{"id":522,"date":"2022-12-29T17:12:38","date_gmt":"2022-12-29T22:12:38","guid":{"rendered":"https:\/\/proquifar.com\/site\/?page_id=522"},"modified":"2023-07-12T09:03:55","modified_gmt":"2023-07-12T14:03:55","slug":"estabilidad-on-going","status":"publish","type":"page","link":"https:\/\/proquifar.com\/site\/estabilidad-on-going\/","title":{"rendered":"Estabilidad On Going"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"522\" class=\"elementor elementor-522\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c098a32 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"c098a32\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9f23195\" data-id=\"9f23195\" data-element_type=\"column\" data-e-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-c062a5e elementor-align-center elementor-widget elementor-widget-breadcrumbs\" data-id=\"c062a5e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"breadcrumbs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p id=\"breadcrumbs\"><span><span><a href=\"https:\/\/proquifar.com\/site\/\">Home<\/a><\/span><\/span><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7d4a3c9 elementor-widget elementor-widget-heading\" data-id=\"7d4a3c9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Estabilidad On Going<\/h1>\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=\"elementor-section elementor-top-section elementor-element elementor-element-63cee98 elementor-section-full_width elementor-section-content-middle elementor-section-height-default elementor-section-height-default\" data-id=\"63cee98\" data-element_type=\"section\" data-e-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=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-660a15b\" data-id=\"660a15b\" data-element_type=\"column\" data-e-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-bafa418 elementor-widget elementor-widget-image\" data-id=\"bafa418\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"600\" src=\"https:\/\/proquifar.com\/site\/wp-content\/uploads\/2023\/07\/oigon.jpg\" class=\"attachment-full size-full wp-image-1674\" alt=\"\" srcset=\"https:\/\/proquifar.com\/site\/wp-content\/uploads\/2023\/07\/oigon.jpg 800w, https:\/\/proquifar.com\/site\/wp-content\/uploads\/2023\/07\/oigon-300x225.jpg 300w, https:\/\/proquifar.com\/site\/wp-content\/uploads\/2023\/07\/oigon-768x576.jpg 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-f7c1460\" data-id=\"f7c1460\" data-element_type=\"column\" data-e-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-644270b elementor-widget elementor-widget-text-editor\" data-id=\"644270b\" data-element_type=\"widget\" data-e-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>Tras la obtenci\u00f3n de una autorizaci\u00f3n de comercializaci\u00f3n o Registro Sanitario, se debe controlar la estabilidad del producto terminado, de acuerdo con un programa continuo y apropiado, que permita la detecci\u00f3n de cualquier evento de estabilidad asociado con la formulaci\u00f3n, en el sistema de envase y cierre en el que es comercializado, como por ejemplo, cambios en los niveles de impurezas o en el perfil de disoluci\u00f3n.<\/p><p>El prop\u00f3sito del programa de aseguramiento de estabilidad es monitorear el producto durante su vida \u00fatil y determinar que se mantiene y que se puede esperar que permanezca dentro de especificaciones, en las condiciones de almacenamiento indicadas en la etiqueta.<\/p><p>Dentro de este programa tambi\u00e9n se debe considerar la inclusi\u00f3n de productos a granel, por ejemplo, cuando el producto a granel es almacenado durante un largo per\u00edodo antes de ser empacado y\/o transportado desde el lugar de fabricaci\u00f3n a un sitio de envase y el impacto sobre la estabilidad del producto no ha sido previsto en los estudios de estabilidad en la etapa de desarrollo.<\/p>\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=\"elementor-section elementor-top-section elementor-element elementor-element-e4a5f0d elementor-section-full_width elementor-section-content-middle elementor-section-height-default elementor-section-height-default\" data-id=\"e4a5f0d\" data-element_type=\"section\" data-e-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=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-e7f0937\" data-id=\"e7f0937\" data-element_type=\"column\" data-e-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-e386ba6 elementor-widget elementor-widget-text-editor\" data-id=\"e386ba6\" data-element_type=\"widget\" data-e-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>Tambi\u00e9n se pueden aplicar consideraciones similares a productos intermedios que se almacenan y utilizan durante periodos prolongados.<\/p><p>En ciertas situaciones se deben incluir lotes adicionales en el programa, por ejemplo despu\u00e9s de todo cambio significativo o desviaci\u00f3n significativa al proceso de manufactura o al sistema de envase y cierre o toda operaci\u00f3n de reproceso parcial o total de un producto farmac\u00e9utico o de recuperaci\u00f3n de un lote.