{"id":2981,"date":"2026-06-02T21:51:36","date_gmt":"2026-06-02T21:51:36","guid":{"rendered":"https:\/\/assig.com.mx\/?page_id=2981"},"modified":"2026-06-02T21:55:07","modified_gmt":"2026-06-02T21:55:07","slug":"blog-nom-059-ssa1-2015-la-base-de-las-buenas-practicas-de-fabricacion-en-la-industria-farmaceutica","status":"publish","type":"page","link":"https:\/\/assig.com.mx\/?page_id=2981","title":{"rendered":"Blog NOM-059-SSA1-2015: la base de las Buenas Pr\u00e1cticas de Fabricaci\u00f3n en la industria farmac\u00e9utica"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"2981\" class=\"elementor elementor-2981\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-38e6989f elementor-section-full_width elementor-section-content-middle elementor-section-height-default elementor-section-height-default\" data-id=\"38e6989f\" data-element_type=\"section\" data-e-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=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-4cdb343\" data-id=\"4cdb343\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-95090a7 elementor-widget elementor-widget-heading\" data-id=\"95090a7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">NOM-059-SSA1-2015: la base de las Buenas Pr\u00e1cticas de Fabricaci\u00f3n en la industria farmac\u00e9utica<\/h4>\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-299aba36\" data-id=\"299aba36\" 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-67f437ad elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"67f437ad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400;\"><span style=\"color: #000000;\">La calidad de un medicamento no puede comprobarse \u00fanicamente mediante an\u00e1lisis finales. Debe construirse desde el dise\u00f1o de las instalaciones, la capacitaci\u00f3n del personal, los procesos de fabricaci\u00f3n y los controles de calidad.<\/span><\/p><p style=\"font-weight: 400;\"><span style=\"color: #000000;\">Por ello, la\u00a0<span style=\"color: #33cccc;\"><strong>NOM-059-SSA1-2015<\/strong><\/span>\u00a0establece los requisitos de\u00a0<span style=\"color: #33cccc;\"><strong>Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF)<\/strong><\/span>\u00a0que deben cumplir los establecimientos dedicados a la fabricaci\u00f3n de medicamentos para uso humano. Su objetivo es garantizar que los productos sean elaborados de forma consistente, segura y conforme a las especificaciones establecidas.\u00a0<\/span><\/p><p><span style=\"font-weight: 400; color: #000000;\">En\u00a0<span style=\"color: #33cccc;\"><strong>ASSIG<\/strong><\/span>, apoyamos a laboratorios farmac\u00e9uticos, fabricantes de dispositivos m\u00e9dicos y empresas del sector salud en la implementaci\u00f3n y fortalecimiento de sistemas de calidad alineados con los requisitos regulatorios de COFEPRIS.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7edeb1c elementor-widget elementor-widget-heading\" data-id=\"7edeb1c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">\u00bfQu\u00e9 es la NOM-059-SSA1-2015?\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b889162 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"b889162\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400;\"><span style=\"color: #000000;\">La NOM-059 es la norma que establece los requisitos m\u00ednimos de infraestructura, personal, documentaci\u00f3n, producci\u00f3n, control de calidad y sistemas de gesti\u00f3n que deben cumplir los establecimientos farmac\u00e9uticos para asegurar la calidad, seguridad y eficacia de los medicamentos.\u00a0<\/span><\/p><p style=\"font-weight: 400;\"><span style=\"color: #000000;\">Su cumplimiento es fundamental para:<\/span><\/p><ul style=\"font-weight: 400;\"><li><span style=\"color: #000000;\">Obtener y mantener autorizaciones sanitarias.<\/span><\/li><li><span style=\"color: #000000;\">Superar visitas de verificaci\u00f3n de COFEPRIS.<\/span><\/li><li><span style=\"color: #000000;\">Garantizar la calidad de los productos.<\/span><\/li><li><span style=\"color: #000000;\">Reducir riesgos de contaminaci\u00f3n o errores de fabricaci\u00f3n.