{"id":4768,"date":"2026-03-16T11:19:00","date_gmt":"2026-03-16T11:19:00","guid":{"rendered":"https:\/\/www.consultlhasa.com\/?post_type=blog&#038;p=4768"},"modified":"2026-03-31T11:20:43","modified_gmt":"2026-03-31T10:20:43","slug":"ema-reflection-paper-non-mutagenic-impurities","status":"publish","type":"blog","link":"https:\/\/www.consultlhasa.com\/es\/blog\/ema-reflection-paper-non-mutagenic-impurities\/","title":{"rendered":"C\u00f3mo impacta el documento de reflexi\u00f3n de la EMA en la calificaci\u00f3n de impurezas no mutag\u00e9nicas"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"4768\" class=\"elementor elementor-4768\" data-elementor-post-type=\"blog\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b75e48d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b75e48d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-27e5785\" data-id=\"27e5785\" 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-a22eede elementor-widget elementor-widget-text-editor\" data-id=\"a22eede\" 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 class=\"translation-block\">La Agencia Europea de Medicamentos (EMA) ha publicado su documento de reflexi\u00f3n final sobre la calificaci\u00f3n de impurezas no mutag\u00e9nicas. La gu\u00eda aclara c\u00f3mo los equipos de Asuntos Regulatorios, Toxicolog\u00eda y CMC deben abordar en la pr\u00e1ctica las impurezas no mutag\u00e9nicas (NMIs), reforzando el uso de evaluaciones estructuradas del riesgo y de las Nuevas Metodolog\u00edas de Enfoque (NAMs).<\/p><p>Esto representa un avance positivo hacia una mayor claridad en un \u00e1rea que, con frecuencia, ha dependido del criterio experto y de interpretaciones caso por caso.<\/p><p>Las impurezas no mutag\u00e9nicas se encuentran en un \u00e1mbito m\u00e1s complejo que las impurezas mutag\u00e9nicas. Mientras que para la mutagenicidad existen marcos de evaluaci\u00f3n bien establecidos, las NMIs requieren una evaluaci\u00f3n toxicol\u00f3gica m\u00e1s amplia y una justificaci\u00f3n proporcional basada en el riesgo.\n\nEl nuevo documento no modifica los fundamentos cient\u00edficos existentes, pero proporciona una estructura m\u00e1s clara sobre c\u00f3mo los equipos pueden desarrollar y justificar decisiones basadas en el riesgo utilizando los datos disponibles, as\u00ed como aplicar las Nuevas Metodolog\u00edas de Enfoque (NAMs).<\/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-7c14fe8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7c14fe8\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-f44f59e\" data-id=\"f44f59e\" 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-11b99d3 elementor-widget elementor-widget-image\" data-id=\"11b99d3\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-02.png\" class=\"attachment-large size-large wp-image-4016\" alt=\"\" \/>\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<div class=\"elementor-element elementor-element-1e680df elementor-widget elementor-widget-text-editor\" data-id=\"1e680df\" 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<blockquote><p>El documento de reflexi\u00f3n aporta una estructura muy necesaria a la evaluaci\u00f3n de impurezas, aclarando c\u00f3mo deben aplicarse las NAMs y los enfoques de read-across para garantizar que las decisiones sean cient\u00edficamente s\u00f3lidas y est\u00e9n justificadas de manera consistente.<\/p><p><strong>Dr Gabriela Silveira, Lead Scientific Consultant<\/strong><\/p><\/blockquote>\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-d2ad0f2 elementor-widget elementor-widget-image\" data-id=\"d2ad0f2\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-01.png\" class=\"attachment-large size-large wp-image-4015\" alt=\"\" \/>\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-a18ebd5\" data-id=\"a18ebd5\" 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-16a4182 elementor-widget elementor-widget-image\" data-id=\"16a4182\" 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=\"1024\" height=\"1024\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/3-1.png\" class=\"attachment-large size-large wp-image-4786\" alt=\"Dr Gabriela Silveira, Lead Scientific Consultant - EMA NMI reflection paper\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/3-1.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/3-1-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/3-1-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/3-1-768x768.png 768w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/3-1-12x12.png 12w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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-60e8b2d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"60e8b2d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-fbadd2e\" data-id=\"fbadd2e\" 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-50173a7 elementor-widget elementor-widget-heading\" data-id=\"50173a7\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Priorizaci\u00f3n de las NAMs dentro de una evaluaci\u00f3n estructurada<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-92c3081 elementor-widget elementor-widget-text-editor\" data-id=\"92c3081\" 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 class=\"translation-block\">Un mensaje claro a lo largo del documento es que las NAMs deben considerarse el punto de partida para la calificaci\u00f3n de impurezas. Las metodolog\u00edas (Q)SAR, el read-across, el umbral de preocupaci\u00f3n toxicol\u00f3gica (TTC) y los m\u00e9todos <em>in vitro<\/em> constituyen herramientas fundamentales para desarrollar una justificaci\u00f3n toxicol\u00f3gica antes de considerar estudios <em>in vivo<\/em>.<\/p><p>En la evaluaci\u00f3n de impurezas, este cambio es especialmente relevante. Generar nuevos datos experimentales para impurezas presentes en niveles bajos no siempre resulta proporcional ni pr\u00e1ctico, por lo que el enfoque se orienta hacia el aprovechamiento eficaz del conocimiento disponible y de los m\u00e9todos computacionales.