{"id":2298,"date":"2025-11-06T17:45:35","date_gmt":"2025-11-06T20:45:35","guid":{"rendered":"https:\/\/blog.verifarma.com\/home\/?p=2298"},"modified":"2025-11-06T17:45:35","modified_gmt":"2025-11-06T20:45:35","slug":"anmat-controles-gestion-calidad-laboratorios-latam","status":"publish","type":"post","link":"https:\/\/blog.verifarma.com\/home\/sin-categorizar\/anmat-controles-gestion-calidad-laboratorios-latam\/","title":{"rendered":"La ANMAT en Argentina refuerza los controles: c\u00f3mo fortalecer la gesti\u00f3n de calidad en tu laboratorio"},"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>La ANMAT en Argentina refuerza los controles: c\u00f3mo fortalecer la gesti\u00f3n de calidad en tu laboratorio<\/b><\/h1>\n<p><span style=\"font-weight: 400;\">Las recientes clausuras realizadas por la <a href=\"https:\/\/www.argentina.gob.ar\/anmat\">ANMAT<\/a> en Argentina reflejan una tendencia que atraviesa a toda Latinoam\u00e9rica: los organismos regulatorios est\u00e1n intensificando la supervisi\u00f3n sobre los <a href=\"https:\/\/www.verifarma.com\/verifarma-integrated-solutions\/\">procesos de calidad<\/a>, <a href=\"https:\/\/www.verifarma.com\/soluciones-de-serializacion-de-medicamentos-y-dispositivos-medicos\/\">trazabilidad<\/a> y documentaci\u00f3n en la industria farmac\u00e9utica.<\/span><\/p>\n<h2><b>La calidad, en el centro de la agenda regulatoria<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">En las \u00faltimas semanas, la <\/span><b><a href=\"https:\/\/www.argentina.gob.ar\/anmat\">ANMAT<\/a> (Argentina)<\/b><span style=\"font-weight: 400;\"> clausur\u00f3 diversos laboratorios y distribuidoras por irregularidades en sus sistemas de calidad, trazabilidad y documentaci\u00f3n.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\"> Casos similares se han registrado en otros pa\u00edses de la regi\u00f3n, donde los entes regulatorios est\u00e1n <\/span><b>elevando los est\u00e1ndares de cumplimiento y transparencia<\/b><span style=\"font-weight: 400;\"> en toda la cadena farmac\u00e9utica.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">M\u00e1s que nunca, la <\/span><a href=\"https:\/\/www.verifarma.com\/verifarma-integrated-solutions\/\"><b>gesti\u00f3n de calidad<\/b><\/a><span style=\"font-weight: 400;\"> se consolida como un pilar estrat\u00e9gico para garantizar la seguridad del paciente y la continuidad operativa de las organizaciones.<\/span><\/p>\n<h2><b>Por qu\u00e9 se sancionan laboratorios en la regi\u00f3n<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Las medidas adoptadas por distintos organismos sanitarios suelen tener origen en falencias recurrentes como:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Falta de trazabilidad en los procesos productivos.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Documentaci\u00f3n incompleta o desactualizada.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Registros manuales sin control de versiones.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Desviaciones sin seguimiento o cierre adecuado.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Brechas entre las \u00e1reas de producci\u00f3n, control y calidad.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Cuando estos elementos fallan, se pierde el control sobre la integridad del producto y se compromete la seguridad de los pacientes.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\"> Por eso, <\/span><b>contar con un sistema integral de gesti\u00f3n de calidad<\/b><span style=\"font-weight: 400;\"> no es solo una exigencia regulatoria, sino una garant\u00eda de <\/span><b>transparencia, trazabilidad y cumplimiento<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><b>5 se\u00f1ales de alerta antes de una auditor\u00eda sanitaria<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Las auditor\u00edas regulatorias \u2014ya sea por <a href=\"https:\/\/www.argentina.gob.ar\/anmat\">ANMAT<\/a>, <a href=\"https:\/\/www.invima.gov.co\/\">INVIMA<\/a>, <a href=\"https:\/\/dinavisa.gov.py\/\">DINAVISA<\/a>, <\/span><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\">ANVISA<\/a>, <\/span><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.gob.mx\/cofepris\">COFEPRIS<\/a> u otras autoridades de la regi\u00f3n\u2014 son cada vez m\u00e1s exigentes y minuciosas.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\"> Identificar debilidades a tiempo puede marcar la diferencia entre una observaci\u00f3n menor y una sanci\u00f3n grave.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Cinco se\u00f1ales de alerta que indican que tu laboratorio podr\u00eda no estar preparado:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Registros manuales o inconsistentes.