{"id":9916,"date":"2024-11-22T14:06:25","date_gmt":"2024-11-22T14:06:25","guid":{"rendered":"https:\/\/amarintech.com\/?p=9916"},"modified":"2024-12-03T14:49:09","modified_gmt":"2024-12-03T14:49:09","slug":"validation-of-computerized-systems","status":"publish","type":"post","link":"https:\/\/amarintech.com\/es\/validation-of-computerized-systems\/","title":{"rendered":"Validaci\u00f3n de Sistemas Computarizados - Gu\u00eda para preparar el Inventario de Sistemas"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"9916\" class=\"elementor elementor-9916\">\n\t\t\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-c78867c elementor-section-height-min-height she-header-yes elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-eae-slider=\"80408\" data-id=\"c78867c\" data-element_type=\"section\" 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class=\"elementor-heading-title elementor-size-default\">Validaci\u00f3n de Sistemas Computarizados - Gu\u00eda para preparar el Inventario de Sistemas<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-32d95f8 elementor-widget elementor-widget-text-editor\" data-id=\"32d95f8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d410b7a elementor-widget elementor-widget-heading\" data-id=\"d410b7a\" data-element_type=\"widget\" data-widget_type=\"heading.default\"><div class=\"elementor-widget-container\"><p class=\"elementor-heading-title elementor-size-default\">Mauro<b> Scasso &#8211; <\/b>Jefe de Aseguramiento de Calidad<\/p><\/div><\/div><div id=\"gtx-trans\" style=\"position: absolute; left: 154px; top: 38px;\"><div class=\"gtx-trans-icon\">\u00a0<\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-62b6c1f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"27064\" data-id=\"62b6c1f\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-97230eb\" data-eae-slider=\"17223\" data-id=\"97230eb\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5a8f378 elementor-widget elementor-widget-text-editor\" data-id=\"5a8f378\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Introducci\u00f3n:<\/strong><\/p><p>En la industria farmac\u00e9utica, la validaci\u00f3n de sistemas computarizados es esencial para garantizar que los sistemas que impactan en el entorno GxP (Good x Practice) cumplan con los est\u00e1ndares de calidad y regulaciones aplicables. Esta pr\u00e1ctica no solo respalda la integridad de los datos, sino que tambi\u00e9n garantiza la seguridad de los pacientes y la eficacia de los productos, aspectos que son responsabilidad directa de cada fabricante.<\/p><p><strong>\u00bfQu\u00e9 es un Sistema Computarizado GxP?<\/strong><\/p><p>Se define como Sistema Computarizado a un sistema que incluye hardware, software, componentes de red, las funciones controladas, el personal involucrado y la documentaci\u00f3n asociada.<\/p><p>Un Sistema Computarizado GxP es un sistema que est\u00e1 sujeto a regulaciones GxP (buenas pr\u00e1cticas de fabricaci\u00f3n, distribuci\u00f3n y otras pr\u00e1cticas aplicables en la industria farmac\u00e9utica y de ciencias de la vida), en otras palabras, se trata de su sistema computarizado que de alguna manera se encuentre involucrado en alguna de estas actividades. Estos sistemas deben cumplir con todos los requisitos regulatorios aplicables y garantizar su idoneidad para el uso previsto. Hablamos de una amplia gama de sistemas, como los de gesti\u00f3n de calidad, sistemas de laboratorio, sistemas de manufactura, sistemas de gesti\u00f3n de datos de ensayos cl\u00ednicos, planificaci\u00f3n de recursos de fabricaci\u00f3n, etc.<\/p><p><strong>Inventario de sistemas computarizados<\/strong><\/p><p>Todos los sistemas computarizados que deberemos validar deber\u00e1n estar listados, es decir incluidos en un inventario.