<\/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-2c64717 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2c64717\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-e641f10\" data-id=\"e641f10\" 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-398e5af elementor-widget elementor-widget-image\" data-id=\"398e5af\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-02.png\" class=\"attachment-large size-large wp-image-4016\" alt=\"\" \/>\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<div class=\"elementor-element elementor-element-12a2377 elementor-widget elementor-widget-text-editor\" data-id=\"12a2377\" 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<blockquote><p class=\"translation-block\">En el \u00e1mbito de las impurezas, no siempre resulta sencillo generar nuevos datos <em>in vitro<\/em>, por lo que esperamos que el componente computacional de las NAMs siga ganando relevancia, acompa\u00f1ado de ejemplos m\u00e1s claros y una mayor armonizaci\u00f3n en la aplicaci\u00f3n de estos enfoques.<\/p><p><strong>Dr Martyn Chilton DABT, Scientific Consultant<\/strong><\/p><\/blockquote>\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-69750aa elementor-widget elementor-widget-image\" data-id=\"69750aa\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-01.png\" class=\"attachment-large size-large wp-image-4015\" alt=\"\" \/>\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-7b29ca3\" data-id=\"7b29ca3\" 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-bb8892c elementor-widget elementor-widget-image\" data-id=\"bb8892c\" 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 loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1.png\" class=\"attachment-large size-large wp-image-4788\" alt=\"Dr Martyn Chilton DABT Scientific Consultant - EMA NMI reflection paper\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1-768x768.png 768w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1-12x12.png 12w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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-60e09ed elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"60e09ed\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-ce50e2d\" data-id=\"ce50e2d\" 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-80c1579 elementor-widget elementor-widget-text-editor\" data-id=\"80c1579\" 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>La elaboraci\u00f3n de una evaluaci\u00f3n s\u00f3lida basada en el peso de la evidencia (Weight of Evidence, WoE) requiere herramientas adecuadas y una interpretaci\u00f3n experta rigurosa de sus resultados. La clave no reside en cada herramienta por separado, sino en c\u00f3mo se integran e interpretan las distintas l\u00edneas de evidencia.\n\nUn razonamiento estructurado y claramente documentado sigue siendo fundamental.<\/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-d2eb4f0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d2eb4f0\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-8f4f6c9\" data-id=\"8f4f6c9\" 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-0ad49d9 elementor-widget elementor-widget-heading\" data-id=\"0ad49d9\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Cu\u00e1ndo se requiere la calificaci\u00f3n de impurezas no mutag\u00e9nicas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bb2a137 elementor-widget elementor-widget-text-editor\" data-id=\"bb2a137\" 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 class=\"translation-block\">La calificaci\u00f3n se vuelve necesaria cuando los niveles de impurezas superan los umbrales establecidos en las gu\u00edas ICH Q3A o ICH Q3B, teniendo en cuenta la dosis m\u00e1xima diaria y las consideraciones de exposici\u00f3n. En ese momento, es necesario demostrar que la impureza es segura en el nivel observado.<\/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-b978b7d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b978b7d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-b070810\" data-id=\"b070810\" 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-7e3e233 elementor-widget elementor-widget-image\" data-id=\"7e3e233\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-02.png\" class=\"attachment-large size-large wp-image-4016\" alt=\"\" \/>\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<div class=\"elementor-element elementor-element-23bacb5 elementor-widget elementor-widget-text-editor\" data-id=\"23bacb5\" 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<blockquote><p>La evaluaci\u00f3n comienza con los umbrales de calificaci\u00f3n establecidos en las gu\u00edas ICH Q3A y Q3B. Cuando una impureza supera estos umbrales, es necesario evaluar su toxicidad para demostrar que es segura en el nivel de exposici\u00f3n observado.<\/p><p><strong>Dr Martyn Chilton DABT, Scientific Consultant<\/strong><\/p><\/blockquote>\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-94356be elementor-widget elementor-widget-image\" data-id=\"94356be\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-01.png\" class=\"attachment-large size-large wp-image-4015\" alt=\"\" \/>\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-792449d\" data-id=\"792449d\" 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-3c5ebd2 elementor-widget elementor-widget-image\" data-id=\"3c5ebd2\" 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 loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1.png\" class=\"attachment-large size-large wp-image-4788\" alt=\"Dr Martyn Chilton DABT Scientific Consultant - EMA NMI reflection paper\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1-768x768.png 768w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1-12x12.png 12w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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-7656cf9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7656cf9\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-4c1becf\" data-id=\"4c1becf\" 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-a267e63 elementor-widget elementor-widget-text-editor\" data-id=\"a267e63\" 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>El documento de reflexi\u00f3n tambi\u00e9n proporciona ejemplos adicionales de situaciones que pueden requerir la calificaci\u00f3n de impurezas, incluidos cambios en el proceso, nuevas v\u00edas de degradaci\u00f3n o impurezas identificadas en etapas avanzadas. Estos ejemplos ayudan a los equipos a anticipar las expectativas regulatorias desde fases m\u00e1s tempranas del desarrollo y durante la gesti\u00f3n del ciclo de vida del producto.