\/uploads\/sulfanilamide-1024x233-1.png\" alt=\"sulfanilamide\" width=\"559\" height=\"127\" \/>\n\nLas principales causas fueron no seguir la normativa GMP respecto a los siguientes puntos:\n<ul>\n \t<li>Fallos a la hora de seguir procedimientos internos para preparar la documentaci\u00f3n necesaria (master producci\u00f3n)<\/li>\n \t<li>Incumplimiento o fallo al seguir a cabo procedimientos aplicados al control de la prevenci\u00f3n de contaminaci\u00f3n biol\u00f3gica.<\/li>\n \t<li>Error a la hora de observar\/monitorizar a los trabajadores entrando las instalaciones as\u00e9pticas (filling \u00e1reas).<\/li>\n<\/ul>\n&nbsp;\n<h2><strong>\u00bfC\u00f3mo puedo adaptar mi laboratorio o sala de trabajo con la normativa BPF?<\/strong><\/h2>\nEn AINIA estamos comprometidos con nuestros clientes y los sistemas de calidad vigentes. Es por eso que, en la planta piloto de biotecnolog\u00eda, estamos implementando la certificaci\u00f3n de productos de acuerdo con las <strong>Buenas pr\u00e1cticas de Fabricaci\u00f3n (BPF) ISO 22716:2007.<\/strong>\n<ul>\n \t<li><strong>Leer la gu\u00eda BPF:<\/strong> Como paso inicial, se ha de leer la gu\u00eda de las buenas pr\u00e1cticas de fabricaci\u00f3n (BPF).<\/li>\n \t<li><strong>Realizar una autoinspecci\u00f3n:<\/strong> El siguiente paso es realizar una autoinspecci\u00f3n en la cual se ha de aplicar el pensamiento cr\u00edtico y la audacia de un inspector que visita las instalaciones por primera vez.<\/li>\n \t<li><strong>Identificar puntos de mejora y redactar un plan de trabajo:<\/strong> En AINIA se han identificado puntos de mejora a la hora de gestionar el laboratorio y se ha redactado un plan de trabajo correspondiente a las necesidades b\u00e1sicas de las instalaciones.<\/li>\n<\/ul>\n-Documentaci\u00f3n a actualizar\n\n-Equipos necesarios y su correcto etiquetado\n\n-Curr\u00edculos de formaci\u00f3n y cualificaci\u00f3n para tareas especificas\n\n-Auditor\u00edas internas y externas\n\n&#8211; Materias primas y productos\n\n-Control y monitoreo de las instalaciones\n\n-Gesti\u00f3n de residuos\n\n-Desviaciones y no conformidades.\n\nC\u00f3mo se puede observar hay un elemento que siempre es recurrente:\n\n<strong><em>Si no est\u00e1 documentado, no ha pasado<\/em><\/strong>\n\nEsta regla de oro nos lleva a uno de los pilares mas importantes de la calidad en laboratorios e instalaciones: la integridad de los datos.\n<ul>\n \t<li><strong>Comprobar la integridad de los datos<\/strong>: Para saber si nuestro sistema actual cumple con los requisitos de la de integridad de datos nos hemos de preguntar si cumple con la siguiente definici\u00f3n:\n<ul>\n \t<li>Atribuible: Se identifica inequ\u00edvocamente al autor. Quien y cuando.<\/li>\n \t<li>Legible: Cualquier persona puede leer el contenido.<\/li>\n \t<li>Contempor\u00e1neo: la informaci\u00f3n est\u00e1 registrada en el momento en el que ocurre.<\/li>\n \t<li>Original: la informaci\u00f3n est\u00e1 registrada en un documento oficial o en copias exactas y certificadas de un documento original.<\/li>\n \t<li>Accurate (preciso): Datos correctos, revisiones hechas de forma independiente.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<strong>Implementar los cambios y comenzar a trabajar: <\/strong>El \u00faltimo paso ser\u00eda implementar los cambios en el laboratorio y comenzar a trabajar respecto a las directrices mencionadas en las Buenas pr\u00e1cticas de Fabricaci\u00f3n (BPF) ISO 22716:2007.\n<h3>GMPs para la producci\u00f3n industrial de principios activos para alimentaci\u00f3n y farmacia<\/h3>\nEn Altex (planta industrial de alta tecnolog\u00eda extractiva de AINIA) tenemos implantado un sistema de producci\u00f3n basado en las buenas pr\u00e1cticas de fabricaci\u00f3n GMP (Good Manufacturing Practice). Estas normas, implantadas desde 2013, nos han permitido potenciar nuestra presencia en el mercado de fabricantes de principios activos (m\u00e1s conocidos como APIs -Active Pharmaceutical Ingredients-), tanto aquellos orientados a la incorporaci\u00f3n a medicamentos, como a cosm\u00e9ticos o alimentos.\n\nSi te interesa saber m\u00e1s sobre el proceso, no dudes en ponerte en contacto con nosotros, Porque la calidad somos todos y es parte de nuestros productos y clientes.\n\n<img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-144362\" src=\"https:\/\/ainia.endesarrollo.pro\/wp-content\/uploads\/IvaceDeclaracion-cs-3-300x146.png\" alt=\"Ivace-promece-mayo-2019\" width=\"300\" height=\"146\" \/>\n\n<script src=\"moz-extension:\/\/7f919efc-b420-45c4-a864-26c2dec26a32\/inject-scripts\/searchvideos.js\" async=\"\"><\/script>\n","protected":false},"excerpt":{"rendered":"<p>Las normas Good Manufacturing Practices (GMP), son la denominaci\u00f3n internacional de las Normas de Correcta Fabricaci\u00f3n. Hoy en d\u00eda se aplican a numerosos sectores productivos como el de la alimentaci\u00f3n, farmacia, cosm\u00e9tica o salud. Todo ello a trav\u00e9s de una serie de normas y directrices que deben seguir los fabricantes. En AINIA estamos implementando la [&hellip;]<\/p>\n","protected":false},"author":457,"featured_media":69913,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[79,87],"tags":[],"tipo-documento":[],"class_list":["post-69912","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ainia-news","category-technological-innovation"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Good Manufacturing Practices (GMP): how to adapt your lab to regulation<\/title>\n<meta name=\"description\" content=\"Good practices manufacturing (GMP): key principles, documentation, validation and audits to adapt your lab\/workspace to GMP regulations (ISO 22716:2007).\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, 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