{"id":2291,"date":"2025-10-24T16:06:27","date_gmt":"2025-10-24T19:06:27","guid":{"rendered":"https:\/\/blog.verifarma.com\/home\/?p=2291"},"modified":"2025-10-24T16:09:57","modified_gmt":"2025-10-24T19:09:57","slug":"anmat-controles-trazabilidad-farmaceutica-2025","status":"publish","type":"post","link":"https:\/\/blog.verifarma.com\/home\/sin-categorizar\/anmat-controles-trazabilidad-farmaceutica-2025\/","title":{"rendered":"Aumento de controles y clausuras en Argentina: por qu\u00e9 la trazabilidad es clave para la seguridad sanitaria"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#e2e2e2;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-1\"><h1><b>\u00a0Aumento de controles y clausuras en Argentina: por qu\u00e9 la trazabilidad es clave para la seguridad sanitaria<\/b><b><br \/>\n<\/b><\/h1>\n<p><span style=\"font-weight: 400;\">En 2025, la <a href=\"https:\/\/www.argentina.gob.ar\/anmat\">ANMAT<\/a> reforz\u00f3 fuertemente sus operativos de control en laboratorios y distribuidores farmac\u00e9uticos. Las clausuras recientes han estado vinculadas a fallas en calidad, producci\u00f3n, trazabilidad y documentaci\u00f3n, evidenciando que los organismos regulatorios exigen cada vez mayor transparencia y responsabilidad en toda la cadena de suministro.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Una de las medidas m\u00e1s relevantes fue la <a href=\"https:\/\/www.argentina.gob.ar\/normativa\/nacional\/disposici%C3%B3n-6223-2025-417108\">Disposici\u00f3n 6223\/2025,<\/a> mediante la cual <a href=\"https:\/\/www.argentina.gob.ar\/anmat\">ANMAT<\/a> dict\u00f3 una ampliaci\u00f3n del <a href=\"https:\/\/www.argentina.gob.ar\/anmat\/regulados\/sistema-nacional-de-trazabilidad\">Sistema Nacional de Trazabilidad<\/a>, con el objetivo de extender el listado de sustancias trazables y establecer criterios claros para la inclusi\u00f3n o exclusi\u00f3n de ingredientes farmac\u00e9uticos activos.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Estos cambios se enmarcan en una tendencia global: la calidad en Life Science debe entenderse como un proceso preventivo, donde los controles, la trazabilidad y la gesti\u00f3n documental se integran para anticipar desv\u00edos y fortalecer la seguridad sanitaria.<\/span><\/p>\n<h2><b>Tendencias recientes y principales causas de sanciones<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">En los \u00faltimos meses, distintos laboratorios y distribuidores han sido suspendidos o clausurados por incumplimientos cr\u00edticos en \u00e1reas como:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Falencias en control de calidad y producci\u00f3n.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Deficiencias en gesti\u00f3n documental y trazabilidad.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Contaminaci\u00f3n microbiol\u00f3gica y errores en procesos.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Desv\u00edos en condiciones de almacenamiento o transporte.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Estos hechos reflejan un mensaje claro: el margen de tolerancia regulatoria se reduce, y ya no alcanza con declaraciones de cumplimiento. Las evidencias deben estar documentadas, verificables y bajo control continuo.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Por qu\u00e9 la trazabilidad es esencial para la seguridad del paciente y las operaciones<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Un sistema robusto de <a href=\"https:\/\/www.verifarma.com\/soluciones-de-serializacion-de-medicamentos-y-dispositivos-medicos\/\">trazabilidad<\/a> permite:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identidad \u00fanica de cada unidad: cada envase o lote es identificable y rastreable.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Registro completo de movimientos: desde la producci\u00f3n hasta la dispensaci\u00f3n, con datos firmados y verificables.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Detecci\u00f3n temprana de irregularidades: alertas autom\u00e1ticas ante desviaciones o fallas en tiempo real.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Facilita auditor\u00edas regulatorias: toda acci\u00f3n queda documentada y disponible para inspecci\u00f3n.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Gracias a estos mecanismos, los laboratorios pueden prevenir riesgos sanitarios, evitar p\u00e9rdidas econ\u00f3micas y garantizar la seguridad del paciente con <a href=\"https:\/\/www.verifarma.com\/soluciones-de-serializacion-de-medicamentos-y-dispositivos-medicos\/\">trazabilidad verificable<\/a>.