<\/p><p>En la pr\u00e1ctica, una calificaci\u00f3n eficaz de impurezas no mutag\u00e9nicas combina los umbrales regulatorios, las consideraciones de exposici\u00f3n y una evaluaci\u00f3n toxicol\u00f3gica estructurada dentro de una justificaci\u00f3n coherente.<\/p><p>De este modo, el documento de reflexi\u00f3n de la EMA proporciona un marco m\u00e1s claro sobre c\u00f3mo deben calificarse las impurezas no mutag\u00e9nicas en el desarrollo farmac\u00e9utico y en las presentaciones regulatorias.<\/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-d25b298 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d25b298\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-6f467c8\" data-id=\"6f467c8\" 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-8b2b79d elementor-widget elementor-widget-heading\" data-id=\"8b2b79d\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Evaluaci\u00f3n de riesgos en la calificaci\u00f3n de impurezas no mutag\u00e9nicas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fd162c4 elementor-widget elementor-widget-text-editor\" data-id=\"fd162c4\" 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>Las decisiones de calificaci\u00f3n rara vez se basan en un \u00fanico par\u00e1metro. Los cient\u00edficos deben considerar de manera conjunta el nivel de preocupaci\u00f3n, la exposici\u00f3n, el contexto cl\u00ednico y el perfil de peligrosidad de la impureza.<\/p><p>En la pr\u00e1ctica, esto implica evaluar la impureza dentro del contexto global del producto. Una impureza que, considerando \u00fanicamente su peligrosidad, pueda parecer de bajo riesgo, podr\u00eda requerir una evaluaci\u00f3n adicional al tener en cuenta la exposici\u00f3n o la v\u00eda de administraci\u00f3n.\n\nDel mismo modo, la exposici\u00f3n puede ser lo suficientemente limitada como para respaldar una conclusi\u00f3n proporcional basada en el riesgo.<\/p><p>El flujo estructurado presentado en la gu\u00eda favorece la aplicaci\u00f3n coherente de estos principios. Proporciona un marco de referencia claro, pero el criterio cient\u00edfico sigue siendo fundamental para interpretar la evidencia dentro de su contexto.<\/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-66089e3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"66089e3\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-8e69d10\" data-id=\"8e69d10\" 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-8f9b394 elementor-widget elementor-widget-heading\" data-id=\"8f9b394\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Interpretaci\u00f3n de la similitud con el API<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-43e5597 elementor-widget elementor-widget-text-editor\" data-id=\"43e5597\" 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>La explicaci\u00f3n del concepto de impurezas \u00absimilares al API\u00bb se desarrolla de manera m\u00e1s clara en la versi\u00f3n final del documento de reflexi\u00f3n.<\/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-85dbdc9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"85dbdc9\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-fc9eaa4\" data-id=\"fc9eaa4\" 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-909e69c elementor-widget elementor-widget-image\" data-id=\"909e69c\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-02.png\" class=\"attachment-large size-large wp-image-4016\" alt=\"\" \/>\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<div class=\"elementor-element elementor-element-759499b elementor-widget elementor-widget-text-editor\" data-id=\"759499b\" 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<blockquote><p>La similitud con el API no puede basarse \u00fanicamente en la similitud estructural. Lo fundamental es comprender si cualquier modificaci\u00f3n influye en el comportamiento toxicol\u00f3gico de la impureza, y el documento proporciona orientaciones m\u00e1s claras sobre c\u00f3mo establecer esta distinci\u00f3n.<\/p><p><strong>Dr Gabriela Silveira, Lead Scientific Consultant<\/strong><\/p><\/blockquote>\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-4b5ed72 elementor-widget elementor-widget-image\" data-id=\"4b5ed72\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-01.png\" class=\"attachment-large size-large wp-image-4015\" alt=\"\" \/>\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-78c032b\" data-id=\"78c032b\" 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-2001efd elementor-widget elementor-widget-image\" data-id=\"2001efd\" 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=\"1024\" height=\"1024\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/3-1.png\" class=\"attachment-large size-large wp-image-4786\" alt=\"Dr Gabriela Silveira, Lead Scientific Consultant - EMA NMI reflection paper\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/3-1.