<\/p><p>El estudio de estabilidad on going debe extenderse hasta el final del per\u00edodo de vida \u00fatil y el n\u00famero de lotes y la frecuencia de los ensayos debe suministrar datos suficientes como para permitir evaluar la tendencia del an\u00e1lisis. A menos que se justifique lo contrario, se debe incluir en el programa de estabilidad un lote por a\u00f1o de producto fabricado, de cada concentraci\u00f3n y de cada tipo de envase primario. Para las situaciones en las que no se produzca durante ese a\u00f1o, se puede aplicar el principio de dise\u00f1o de extremos o el matricial si est\u00e1 cient\u00edficamente recomendado en el protocolo.<\/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-e57dc4e elementor-align-left elementor-widget elementor-widget-button\" data-id=\"e57dc4e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/proquifar.com\/site\/solicitar-servicio\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Solicitar servicio<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-69f9d58\" data-id=\"69f9d58\" data-element_type=\"column\" data-e-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-37ef557 elementor-widget elementor-widget-image\" data-id=\"37ef557\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"383\" height=\"241\" src=\"https:\/\/proquifar.com\/site\/wp-content\/uploads\/2022\/12\/Estabilidad-On-Going-e1672352162738.jpg\" class=\"attachment-full size-full wp-image-377\" alt=\"\" srcset=\"https:\/\/proquifar.com\/site\/wp-content\/uploads\/2022\/12\/Estabilidad-On-Going-e1672352162738.jpg 383w, https:\/\/proquifar.com\/site\/wp-content\/uploads\/2022\/12\/Estabilidad-On-Going-e1672352162738-300x189.jpg 300w\" sizes=\"(max-width: 383px) 100vw, 383px\" \/>\t\t\t\t\t\t\t\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=\"elementor-section elementor-top-section elementor-element elementor-element-4beb749 elementor-section-full_width elementor-section-content-middle elementor-section-height-default elementor-section-height-default\" data-id=\"4beb749\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-3413460\" data-id=\"3413460\" data-element_type=\"column\" data-e-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-abcfb08 elementor-widget elementor-widget-image\" data-id=\"abcfb08\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"423\" height=\"347\" src=\"https:\/\/proquifar.com\/site\/wp-content\/uploads\/2023\/05\/K-Beneficios-e1685038903936.png\" class=\"attachment-large size-large wp-image-1315\" alt=\"\" srcset=\"https:\/\/proquifar.com\/site\/wp-content\/uploads\/2023\/05\/K-Beneficios-e1685038903936.png 423w, https:\/\/proquifar.com\/site\/wp-content\/uploads\/2023\/05\/K-Beneficios-e1685038903936-300x246.png 300w\" sizes=\"(max-width: 423px) 100vw, 423px\" \/>\t\t\t\t\t\t\t\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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-f9226e2\" data-id=\"f9226e2\" data-element_type=\"column\" data-e-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-ca7c918 elementor-widget elementor-widget-heading\" data-id=\"ca7c918\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Beneficios<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4c7e6ce elementor-widget elementor-widget-text-editor\" data-id=\"4c7e6ce\" data-element_type=\"widget\" data-e-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>1.<\/strong> Experiencia de 28 a\u00f1os en la realizaci\u00f3n de Estudios de Estabilidad On Going tomando como gu\u00eda los documentos publicados por INVIMA, OMS e ICH.<\/p><p><strong>2.<\/strong> Aplicaci\u00f3n en diferentes formas farmac\u00e9uticas de dosificaci\u00f3n tales como tabletas, c\u00e1psulas, soluciones y suspensiones orales, polvos orales para reconstituci\u00f3n antes de uso, cremas, ung\u00fcentos, parenterales, \u00f3vulos, y parches.<\/p><p><strong>3.<\/strong> C\u00e1maras climatizadas debidamente calificadas que disponen de registro permanente de las condiciones ambientale especificadas.<\/p><p><strong>4.<\/strong> Confiabilidad en los resultados que emitimos, justificando la credibilidad y posicionamiento que hemos logrado a lo largo de nuestra historia.<\/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-3652dfd elementor-align-left elementor-widget elementor-widget-button\" data-id=\"3652dfd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/proquifar.com\/site\/solicitar-servicio\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Solicitar servicio<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Estabilidad On Going Tras la obtenci\u00f3n de una autorizaci\u00f3n de comercializaci\u00f3n o Registro Sanitario, se debe controlar la estabilidad del producto terminado, de acuerdo con un programa continuo y apropiado, que permita la detecci\u00f3n de cualquier evento de estabilidad asociado con la formulaci\u00f3n, en el sistema de envase y cierre en el que es comercializado, [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_acf_changed":false,"nf_dc_page":"","inline_featured_image":false,"_joinchat":[],"footnotes":""},"class_list":["post-522","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Estabilidad On Going - proquifar<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/proquifar.com\/site\/estabilidad-on-going\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta 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