{"id":411,"date":"2024-04-25T12:03:45","date_gmt":"2024-04-25T12:03:45","guid":{"rendered":"http:\/\/annualreport.edqm.eu\/?page_id=411"},"modified":"2024-06-10T20:42:40","modified_gmt":"2024-06-10T20:42:40","slug":"response-to-nitrosamine-contamination","status":"publish","type":"page","link":"https:\/\/annualreport2023.edqm.eu\/fr\/response-to-nitrosamine-contamination\/","title":{"rendered":"Contamination par des nitrosamines : les r\u00e9ponses apport\u00e9es par l\u2019EDQM"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"411\" class=\"elementor elementor-411\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3ef1ea16 elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle elementor-invisible\" data-id=\"3ef1ea16\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInDown&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\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-5f047a9a\" data-id=\"5f047a9a\" data-element_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-f76bd81 elementor-widget elementor-widget-heading\" data-id=\"f76bd81\" data-element_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\">Quality &amp; use of medicines<\/h2>\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-58e1eaf5 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"58e1eaf5\" data-element_type=\"section\" id=\"europeanpharmacopoeia\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&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-1cad4e1\" data-id=\"1cad4e1\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-6f87a502 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6f87a502\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-38110ea7\" data-id=\"38110ea7\" data-element_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-36ca8a84 elementor-widget elementor-widget-heading\" data-id=\"36ca8a84\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Contamination par des nitrosamines : les r\u00e9ponses apport\u00e9es par l\u2019EDQM<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6878b2d2 elementor-widget elementor-widget-text-editor\" data-id=\"6878b2d2\" data-element_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\"><b>Certains types de nitrosamines, comme la <em>N<\/em>-nitrosodi\u00e9thylamine (NDEA) et la <em>N<\/em>-nitrosodim\u00e9thylamine (NDMA), sont class\u00e9es comme carcinog\u00e8nes probables pour l\u2019\u00eatre humain et, conform\u00e9ment aux dispositions r\u00e9glementaires en vigueur, ne sont tol\u00e9r\u00e9es qu\u2019\u00e0 tr\u00e8s faible teneur. Depuis leur d\u00e9tection dans plusieurs substances actives en 2018, l\u2019EDQM agit \u00e0 plusieurs niveaux pour r\u00e9pondre \u00e0 ce probl\u00e8me, en coop\u00e9rant continuellement avec les autorit\u00e9s r\u00e9glementaires, tant \u00e0 l\u2019\u00e9chelle de l\u2019UE qu\u2019\u00e0 l\u2019\u00e9chelle internationale. Ces initiatives sont d\u00e9taill\u00e9es sur la <span style=\"text-decoration: underline\"><a href=\"https:\/\/www.edqm.eu\/fr\/n-nitrosamine-contamination-in-brief\" target=\"_blank\" rel=\"noopener\">page web de l\u2019EDQM consacr\u00e9e aux nitrosamines<\/a><\/span>.<\/b><\/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<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-2331a510\" data-id=\"2331a510\" data-element_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-295236f5 elementor-widget elementor-widget-image\" data-id=\"295236f5\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"533\" src=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Dosage-Image.jpg\" class=\"attachment-full size-full wp-image-1462\" alt=\"\" srcset=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Dosage-Image.jpg 800w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Dosage-Image-300x200.jpg 300w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Dosage-Image-768x512.jpg 768w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Dosage-Image-18x12.jpg 18w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\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-ed3aafc elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"ed3aafc\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&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-cf68d1f\" data-id=\"cf68d1f\" data-element_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-b17e6b2 elementor-widget elementor-widget-heading\" data-id=\"b17e6b2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Strat\u00e9gie de la Ph. Eur.