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/3-1-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/3-1-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/3-1-768x768.png 768w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/3-1-12x12.png 12w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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-d93a463 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d93a463\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-2a22619\" data-id=\"2a22619\" 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-e2ad610 elementor-widget elementor-widget-text-editor\" data-id=\"e2ad610\" 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>Esta aclaraci\u00f3n tambi\u00e9n beneficia los enfoques de read-across. La similitud debe justificarse desde una perspectiva biol\u00f3gica y toxicol\u00f3gica, y no basarse \u00fanicamente en la similitud estructural.<\/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-4cd8f5d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4cd8f5d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-0299ca0\" data-id=\"0299ca0\" 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-d76559c elementor-widget elementor-widget-heading\" data-id=\"d76559c\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Aplicaci\u00f3n de la v\u00eda del metabolito en la calificaci\u00f3n de impurezas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb12f9f elementor-widget elementor-widget-text-editor\" data-id=\"cb12f9f\" 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>The metabolite pathway remains an important route within non-mutagenic impurity qualification. The guidance clarifies that metabolite status alone is not sufficient and that relative exposure and overall toxicological context should also be considered.<\/p><p>Where an <a href=\"https:\/\/www.consultlhasa.com\/es\/blog\/non-mutagenic-impurity-qualification-workflow\/?utm_source=blog&amp;utm_medium=online&amp;utm_campaign=EMA+reflection+paper+NMI+\">impurity can be demonstrated to be a significant metabolite of the API<\/a>, this may support qualification. However, this is not automatic. The assessment still needs to consider relative exposure and whether the additional exposure from the impurity meaningfully alters the overall safety profile.<\/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-ff5c3bf elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ff5c3bf\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-d1152bc\" data-id=\"d1152bc\" 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-8204bf5 elementor-widget elementor-widget-image\" data-id=\"8204bf5\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-02.png\" class=\"attachment-large size-large wp-image-4016\" alt=\"\" \/>\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<div class=\"elementor-element elementor-element-c89381c elementor-widget elementor-widget-text-editor\" data-id=\"c89381c\" 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<blockquote><p>The key is to demonstrate that, considering the patient\u2019s actual exposure, the toxicological profile remains appropriate, always in a proportional and well-justified manner.<\/p><p><strong>Dr Arianne Rivellis, Director of Global Operations<\/strong><\/p><\/blockquote>\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-882afc7 elementor-widget elementor-widget-image\" data-id=\"882afc7\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-01.png\" class=\"attachment-large size-large wp-image-4015\" alt=\"\" \/>\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-3fe9e0f\" data-id=\"3fe9e0f\" 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-f4e7468 elementor-widget elementor-widget-image\" data-id=\"f4e7468\" 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 loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1.png\" class=\"attachment-large size-large wp-image-4787\" alt=\"Dr Ariane Rivellis, Director of Global Operations - EMA NMI reflection paper\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1-768x768.png 768w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1-12x12.png 12w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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-0640d33 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0640d33\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-1c1d173\" data-id=\"1c1d173\" 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-4277249 elementor-widget elementor-widget-text-editor\" data-id=\"4277249\" 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>Across each pathway, teams must support their conclusions with transparent reasoning and available data.<\/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-3ef601d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3ef601d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-d774157\" data-id=\"d774157\" 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-b192a3f elementor-widget elementor-widget-heading\" data-id=\"b192a3f\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Aligning toxicology with manufacturing reality<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e44c802 elementor-widget elementor-widget-text-editor\" data-id=\"e44c802\" 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>A particularly practical clarification relates to how impurity specification limits should be justified. Justification should be grounded in batch data and stability observations, rather than theoretical limits alone.<\/p><p>In application, this requires alignment between toxicology, analytical and CMC functions. Qualification decisions should reflect the impurity levels that are observed and the consistency of manufacturing processes.