<\/p><p>Un inventario de sistemas es un registro documentado que las empresas reguladas deben mantener, el cual muestra qu\u00e9 sistemas est\u00e1n regulados por GxP. Este inventario proporciona informaci\u00f3n resumida, como el estado de validaci\u00f3n, la propiedad, el impacto, la versi\u00f3n actual y el proveedor para cada sistema. El objetivo es tener un control adecuado sobre los sistemas que apoyan los procesos empresariales, evitando la duplicaci\u00f3n y asegurando que la informaci\u00f3n est\u00e9 a un nivel adecuado, es decir, a nivel de sistemas y no de elementos individuales de hardware.<\/p><p>Un inventario documentado es fundamental para la gesti\u00f3n efectiva de los sistemas, el cumplimiento de regulaciones y la planificaci\u00f3n de su mantenimiento y revisi\u00f3n.<\/p><p>Para la confecci\u00f3n del inventario de sistemas computarizados, es fundamental seguir un proceso ordenado y estructurado que permita registrar y gestionar adecuadamente los sistemas con impacto GxP con su nivel de riesgo asociado. A continuaci\u00f3n, se detallan los pasos que deben seguirse:<\/p><p><strong>1) IDENTIFICACI\u00d3N DE LOS SISTEMAS COMPUTARIZADOS<\/strong><\/p><p>Realizar un mapeo exhaustivo de los procesos empresariales y \u00e1reas de la compa\u00f1\u00eda para identificar todos los sistemas computarizados en uso.<\/p><p><strong>2) EVALUACI\u00d3N DE IMPACTO GXP (PASO A)<\/strong><\/p><p>La evaluaci\u00f3n de impacto GxP consiste en una evaluaci\u00f3n inicial de riesgo que determina el impacto general que el sistema computarizado puede tener en la seguridad del paciente, la calidad del producto y la integridad de los datos.<\/p><p>Para ello, las siguientes preguntas pueden servir como gu\u00eda:<\/p><table><thead><tr><td><p><strong>N\u00b0<\/strong><\/p><\/td><td><p><strong>Preguntas<\/strong><\/p><\/td><\/tr><\/thead><tbody><tr><td><p>1<\/p><\/td><td><p>\u00bfEl Sistema Computarizado (SC) controla o monitorea directa o indirectamente la calidad del Producto?<\/p><\/td><\/tr><tr><td><p>2<\/p><\/td><td><p>\u00bfEl SC afecta el registro del producto, por ej. Drug Master File, Dossier, etc.?<\/p><\/td><\/tr><tr><td><p>3<\/p><\/td><td><p>\u00bfEl SC genera, gestiona, calcula, almacena datos GxP relevantes cubiertos por medio de una regulaci\u00f3n como 21 CFR P11, Anexo 11 EU-GMP, u otra? \u00bfUtiliza firmas electr\u00f3nicas?<\/p><\/td><\/tr><tr><td><p>4<\/p><\/td><td><p>\u00bfEl SC indica los materiales a ser utilizados (por ej. Materias primas, materiales de empaque, productos formulados, materiales de ensayos cl\u00ednicos, etc.?<\/p><\/td><\/tr><tr><td><p>5<\/p><\/td><td><p>\u00bfEs usado para un RECALL, trazabilidad de los stocks o historial del producto?<\/p><\/td><\/tr><tr><td><p>6<\/p><\/td><td><p>\u00bfEl SC mantiene informaci\u00f3n del stock, estado del producto, ubicaci\u00f3n o vida media del mismo?<\/p><\/td><\/tr><tr><td><p>7<\/p><\/td><td><p>\u00bfLos datos provenientes del SC son usados para respaldar la liberaci\u00f3n del producto?<\/p><\/td><\/tr><tr><td><p>8<\/p><\/td><td><p>\u00bfEst\u00e1 relacionado con la conciliaci\u00f3n, el uso parcial de componentes o lotes divididos?<\/p><\/td><\/tr><tr><td><p>9<\/p><\/td><td><p>\u00bfEst\u00e1 relacionado con rotulado, codificado de materiales, producto final o componentes del empaque (por ejemplo r\u00f3tulos de identificaci\u00f3n)?<\/p><\/td><\/tr><tr><td><p>10<\/p><\/td><td><p>\u00bfEl SC afecta o impacta sobre la calidad del producto (pureza, potencia, esterilidad, eficacia)?<\/p><\/td><\/tr><tr><td><p>11<\/p><\/td><td><p>\u00bfEl SC es usado para manejar datos de calificaci\u00f3n del personal que trabaja en producci\u00f3n, dep\u00f3sito (GMP relacionado) o control de calidad?