{"id":595,"date":"2019-12-04T10:03:59","date_gmt":"2019-12-04T16:03:59","guid":{"rendered":"https:\/\/grupodesisa.mx\/blog\/?p=595"},"modified":"2021-10-13T14:48:40","modified_gmt":"2021-10-13T19:48:40","slug":"validacion-fase-3-verificacion-continua-de-la-calidad","status":"publish","type":"post","link":"https:\/\/grupodesisa.mx\/blog\/validacion-fase-3-verificacion-continua-de-la-calidad\/","title":{"rendered":"Validaci\u00f3n Etapa 3 Verificaci\u00f3n Continua del Proceso"},"content":{"rendered":"\n<figure class=\"wp-block-image\"><img decoding=\"async\" width=\"626\" height=\"417\" src=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2019\/12\/Reporte-Validacion-Fase-3.jpg\" alt=\"\" class=\"wp-image-604\" srcset=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2019\/12\/Reporte-Validacion-Fase-3.jpg 626w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2019\/12\/Reporte-Validacion-Fase-3-300x200.jpg 300w\" sizes=\"(max-width: 626px) 100vw, 626px\" \/><\/figure>\n\n\n\n<p>La<strong>&nbsp;Validaci\u00f3n Fase III&nbsp;<\/strong>(o etapa 3) refiere a la<strong>&nbsp;Verificaci\u00f3n Continua de la Calidad (VCC)<\/strong>, la cual es una metodolog\u00eda que tiene un enfoque importante para garantizar la calidad del producto en la industria farmac\u00e9utica.&nbsp;<\/p>\n\n\n\n<p>La <strong>NOM-059-SSA1-2015<\/strong> en el punto <strong>9.9.2.3<\/strong> establece las bases para realizar la verificaci\u00f3n continua de los procesos o la llamada verificaci\u00f3n continua de la calidad.<\/p>\n\n\n\n<!--more-->\n\n\n\n<p>Para que la&nbsp;<strong>verificaci\u00f3n del proceso<\/strong>&nbsp;tenga \u00e9xito, las herramientas de evaluaci\u00f3n estad\u00edstica adecuadas son obligatorias, nos permiten&nbsp;<strong>evaluar&nbsp;<\/strong>y&nbsp;<strong>controlar<\/strong>&nbsp;los posibles cambios para evitar que el proceso quede fuera de control y no incurrir en desviaciones.&nbsp;<\/p>\n\n\n\n<p>Una de esas herramientas de apoyo es el nuevo reporte \u201c<strong>Validaci\u00f3n Fase III<\/strong>\u201d incorporado al sistema&nbsp;<strong>RAPSys\u00a9 V2<\/strong>,&nbsp;que adem\u00e1s de sistematizar el proceso de la RAP, le proporciona la estad\u00edstica adecuada para realizar la verificaci\u00f3n continua de la calidad.<\/p>\n\n\n\n<p class=\"text-center\"><a class=\"button button-primary button-circle button-shadow html5lightbox\" href=\"https:\/\/grupodesisa.mx\/descargas\/rapsys-reporte-validacion-fase-3-verificacion-continua-calidad.pdf\">Ver ejemplo del reporte &#8220;Validaci\u00f3n Fase III&#8221;<\/a><\/p>\n\n\n\n<p>Dentro de las caracter\u00edsticas del reporte interesantes, tenemos:<\/p>\n\n\n\n<ul class=\"list-marked wp-block-list\"><li>Gr\u00e1ficas X-R o X-s<\/li><li>C\u00e1lculo de l\u00edmites de control<\/li><li>Histograma de frecuencias<\/li><li>Gr\u00e1fica de probabilidad normal<\/li><li>C\u00e1lculo de Anderson-Darling y valor p<\/li><li>C\u00e1lculos de capacidad de proceso a corto y largo plazo<\/li><li>An\u00e1lisis de tendencias mediante las 8 pruebas<\/li><\/ul>\n\n\n\n<p>En la&nbsp;<strong>VCC<\/strong>&nbsp;se debe&nbsp;<strong>monitorear la calidad<\/strong>&nbsp;del producto de los lotes comerciales despu\u00e9s de completar el dise\u00f1o del proceso y la calificaci\u00f3n del proceso, lo que proporcionar\u00e1 evidencia de que se mantiene un estado de control durante todo el ciclo de vida del producto.<\/p>\n\n\n\n<p>La&nbsp;<strong>validaci\u00f3n del proceso<\/strong>&nbsp;de fabricaci\u00f3n constituye el objetivo final de cualquier pol\u00edtica de validaci\u00f3n, puesto que es el requerimiento GMP fundamental para demostrar el adecuado control del proceso y la capacidad de fabricar de forma reproducible el producto con la calidad establecida.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/grupodesisa.mx\/software-revision-anual-producto\"><img decoding=\"async\" width=\"1024\" height=\"213\" src=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Banner-RAPSys-V2-Horizontal-1024x213.jpg\" alt=\"Reporte validaci\u00f3n fase 3 verificaci\u00f3n continua de la calidad\" class=\"wp-image-294\" srcset=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Banner-RAPSys-V2-Horizontal-1024x213.jpg 1024w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Banner-RAPSys-V2-Horizontal-300x63.jpg 300w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Banner-RAPSys-V2-Horizontal-768x160.jpg 768w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Banner-RAPSys-V2-Horizontal.jpg 1200w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La&nbsp;Validaci\u00f3n Fase III&nbsp;(o etapa 3) refiere a la&nbsp;Verificaci\u00f3n Continua de la Calidad (VCC), la cual es una metodolog\u00eda que tiene un enfoque importante para garantizar la calidad del producto en la industria farmac\u00e9utica.&nbsp; La NOM-059-SSA1-2015 en el punto 9.9.2.3 establece las bases para realizar la verificaci\u00f3n continua de los procesos o la llamada verificaci\u00f3n continua [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":604,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2,40],"tags":[35,49],"class_list":["post-595","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-rapsys","category-verificacion-continua-del-proceso","tag-verificacion-continua-de-la-calidad","tag-verificacion-continua-de-proceso"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6.1 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Validaci\u00f3n Etapa 3 Verificaci\u00f3n Continua del Proceso - Blog Desisa<\/title>\n<meta name=\"robots\" content=\"index, follow, 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