<\/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-a7baf2c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a7baf2c\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-d7b1d64\" data-id=\"d7b1d64\" 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-b7f51c5 elementor-widget elementor-widget-image\" data-id=\"b7f51c5\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-02.png\" class=\"attachment-large size-large wp-image-4016\" alt=\"\" \/>\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<div class=\"elementor-element elementor-element-3b899d2 elementor-widget elementor-widget-text-editor\" data-id=\"3b899d2\" 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<blockquote><p>The strongest justification is always the one grounded in our own data. Basing the qualification on the impurity levels observed in batches and stability studies makes the assessment far more robust and realistic.<\/p><p><strong>Dr Arianne Rivellis, Director of Global Operations<\/strong><\/p><\/blockquote>\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-b67eba6 elementor-widget elementor-widget-image\" data-id=\"b67eba6\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-01.png\" class=\"attachment-large size-large wp-image-4015\" alt=\"\" \/>\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-73f39df\" data-id=\"73f39df\" 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-75a52e7 elementor-widget elementor-widget-image\" data-id=\"75a52e7\" 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 loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1.png\" class=\"attachment-large size-large wp-image-4787\" alt=\"Dr Ariane Rivellis, Director of Global Operations - EMA NMI reflection paper\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1-768x768.png 768w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1-12x12.png 12w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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-ccf7aca elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ccf7aca\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-28cef2a\" data-id=\"28cef2a\" 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-bc07b8c elementor-widget elementor-widget-heading\" data-id=\"bc07b8c\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Route of administration shapes the question<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-43fddd9 elementor-widget elementor-widget-text-editor\" data-id=\"43fddd9\" 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>Risk cannot be evaluated independently of exposure route. Oral, topical, inhaled and parenteral products present different considerations.<\/p><p>For topical products, sensitisation may be a key endpoint depending on exposure profile and product use. Ensuring that the assessment reflects route-specific considerations supports proportionate and scientifically appropriate conclusions.<\/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-8576c48 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8576c48\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-17178e0\" data-id=\"17178e0\" 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-af80d3b elementor-widget elementor-widget-image\" data-id=\"af80d3b\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-02.png\" class=\"attachment-large size-large wp-image-4016\" alt=\"\" \/>\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<div class=\"elementor-element elementor-element-4e61005 elementor-widget elementor-widget-text-editor\" data-id=\"4e61005\" 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<blockquote><p>Route of administration changes what types of toxicity needs to be considered. With topical products, local effects matter more, and sensitisation is often one of the most sensitive endpoints to consider.<\/p><p><strong>Dr Martyn Chilton DABT, Scientific Consultant<\/strong><\/p><\/blockquote>\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-b9eeee0 elementor-widget elementor-widget-image\" data-id=\"b9eeee0\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-01.png\" class=\"attachment-large size-large wp-image-4015\" alt=\"\" \/>\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-ad8e127\" data-id=\"ad8e127\" 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-70773cf elementor-widget elementor-widget-image\" data-id=\"70773cf\" 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 loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1.png\" class=\"attachment-large size-large wp-image-4788\" alt=\"Dr Martyn Chilton DABT Scientific Consultant - EMA NMI reflection paper\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1-768x768.png 768w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/5-1-12x12.png 12w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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-64e8e8d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"64e8e8d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-0d52361\" data-id=\"0d52361\" 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-3d38af0 elementor-widget elementor-widget-heading\" data-id=\"3d38af0\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Lo que esto significa para la calificaci\u00f3n de impurezas no mutag\u00e9nicas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b3b9d2e elementor-widget elementor-widget-text-editor\" data-id=\"b3b9d2e\" 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>Al aplicar esta gu\u00eda, siguen siendo fundamentales cinco consideraciones pr\u00e1cticas:<\/p><ol><li>Define clearly what triggers qualification for your product.<\/li><li>Prioritise NAMs and structured weight of evidence approaches.<\/li><li>Ensure endpoints align with route of administration and exposure.<\/li><li>Anchor justifications to observed data from stability and manufacturing.<\/li><li>Document reasoning transparently and proportionately.