<\/span><\/li><\/ul>\t\t\t\t\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-42fce7bf elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"42fce7bf\" data-element_type=\"section\" data-e-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=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-62fd7d8f\" data-id=\"62fd7d8f\" 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-7578b511 elementor-widget elementor-widget-heading\" data-id=\"7578b511\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Aspectos clave que eval\u00faa la NOM-059<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-19ee9c16 elementor-section-content-top elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"19ee9c16\" data-element_type=\"section\" data-e-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=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-13e28dc6\" data-id=\"13e28dc6\" 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-6d69bc79 elementor-widget elementor-widget-heading\" data-id=\"6d69bc79\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Sistema de Gesti\u00f3n de Calidad\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-74ad15bd elementor-widget elementor-widget-text-editor\" data-id=\"74ad15bd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400;\"><span style=\"color: #000000;\">La empresa debe contar con procedimientos documentados que aseguren el control de todas las actividades que impactan la calidad del producto.<\/span><\/p><p>\u00a0<\/p><p>\u00a0<\/p>\t\t\t\t\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-inner-column elementor-element elementor-element-e02bd44\" data-id=\"e02bd44\" 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-1a85d0a0 elementor-widget elementor-widget-heading\" data-id=\"1a85d0a0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Instalaciones y \u00e1reas de fabricaci\u00f3n\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5ae63068 elementor-widget elementor-widget-text-editor\" data-id=\"5ae63068\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400;\"><span style=\"color: #000000;\">Las instalaciones deben dise\u00f1arse para evitar:<\/span><\/p><ul style=\"font-weight: 400;\"><li><span style=\"color: #000000;\">Contaminaci\u00f3n cruzada y m<\/span><span style=\"color: #000000; font-style: inherit;\">ezclas accidentales de materiales\u00a0<\/span><\/li><li><span style=\"color: #000000; font-style: inherit;\">Confusiones durante la fabricaci\u00f3n.<\/span><\/li><\/ul><p><span style=\"color: #000000; font-size: 16px;\">Riesgos para el producto y el personal.<\/span><\/p>\t\t\t\t\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-inner-section elementor-element elementor-element-3813098 elementor-section-content-top elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3813098\" data-element_type=\"section\" data-e-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=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-92b33ba\" data-id=\"92b33ba\" 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-61e5d73 elementor-widget elementor-widget-heading\" data-id=\"61e5d73\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Personal competente<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-54a1706 elementor-widget elementor-widget-text-editor\" data-id=\"54a1706\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400;\"><span style=\"color: #000000;\">Todo el personal involucrado en fabricaci\u00f3n, control de calidad y aseguramiento de calidad debe recibir capacitaci\u00f3n continua y documentada.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-557b032 elementor-widget elementor-widget-heading\" data-id=\"557b032\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Control de calidad<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fc5d73a elementor-widget elementor-widget-text-editor\" data-id=\"fc5d73a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400;\"><span style=\"color: #000000;\">El laboratorio de control de calidad debe asegurar que materias primas, materiales de empaque y producto terminado cumplen con las especificaciones establecidas antes de su liberaci\u00f3n.<\/span><\/p>\t\t\t\t\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-inner-column elementor-element elementor-element-5e7b9d2\" data-id=\"5e7b9d2\" 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-cbafd6c elementor-widget elementor-widget-heading\" data-id=\"cbafd6c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Documentaci\u00f3n y registros<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d3c05a4 elementor-widget elementor-widget-text-editor\" data-id=\"d3c05a4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400;\"><span style=\"color: #000000;\">La trazabilidad es uno de los pilares de la NOM-059.<\/span><\/p><p style=\"font-weight: 400;\"><span style=\"color: #000000;\">La organizaci\u00f3n debe mantener:<\/span><\/p><ul style=\"font-weight: 400;\"><li><span style=\"color: #000000;\">Procedimientos normalizados de operaci\u00f3n.<\/span><\/li><li><span style=\"color: #000000;\">Registros de fabricaci\u00f3n.<\/span><\/li><li><span style=\"color: #000000;\">Registros de limpieza <\/span><\/li><li><span style=\"color: #000000;\">Registros de capacitaci\u00f3n.