<\/span><\/p>\n<h2><b>Cumplimiento, integridad y auditabilidad con Verifarma<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Ante este contexto regulatorio m\u00e1s exigente, <a href=\"https:\/\/www.verifarma.com\/\">Verifarma<\/a> ofrece una suite completa de calidad preventiva, dise\u00f1ada para acompa\u00f1ar a la industria farmac\u00e9utica en sus procesos de cumplimiento y mejora continua:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.verifarma.com\/soluciones-de-serializacion-de-medicamentos-y-dispositivos-medicos\/\">Verifarma Track &amp; Trace<\/a> (T&amp;T): garantiza trazabilidad completa de productos farmac\u00e9uticos conforme a normativas locales e internacionales.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.verifarma.com\/verifarma-integrated-solutions\/\">Verifarma VIS<\/a>: integra los m\u00f3dulos <a href=\"https:\/\/landings.verifarma.com\/quality-management-system\/\">QMS<\/a>, <a href=\"https:\/\/landings.verifarma.com\/lims\/\">LIMS<\/a>, <a href=\"https:\/\/landings.verifarma.com\/sistema-de-gestion-de-asuntos-regulatorios\/\">RIMS<\/a> y <a href=\"https:\/\/landings.verifarma.com\/sistema-de-farmacovigilancia\/\">FVG<\/a>, que digitalizan procesos de calidad, centralizan documentaci\u00f3n y aseguran la integridad de datos, facilitando auditor\u00edas y evitando no conformidades.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Ambas soluciones funcionan de forma integrada, ofreciendo un ecosistema robusto que protege al paciente, asegura el cumplimiento regulatorio y garantiza la continuidad operativa.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La digitalizaci\u00f3n y la trazabilidad no son solo requisitos regulatorios: son herramientas estrat\u00e9gicas para construir una industria farmac\u00e9utica m\u00e1s segura, eficiente y confiable.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\ud83d\udca1 Si tu laboratorio o distribuidor a\u00fan no cuenta con un sistema de trazabilidad homologado, este es el momento de revisar su cumplimiento y adelantarte a sanciones.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\ud83d\udce9 Cont\u00e1ctanos para evaluar tu sistema y fortalecer tu operaci\u00f3n regulatoria.<\/span><\/p>\n<pre><\/pre>\n<\/div><a class=\"fusion-modal-text-link\" href=\"#\">\n<div class=\"pipedriveWebForms\" data-pd-webforms=\"https:\/\/webforms.pipedrive.com\/f\/1AD9KTQnadp0S3Qdz9j0JOQMzeiRcXQ6HnR14qBGeB5kxotp4Y0IXOwqwdUduAc2D\"><script src=\"https:\/\/webforms.pipedrive.com\/f\/loader\"><\/script><\/div>\n<\/a><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-0{width:100% !important;margin-top : 0px;margin-bottom : 20px;}.fusion-builder-column-0 > .fusion-column-wrapper {padding-top : 0px !important;padding-right : 0px !important;margin-right : 1.92%;padding-bottom : 0px !important;padding-left : 0px !important;margin-left : 1.92%;}@media only screen and (max-width:1024px) {.fusion-body .fusion-builder-column-0{width:100% !important;order : 0;}.fusion-builder-column-0 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-column-0{width:100% !important;order : 0;}.fusion-builder-column-0 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}<\/style><\/div><style type=\"text\/css\">.fusion-body .fusion-flex-container.fusion-builder-row-1{ padding-top : 0px;margin-top : 0px;padding-right : 0px;padding-bottom : 0px;margin-bottom : 0px;padding-left : 0px;}<\/style><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":11,"featured_media":2293,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2291","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sin-categorizar"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ANMAT refuerza controles: la trazabilidad es clave en 2025<\/title>\n<meta name=\"description\" content=\"En 2025, ANMAT ampli\u00f3 el Sistema Nacional de Trazabilidad. Conoc\u00e9 c\u00f3mo garantizar cumplimiento, calidad y seguridad sanitaria en tu laboratorio.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blog.verifarma.com\/home\/sin-categorizar\/anmat-controles-trazabilidad-farmaceutica-2025\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANMAT refuerza controles: la trazabilidad es clave en 2025\" \/>\n<meta property=\"og:description\" content=\"En 2025, ANMAT ampli\u00f3 el Sistema Nacional de Trazabilidad. 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