<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6f124e2 elementor-widget elementor-widget-text-editor\" data-id=\"6f124e2\" data-element_type=\"widget\" data-no-translation=\"\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>.elementor-element-6f124e2{display:none !important}<\/style>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-45a1e69 elementor-widget elementor-widget-text-editor\" data-id=\"45a1e69\" data-element_type=\"widget\" data-no-translation=\"\" 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\">En 2023, la Commission europ\u00e9enne de Pharmacop\u00e9e (EPC) a poursuivi le d\u00e9ploiement de son plan d\u2019action complet contre les nitrosamines, apr\u00e8s avoir adopt\u00e9 la version r\u00e9vis\u00e9e des monographies g\u00e9n\u00e9rales\u00a0<em>Substances pour usage pharmaceutique (2034)<\/em>\u00a0et\u00a0<em>Pr\u00e9parations pharmaceutiques (2619)<\/em>, textes fondamentaux et juridiquement contraignants dans lesquels figure d\u00e9sormais un paragraphe expliquant l\u2019approche adopt\u00e9e par la Ph. Eur. concernant les impuret\u00e9s\u00a0<em>N<\/em>-nitrosamine. Celle-ci a \u00e9t\u00e9 d\u00e9finie sur la base des commentaires re\u00e7us \u00e0 propos de ces monographies lors de la derni\u00e8re enqu\u00eate publique\u00a0<em>Pharmeuropa<\/em>\u00a0et des r\u00e9centes observations \u00e9manant de groupes du r\u00e9seau HMA (r\u00e9seau des responsables des agences du m\u00e9dicament) et de l\u2019EMA (Agence europ\u00e9enne des m\u00e9dicaments), ainsi que des ANC des \u00c9tats membres de la Ph. Eur. hors UE.<\/p><p class=\"translation-block\">Le nouveau paragraphe, ajout\u00e9 dans la section Production de ces deux textes majeurs, stipule que les fabricants sont d\u00e9sormais cens\u00e9s \u00e9valuer le risque de formation de\u00a0<em>N<\/em>-nitrosamines et de contamination par des\u00a0<em>N<\/em>-nitrosamines pouvant survenir tout au long du proc\u00e9d\u00e9 de fabrication et au cours de la conservation\u00a0<em>(2034)<\/em>\u00a0ou pendant toute la dur\u00e9e de conservation\u00a0<em>(2619)<\/em>. Si le risque est confirm\u00e9, il convient que les fabricants r\u00e9duisent autant que possible le risque de pr\u00e9sence de\u00a0<em>N<\/em>-nitrosamines \u2013 en modifiant, par exemple, leur proc\u00e9d\u00e9 de fabrication \u2013 et mettent en \u0153uvre une strat\u00e9gie de contr\u00f4le pour les d\u00e9tecter et les \u00e9liminer.<\/p><p>Les monographies r\u00e9vis\u00e9es ont \u00e9t\u00e9 publi\u00e9es dans le Suppl\u00e9ment 11.3 de la Ph. Eur. (juillet 2023), avec une date de mise en application au 1<sup>er<\/sup> janvier 2024.<\/p><p>Selon le plan d\u2019action, l\u2019\u00e9tape suivante consistait \u00e0 d\u00e9terminer la mani\u00e8re d\u2019aborder la question du contr\u00f4le des nitrosamines dans les monographies sp\u00e9cifiques.<\/p><p class=\"translation-block\">Lors de sa 177<sup>e<\/sup> session (novembre 2023), l\u2019EPC a approuv\u00e9 la strat\u00e9gie relative aux impuret\u00e9s <em>N<\/em>-nitrosamine dans les monographies sp\u00e9cifiques (d\u00e9taill\u00e9e ci-apr\u00e8s), apr\u00e8s avoir consult\u00e9 ses parties int\u00e9ress\u00e9es au cours de l\u2019ann\u00e9e.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-f3ffb7d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f3ffb7d\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-6a632f0\" data-id=\"6a632f0\" data-element_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-795277c elementor-widget elementor-widget-heading\" data-id=\"795277c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Concernant les monographies de substances actives<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5038f28 elementor-widget elementor-widget-text-editor\" data-id=\"5038f28\" data-element_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\">L\u2019exigence g\u00e9n\u00e9rale relative aux impuret\u00e9s <em>N<\/em>-nitrosamine qui figure dans la monographie g\u00e9n\u00e9rale <em>2034<\/em> r\u00e9vis\u00e9e s\u2019applique \u00e0 toutes les substances pour usage pharmaceutique entrant dans le champ d\u2019application du texte. L\u2019EPC a donc recommand\u00e9 de supprimer les libell\u00e9s existants au sujet de ces impuret\u00e9s de la section Production des monographies sp\u00e9cifiques de substances actives et de ne plus inclure, \u00e0 l\u2019avenir, ce type de d\u00e9claration dans les nouvelles monographies.