<\/span><\/li><li><span style=\"color: #000000; font-size: 16px;\">Bit\u00e1coras de equipos.<\/span><\/li><\/ul>\t\t\t\t\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 class=\"elementor-element elementor-element-155c773 elementor-widget elementor-widget-heading\" data-id=\"155c773\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Validaci\u00f3n y calificaci\u00f3n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d0ef061 elementor-widget elementor-widget-text-editor\" data-id=\"d0ef061\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400; text-align: center;\"><span style=\"color: #000000;\">La norma requiere evidencia documentada de:<\/span><\/p><ul style=\"font-weight: 400;\"><li style=\"text-align: left;\"><span style=\"color: #000000;\">Validaci\u00f3n de procesos.<\/span><\/li><li style=\"text-align: left;\"><span style=\"color: #000000;\">Validaci\u00f3n de limpieza.<\/span><\/li><li style=\"text-align: left;\"><span style=\"color: #000000;\">Validaci\u00f3n de m\u00e9todos anal\u00edticos.<\/span><\/li><li style=\"text-align: left;\"><span style=\"color: #000000;\">Calificaci\u00f3n de equipos.<\/span><\/li><li style=\"text-align: left;\"><span style=\"color: #000000;\">Calificaci\u00f3n de sistemas computarizados cuando aplique.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a571cb2 elementor-widget elementor-widget-heading\" data-id=\"a571cb2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Hallazgos frecuentes durante verificaciones regulatorias<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4f9f88e6 elementor-widget elementor-widget-text-editor\" data-id=\"4f9f88e6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400;\"><span style=\"color: #000000;\">Entre los incumplimientos m\u00e1s comunes se encuentran:<\/span><\/p><ul style=\"font-weight: 400;\"><li><span style=\"color: #000000;\">Procedimientos desactualizados.<\/span><\/li><li><span style=\"color: #000000;\">Registros incompletos.<\/span><\/li><li><span style=\"color: #000000;\">Falta de evidencia de capacitaci\u00f3n.<\/span><\/li><li><span style=\"color: #000000;\">Validaciones vencidas o insuficientes.<\/span><\/li><li><span style=\"color: #000000;\">Desviaciones sin investigaci\u00f3n adecuada.<\/span><\/li><li><span style=\"color: #000000;\">Control deficiente de cambios.<\/span><\/li><li><span style=\"color: #000000;\">Falta de an\u00e1lisis de riesgos.<\/span><\/li><\/ul><p><span style=\"font-weight: 400; color: #000000;\">Estos hallazgos pueden derivar en observaciones regulatorias, sanciones o incluso suspensiones de actividades.<\/span><\/p>\t\t\t\t\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-867b056 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"867b056\" data-element_type=\"section\" data-e-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=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-3b092b82\" data-id=\"3b092b82\" 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-6b08ce0e elementor-widget elementor-widget-heading\" data-id=\"6b08ce0e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Beneficios de implementar correctamente la NOM-059<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-530794a elementor-widget elementor-widget-text-editor\" data-id=\"530794a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400;\"><span style=\"color: #000000;\">Una adecuada implementaci\u00f3n permite:<\/span><\/p><p><span style=\"color: #000000;\"><span style=\"font-weight: 400;\">\u2705<\/span><span style=\"font-weight: 400;\"> Garantizar la calidad del producto.<br \/><\/span><span style=\"font-weight: 400;\">\u2705<\/span><span style=\"font-weight: 400;\"> Reducir desviaciones y reprocesos.<br \/><\/span><span style=\"font-weight: 400;\">\u2705<\/span><span style=\"font-weight: 400;\"> Cumplir con requisitos regulatorios de COFEPRIS.<br \/><\/span><span style=\"font-weight: 400;\">\u2705<\/span><span style=\"font-weight: 400;\"> Fortalecer la confianza de clientes y autoridades.<br \/><\/span><span style=\"font-weight: 400;\">\u2705<\/span><span style=\"font-weight: 400;\"> Facilitar auditor\u00edas y verificaciones.<br \/><\/span><span style=\"font-weight: 400;\">\u2705<\/span><span style=\"font-weight: 400;\"> Mejorar la eficiencia operativa.