<\/p><\/td><\/tr><tr><td><p>12<\/p><\/td><td><p>\u00bfEl SC supervisa, o controla la distribuci\u00f3n, almacenamiento o transporte de productos o sus condiciones ambientales?<\/p><\/td><\/tr><tr><td><p>13<\/p><\/td><td><p>\u00bfEl SC tiene influencias sobre el mantenimiento y la calibraci\u00f3n del equipamiento (manejo de \u00f3rdenes, certificados, planeamiento de ensayos, l\u00edmites,<\/p><\/td><\/tr><tr><td><p>14<\/p><\/td><td><p>\u00bfEl SC genera, gestiona, almacena documentos tales como S<\/p><\/td><\/tr><\/tbody><\/table><p>Si al menos una respuesta a las preguntas del Punto A es SI el sistema posee impacto GxP. Luego, se determina el nivel de impacto.<\/p><p><strong>Determinaci\u00f3n del Nivel de Impacto GxP<\/strong><\/p><p>Esta evaluaci\u00f3n busca determinar el nivel de impacto de un Sistema GxP, en la cual se tiene en cuenta la complejidad del proceso y la complejidad, novedad y uso del sistema. El nivel de impacto GxP determina la formalidad y el nivel de documentaci\u00f3n necesarios para las etapas subsecuentes.<\/p><p>Para determinar el Nivel de Impacto GxP, se puede emplear la siguiente categorizaci\u00f3n:<\/p><ul><li><strong>High:<\/strong>\u00a0If the system has a direct impact on product quality, patient safety, or data integrity.<br \/>Generally, high-impact systems include those that:<ul><li>Generate, manipulate, or control data supporting regulatory safety and efficacy submissions.<\/li><li>Control critical parameters or data used at any stage, including preclinical, clinical, development, and manufacturing.<\/li><li>Control or provide data for product release.<\/li><li>Control data required for product recalls.<\/li><li>Control records or notifications of adverse events or complaints.<\/li><li>Support pharmacovigilance.<\/li><li><strong>Medium:<\/strong> If the system has a direct impact on regulations but not on product quality, patient safety, or data integrity.<\/li><li><strong>Low:<\/strong>\u00a0If the system has an indirect impact on product quality, patient safety, or data integrity.<\/li><\/ul><\/li><\/ul><p><strong>3) EVALUACI\u00d3N DE LA COMPLEJIDAD DEL SOFTWARE \u2013 CATEGORIZACI\u00d3N GAMP (PASO B)<\/strong><\/p><p>La evaluaci\u00f3n de la complejidad del software, en el contexto de la categorizaci\u00f3n GAMP, se basa en la clasificaci\u00f3n de los componentes de software y hardware, donde se considera que existe un riesgo creciente de fallas o defectos a medida que se avanza de software\/hardware est\u00e1ndar a software\/hardware personalizado.<\/p><p>En general, los productos de software se clasifican en distintas categor\u00edas, siendo las categor\u00edas del 1 al 5, donde:<\/p><p><strong>Categor\u00eda 1: Software de Infraestructura<\/strong><\/p><p>Son elementos que en conjunto conforman un ambiente integrado que permite ejecutar y dar soporte a distintos servicios y sistemas inform\u00e1ticos.<\/p><p>Estos componentes, son:<\/p><ul><li style=\"list-style-type: none;\"><ul><li style=\"list-style-type: none;\"><ul><li>Sistemas Operativos (MS Windows, MacOS, Linux, Unix, etc.).<\/li><li>Motores de Bases de Datos (SQL, Oracle, Posgre, etc.).<\/li><li>Lenguajes de Programaci\u00f3n.<\/li><li>Hojas de c\u00e1lculo y aplicaciones de escritorio (Excel, Word, Outlook etc.).<\/li><li>Antivirus.<\/li><\/ul><\/li><\/ul><\/li><\/ul><p><strong>Categor\u00eda 3: Sistemas no Configurados<\/strong><\/p><ul><li style=\"list-style-type: none;\"><ul><li style=\"list-style-type: none;\"><ul><li>Incluye sistemas comerciales \u201cOff-the-Shelf\u201d (de estanter\u00eda):<\/li><li>Software no configurable.<\/li><li>Software configurable, sin parametrizaci\u00f3n espec\u00edfica (utilizado de forma est\u00e1ndar, por defecto).<\/li><li>Software de c\u00e1lculo estad\u00edstico.<\/li><li>Sistemas de Adquisici\u00f3n de datos no parametrizables.