<\/li><\/ol>\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-e8b51fb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e8b51fb\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-2cd695d\" data-id=\"2cd695d\" 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-dbf446a elementor-widget elementor-widget-image\" data-id=\"dbf446a\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-02.png\" class=\"attachment-large size-large wp-image-4016\" alt=\"\" \/>\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<div class=\"elementor-element elementor-element-baa5145 elementor-widget elementor-widget-text-editor\" data-id=\"baa5145\" 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<blockquote><p>We already have a significant body of chemical and toxicological knowledge. The opportunity is to use it better, share information where appropriate, and avoid repeating work unnecessarily.<\/p><p><strong>Dr Arianne Rivellis, Director of Global Operations<\/strong><\/p><\/blockquote>\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-d9cf9bf elementor-widget elementor-widget-image\" data-id=\"d9cf9bf\" 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=\"297\" height=\"221\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/04\/speech-mark-icons-01.png\" class=\"attachment-large size-large wp-image-4015\" alt=\"\" \/>\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-7210736\" data-id=\"7210736\" 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-6207bfb elementor-widget elementor-widget-image\" data-id=\"6207bfb\" 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 loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1.png\" class=\"attachment-large size-large wp-image-4787\" alt=\"Dr Ariane Rivellis, Director of Global Operations - EMA NMI reflection paper\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1-768x768.png 768w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/03\/4-1-12x12.png 12w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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-392d055 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"392d055\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-0f1e5b7\" data-id=\"0f1e5b7\" 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-e56b1be elementor-widget elementor-widget-text-editor\" data-id=\"e56b1be\" 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>The principles reinforced here are consistent with the approach Consult Lhasa applies when supporting impurity qualification.<\/p><p>Our teams of expert scientific consultants work with industry partners to build structured, transparent justifications for non-mutagenic impurities, combining <a href=\"https:\/\/www.lhasalimited.org\/solutions\/?utm_source=blog&amp;utm_medium=online&amp;utm_campaign=EMA+reflection+paper+NMI\" target=\"_blank\" rel=\"noopener\"><em>in silico<\/em> tools<\/a>, read-across strategies and expert toxicological evaluation to ensure decisions are proportionate and clearly documented.<\/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-683a5e0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"683a5e0\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-169dd28\" data-id=\"169dd28\" 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-9c63d40 elementor-widget elementor-widget-heading\" data-id=\"9c63d40\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Further reading<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2a1c2c8 elementor-widget elementor-widget-text-editor\" data-id=\"2a1c2c8\" 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>Further information on the EMA reflection paper can be found here:<\/p><p><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/reflection-paper-qualification-non-mutagenic-impurities_en.pdf#:~:text=The%20ICH%20Q3A%28R2%29%20and%20Q3B%28R2%29%20guidelines%20provide%20a,been%20completed%20for%20initial%20Marketing%20Authorisation%20Applications%20%28MAAs%29.\" target=\"_blank\" rel=\"noopener\">Reflection paper on the qualification of non-mutagenic impurities<\/a><\/p><p>For a discussion-style walkthrough of the guidance and its practical implications, Spektra recently hosted a podcast conversation with Consult Lhasa consultants Arianne and Martyn:<\/p><p><a href=\"https:\/\/www.youtube.com\/watch?v=CQoSyG7TxXQ\" target=\"_blank\" rel=\"noopener\">The Revolution in Impurity Qualification: Discover the New EMA Guide!<\/a><\/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-f11d2d8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f11d2d8\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-34cb738\" data-id=\"34cb738\" 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\t<div class=\"elementor-element elementor-element-3304e54 elementor-widget elementor-widget-heading\" data-id=\"3304e54\" 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<h2 class=\"elementor-heading-title elementor-size-default\"><span style=\"letter-spacing: 0.1px\">Contact Consult Lhasa<\/span><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ac1875e elementor-widget elementor-widget-text-editor\" data-id=\"ac1875e\" 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>For expert, scientifically robust, and defensible nitrosamine safety risk assessments.<\/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-370ea2d elementor-align-center elementor-widget elementor-widget-button\" data-id=\"370ea2d\" 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-md\" href=\"https:\/\/www.consultlhasa.com\/es\/contact-us\/\">\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\">Request a call<\/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>","protected":false},"featured_media":2700,"template":"","meta":{"_acf_changed":false,"content-type":"","site-sidebar-layout":"no-sidebar","site-content-layout":"","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":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","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":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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