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Dificultad para localizar documentos o versiones aprobadas.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Procesos de calidad descentralizados.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Falta de trazabilidad entre \u00e1reas.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Desconocimiento de actualizaciones regulatorias.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">Implementar una <\/span><b>plataforma digital integrada<\/b><span style=\"font-weight: 400;\"> permite centralizar informaci\u00f3n, automatizar procesos y reducir riesgos ante una inspecci\u00f3n.<\/span><\/p>\n<h2><b>C\u00f3mo prepararte para los nuevos controles en Latinoam\u00e9rica<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Ante el refuerzo de los controles regulatorios, los laboratorios deben revisar su sistema de gesti\u00f3n y asegurarse de cumplir con los est\u00e1ndares internacionales.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\"> Algunos pasos clave:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Verificar que los sistemas est\u00e9n homologados y actualizados.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Digitalizar y asegurar el acceso a toda la documentaci\u00f3n regulatoria.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Realizar simulacros de auditor\u00eda interna.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Capacitar al equipo sobre las disposiciones de cada autoridad sanitaria.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Contar con un proveedor calificado que acompa\u00f1e el proceso.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Estas pr\u00e1cticas no solo facilitan auditor\u00edas, sino que <\/span><b>refuerzan la eficiencia y trazabilidad<\/b><span style=\"font-weight: 400;\"> en cada etapa del ciclo productivo.<\/span><\/p>\n<h2><b>C\u00f3mo Verifarma ayuda a garantizar la calidad y el cumplimiento<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">En Verifarma acompa\u00f1amos a laboratorios y distribuidores de toda la regi\u00f3n con soluciones dise\u00f1adas para asegurar cumplimiento normativo y trazabilidad total:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>VIS QMS<\/b><span style=\"font-weight: 400;\">: sistema integral de gesti\u00f3n de calidad que permite documentar, controlar y auditar todos los procesos bajo las normativas de <\/span><b>ANMAT, INVIMA, COFEPRIS, DIGEMID<\/b><span style=\"font-weight: 400;\"> y organismos internacionales.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Track &amp; Trace<\/b><span style=\"font-weight: 400;\">: soluci\u00f3n de trazabilidad que garantiza el seguimiento de cada producto, desde su fabricaci\u00f3n hasta su distribuci\u00f3n.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Ambas soluciones trabajan de forma integrada para ofrecer una visi\u00f3n <\/span><b>completa, segura y actualizada<\/b><span style=\"font-weight: 400;\"> del estado de calidad en la organizaci\u00f3n.<\/span><\/p>\n<h2><b>La calidad como compromiso<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">La calidad no es solo una obligaci\u00f3n regulatoria: es un <\/span><b>compromiso con la seguridad, la confianza y la reputaci\u00f3n<\/b><span style=\"font-weight: 400;\"> del laboratorio.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\"> Contar con las herramientas adecuadas permite anticiparse a los desaf\u00edos regulatorios y fortalecer la posici\u00f3n de la empresa en un entorno cada vez m\u00e1s exigente.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\ud83d\udc49 <\/span><b>Conoc\u00e9 c\u00f3mo VIS y Track &amp; Trace pueden ayudarte a preparar tu laboratorio para los nuevos controles.<\/b><b><br \/>\n<\/b><\/p>\n<\/div><a class=\"fusion-modal-text-link\" href=\"#\">\r\n<div class=\"pipedriveWebForms\" data-pd-webforms=\"https:\/\/webforms.pipedrive.com\/f\/1AD9KTQnadp0S3Qdz9j0JOQMzeiRcXQ6HnR14qBGeB5kxotp4Y0IXOwqwdUduAc2D\"><script src=\"https:\/\/webforms.pipedrive.com\/f\/loader\"><\/script><\/div>\r\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 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0px;}<\/style><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":11,"featured_media":2299,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2298","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>La ANMAT refuerza los controles: gesti\u00f3n de calidad en laboratorios<\/title>\n<meta name=\"description\" content=\"Los organismos sanitarios de LATAM intensifican los controles. 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