<\/li><\/ul><\/li><\/ul><\/li><\/ul><p>Categor\u00eda 4: Sistemas Configurados<\/p><p>Sistemas que han sido configurados para adecuarse a las necesidades espec\u00edficas del proceso o para contar con interfaces con otros sistemas inform\u00e1ticos<\/p><p><strong>Los Sistemas de la Categor\u00eda 4, incluyen:<\/strong><\/p><ul><li style=\"list-style-type: none;\"><ul><li style=\"list-style-type: none;\"><ul><li>Sistemas est\u00e1ndar, con funcionalidades parametrizables para cubrir los procesos de negocios del \u00e1rea usuaria.<\/li><li>Enlatados configurables.<\/li><li>Sistemas de clase mundial, ampliamente reconocidos en el mercado (LIMS, MES, ERP, etc.).<\/li><li>Un sistema configurable que se categorice como Categor\u00eda 3 por no contar con parametrizaci\u00f3n espec\u00edfica al que, en alg\u00fan momento de su ciclo de vida, se le realice configuraci\u00f3n, deber\u00e1 ser recategorizado como Categor\u00eda 4.<\/li><\/ul><\/li><\/ul><\/li><\/ul><p><strong>Categor\u00eda 5: Sistemas Personalizados<\/strong><\/p><p>Incluye los sistemas personalizados, como as\u00ed tambi\u00e9n aquellos desarrollados a medida del proceso que atender\u00e1n.<\/p><p>La Categor\u00eda 5, incluye:<\/p><ul><li style=\"list-style-type: none;\"><ul><li style=\"list-style-type: none;\"><ul><li>Sistemas est\u00e1ndar, con funcionalidades parametrizables para cubrir los procesos de negocios del \u00e1rea usuaria, y con desarrollos a medida.<\/li><li>Desarrollos de Sistemas internamente<\/li><li>Desarrollos externos o software poco reconocido en la industria (o de otras industrias).<\/li><\/ul><\/li><li>En resumen, la evaluaci\u00f3n de la complejidad del software dentro del marco GAMP implica clasificar el software en una de las categor\u00edas basadas en su uso y caracter\u00edsticas.<\/li><\/ul><\/li><\/ul><p><img decoding=\"async\" class=\"wp-image-9938 aligncenter\" src=\"https:\/\/amarintech.com\/wp-content\/uploads\/2024\/12\/imagen-1-300x182.png\" alt=\"\" width=\"363\" height=\"220\" srcset=\"https:\/\/amarintech.com\/wp-content\/uploads\/2024\/12\/imagen-1-300x182.png 300w, https:\/\/amarintech.com\/wp-content\/uploads\/2024\/12\/imagen-1-768x466.png 768w, https:\/\/amarintech.com\/wp-content\/uploads\/2024\/12\/imagen-1-18x12.png 18w, https:\/\/amarintech.com\/wp-content\/uploads\/2024\/12\/imagen-1.png 861w\" sizes=\"(max-width: 363px) 100vw, 363px\" \/><\/p><p><strong>EVALUACION GENERAL DEL IMPACTO DEL SISTEMA<\/strong><\/p><p>Para realizar la evaluaci\u00f3n total de impacto del sistema se consideran las evaluaciones de impacto GxP Punto A y de complejidad del software en el Punto B y se calcula el nivel de riesgo total del sistema de acuerdo con lo definido en la siguiente matriz de riesg<\/p><ul><li style=\"list-style-type: none;\"><ul><li style=\"list-style-type: none;\"><ul><li class=\"translation-block\">Clase 1: Riesgo Alto<\/li><li><strong>Clase 2: Riesgo Medio<\/strong>\u00a0Medium Risk<\/li><li><strong>Clase 3: Riesgo Bajo<\/strong>\u00a0Low Risk<\/li><\/ul><\/li><\/ul><\/li><\/ul><p><img decoding=\"async\" class=\"size-medium wp-image-9934 aligncenter\" src=\"https:\/\/amarintech.com\/wp-content\/uploads\/2024\/12\/foto-mauro2-300x208.png\" alt=\"\" width=\"300\" height=\"208\" srcset=\"https:\/\/amarintech.com\/wp-content\/uploads\/2024\/12\/foto-mauro2-300x208.png 300w, https:\/\/amarintech.com\/wp-content\/uploads\/2024\/12\/foto-mauro2-18x12.png 18w, https:\/\/amarintech.com\/wp-content\/uploads\/2024\/12\/foto-mauro2.png 560w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p><p><strong>5) DOCUMENTACION Y GESTION DEL INVENTARIO<\/strong><\/p><p>Por \u00faltimo, deberemos integrar la informaci\u00f3n recopilada en un registro formal, empleando herramientas electr\u00f3nicas que permitan una gesti\u00f3n eficiente y actualizaciones peri\u00f3dicas.