<\/span><\/span><\/p>\t\t\t\t\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-6835cd98\" data-id=\"6835cd98\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:2983,&quot;url&quot;:&quot;http:\\\/\\\/assig.com.mx\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/1.png&quot;}],&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_loop&quot;:&quot;yes&quot;,&quot;background_slideshow_slide_duration&quot;:5000,&quot;background_slideshow_slide_transition&quot;:&quot;fade&quot;,&quot;background_slideshow_transition_duration&quot;:500}\">\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9c1432d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9c1432d\" 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-100 elementor-top-column elementor-element elementor-element-3a22044\" data-id=\"3a22044\" 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-2eee6d5 elementor-widget elementor-widget-heading\" data-id=\"2eee6d5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Relaci\u00f3n con otros sistemas de gesti\u00f3n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-984f615 elementor-widget elementor-widget-text-editor\" data-id=\"984f615\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400;\"><span style=\"color: #000000;\">La NOM-059 puede integrarse con:<\/span><\/p><ul style=\"font-weight: 400;\"><li><span style=\"color: #000000;\">ISO 9001:2015<\/span><\/li><li><span style=\"color: #000000;\">ISO 17025<\/span><\/li><li><span style=\"color: #000000;\">ISO 15189<\/span><\/li><li><span style=\"color: #000000;\">Buenas Pr\u00e1cticas de Laboratorio (BPL)<\/span><\/li><li><span style=\"color: #000000;\">Validaci\u00f3n de Sistemas Computarizados<\/span><\/li><\/ul><p style=\"font-weight: 400;\"><span style=\"color: #000000;\">Esta integraci\u00f3n fortalece la gesti\u00f3n de calidad y el cumplimiento regulatorio.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b27c26a elementor-widget elementor-widget-heading\" data-id=\"b27c26a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">\u00bfC\u00f3mo te apoya ASSIG?<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eaae71d elementor-widget elementor-widget-text-editor\" data-id=\"eaae71d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400; text-align: center;\"><span style=\"color: #000000;\">En\u00a0<span style=\"color: #33cccc;\"><strong>ASSIG<\/strong><\/span>, apoyamos a las organizaciones con:<\/span><\/p><ul style=\"font-weight: 400;\"><li><span style=\"color: #000000;\">Diagn\u00f3stico de cumplimiento NOM-059.<\/span><\/li><li><span style=\"color: #000000;\">Implementaci\u00f3n de Buenas Pr\u00e1cticas de Fabricaci\u00f3n.<\/span><\/li><li><span style=\"color: #000000;\">Validaci\u00f3n de procesos y m\u00e9todos anal\u00edticos.<\/span><\/li><li><span style=\"color: #000000;\">Calificaci\u00f3n de equipos y sistemas.<\/span><\/li><li><span style=\"color: #000000;\">Gesti\u00f3n de riesgos.<\/span><\/li><li><span style=\"color: #000000;\">Auditor\u00edas internas y preparaci\u00f3n para verificaciones COFEPRIS.<\/span><\/li><li><span style=\"color: #000000;\">Capacitaci\u00f3n especializada.<\/span><\/li><\/ul><p style=\"font-weight: 400; text-align: center;\"><span style=\"color: #000000;\">Nuestro enfoque combina experiencia en sistemas de gesti\u00f3n, cumplimiento regulatorio y validaci\u00f3n farmac\u00e9utica.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3ecb706 elementor-widget elementor-widget-heading\" data-id=\"3ecb706\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Cont\u00e1ctanos hoy mismo para m\u00e1s informaci\u00f3n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-74f1403 elementor-widget elementor-widget-text-editor\" data-id=\"74f1403\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400; text-align: center;\"><span style=\"color: #000000;\">\ud83d\udcde\u00a0<span style=\"color: #33cccc;\"><strong>Tel\u00e9fono:<\/strong><\/span>\u00a0+52 220 492 9993<\/span><br \/><span style=\"color: #000000;\">\ud83d\udce7\u00a0<strong><span style=\"color: #33cccc;\">Correo:\u00a0<\/span><\/strong>contacto@assig.com.mx<\/span><br \/><span style=\"color: #000000;\"><span style=\"color: #33cccc;\"><strong>\ud83c\udf10\u00a0Sitio web:<\/strong><\/span>\u00a0www.assig.mx<\/span><\/p><p style=\"font-weight: 400; text-align: center;\"><span style=\"color: #33cccc;\">#NOM059 #COFEPRIS #BuenasPr\u00e1cticasDeFabricaci\u00f3n #IndustriaFarmac\u00e9utica #CalidadFarmac\u00e9utica #Validaci\u00f3n #AseguramientoDeCalidad #ASSIG #CumplimientoRegulatorio #Gesti\u00f3nDeCalidad #Medicamentos #BPF<\/span><\/p>\t\t\t\t\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>NOM-059-SSA1-2015: la base de las Buenas Pr\u00e1cticas de Fabricaci\u00f3n en la industria farmac\u00e9utica La calidad de un medicamento no puede [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1189,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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Debe construirse desde el dise\u00f1o de las instalaciones, la capacitaci\u00f3n del personal, los procesos de fabricaci\u00f3n y los controles de calidad. 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