<\/p><p>Definir un formato estandarizado para el inventario, que incluya secciones para cada uno de los elementos mencionados anteriormente.<\/p><p>Establecer un cronograma para la revisi\u00f3n y actualizaci\u00f3n del inventario de sistemas, asegurando que cualquier cambio en los sistemas o sus atributos se refleje oportunamente.<\/p><p><strong>6) COMUNICACI\u00d3N Y ENTRENAMIENTO<\/strong><\/p><p>Es importante asegurar que el personal involucrado en la gesti\u00f3n de los sistemas est\u00e9 informado sobre la importancia del inventario y los procesos relacionados.<\/p><p>Realizar capacitaciones para garantizar que todos los responsables comprendan c\u00f3mo documentar y mantener actualizado el inventario de manera eficaz.<\/p><p><strong>CONCLUSION<\/strong><\/p><p>Con la informaci\u00f3n obtenida a trav\u00e9s de estos pasos, se confecciona un inventario documentado y completo de los sistemas computarizados a validar. Este inventario es clave para garantizar un control efectivo y el cumplimiento de las regulaciones de GxP, contribuyendo a la transparencia, al control del estado de validaci\u00f3n y a la planificaci\u00f3n estrat\u00e9gica de la gesti\u00f3n de sistemas, facilitando auditor\u00edas y evaluaciones internas<\/p><p>Implementar o revisar el inventario de sistemas computarizados es una pr\u00e1ctica fundamental para asegurar la calidad en la industria farmac\u00e9utica. Aunque el proceso de validaci\u00f3n puede ser riguroso, es esencial una correcta preparaci\u00f3n, gesti\u00f3n y mantenimiento de este documento.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-677db80 elementor-widget elementor-widget-spacer\" data-id=\"677db80\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-5a9c0c8a elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-eae-slider=\"30018\" data-id=\"5a9c0c8a\" data-element_type=\"section\" 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elementor-section-height-default\" data-eae-slider=\"27631\" data-id=\"d24a003\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a1925e7\" data-eae-slider=\"76794\" data-id=\"a1925e7\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-afb4c3b elementor-widget elementor-widget-heading\" data-id=\"afb4c3b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/www.cuervoestudio.com.ar\/\">Copyright \u00a92021 Amarin Technologies \nTodos los derechos reservados - Desarrollo by <u>Cuervo estudio<\/u><\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-3ebecc6\" data-eae-slider=\"73999\" data-id=\"3ebecc6\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>En la industria farmac\u00e9utica, los sistemas computarizados que impactan en entornos GxP deben cumplir con regulaciones estrictas para garantizar la calidad del producto y la seguridad del paciente. Un inventario documentado es esencial para controlar estos sistemas, identificar su impacto GxP y evaluar el nivel de riesgo asociado. Este inventario apoya el cumplimiento normativo, facilita auditor\u00edas y permite la planificaci\u00f3n estrat\u00e9gica de los sistemas, contribuyendo a la transparencia y la integridad de los datos.<\/p>","protected":false},"author":6,"featured_media":9929,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20,22],"tags":[],"class_list":["post-9916","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-challenges","category-technology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Transdermal Patch Manufacturing<\/title>\n<meta name=\"description\" content=\"The production of transdermal patches is a continuous and artisanal process that consists of 3 stages that reflect how delicate and specific is the production of this niche pharmaceutical form. 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