<\/p><p class=\"translation-block\">L\u2019EPC a ainsi d\u00e9fini des r\u00e8gles claires concernant l\u2019ajout d\u2019une sp\u00e9cification relative aux impuret\u00e9s <em>N<\/em>-nitrosamine dans la section Essai des monographies de substances actives. Cet ajout ne sera fait que si la <em>N<\/em>-nitrosamine consid\u00e9r\u00e9e est une impuret\u00e9 li\u00e9e au proc\u00e9d\u00e9, c.-\u00e0-d. g\u00e9n\u00e9r\u00e9e pendant la synth\u00e8se de la substance, ou une impuret\u00e9 de d\u00e9gradation r\u00e9sultant de la conservation de la substance. L\u2019essai et la limite seront inclus dans une monographie sp\u00e9cifique si cette impuret\u00e9 a \u00e9t\u00e9 d\u00e9tect\u00e9e dans plusieurs sources de la substance et une fois une limite approuv\u00e9e par les Autorit\u00e9s comp\u00e9tentes.<\/p><p class=\"translation-block\">L\u2019EPC a, en outre, d\u00e9cid\u00e9 de ne pas aborder, dans les monographies sp\u00e9cifiques, les types de contamination potentielle par des <em>N<\/em>-nitrosamines \u00e9num\u00e9r\u00e9s ci-apr\u00e8s, car ils sont consid\u00e9r\u00e9s comme couverts par ailleurs :<\/p><ul><li>les impuret\u00e9s r\u00e9sultant des pratiques de fabrication pendant la synth\u00e8se de la substance active (mati\u00e8res valoris\u00e9es ou recycl\u00e9es, contamination crois\u00e9e) ;<\/li><li>les impuret\u00e9s potentiellement g\u00e9n\u00e9r\u00e9es pendant la fabrication ou la conservation du m\u00e9dicament ;<\/li><li>le risque de transformation future en une nitrosamine (p. ex. amines secondaires).<\/li><\/ul>\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-inner-column elementor-element elementor-element-2f3b760\" data-id=\"2f3b760\" data-element_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-990e51c elementor-widget elementor-widget-heading\" data-id=\"990e51c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Concernant les monographies de m\u00e9dicaments<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cf0184f elementor-widget elementor-widget-text-editor\" data-id=\"cf0184f\" data-element_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\">Pour ce qui est des monographies de m\u00e9dicaments, l\u2019EPC a convenu qu\u2019il n\u2019\u00e9tait pas appropri\u00e9 d\u2019introduire une sp\u00e9cification dans la section Essai ni une d\u00e9claration dans la section Production, sauf dans certains cas sp\u00e9cifiques et justifi\u00e9s, car le risque de formation de <em>N<\/em>-nitrosamines d\u00e9pend, dans une vaste mesure, de la composition du m\u00e9dicament et de ses conditions de fabrication. Elle consid\u00e8re, en effet, que la section <em>N<\/em>-nitrosamines de la monographie g\u00e9n\u00e9rale <em>Pr\u00e9parations pharmaceutiques (2619)<\/em> couvre totalement ce risque.<\/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\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-e4fff5b elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"e4fff5b\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&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-50318a1\" data-id=\"50318a1\" data-element_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-dfd8eef elementor-widget elementor-widget-heading\" data-id=\"dfd8eef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Actions relatives aux CEP<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-04bcf6d elementor-widget elementor-widget-text-editor\" data-id=\"04bcf6d\" data-element_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\">Fin 2023, le Service de la Certification des substances de l\u2019EDQM avait examin\u00e9 toutes les demandes dans lesquelles un risque de pr\u00e9sence de <em>N<\/em>-nitrosamines avait \u00e9t\u00e9 identifi\u00e9. Toutefois, les titulaires de CEP tiennent l\u2019EDQM r\u00e9guli\u00e8rement inform\u00e9e de tout nouveau risque de formation de <em>N<\/em>-nitrosamines ou en cas de d\u00e9tection de telles substances, g\u00e9n\u00e9ralement des impuret\u00e9s nitrosamine d\u00e9riv\u00e9es de la substance active (NDSRI), dans leurs substances actives. Des voies de communication r\u00e9guli\u00e8re sont en place pour assurer la transmission de ce type d\u2019informations.<\/p><p class=\"translation-block\">Une \u00e9valuation de la pr\u00e9sence potentielle de <em>N<\/em>-nitrosamines est r\u00e9alis\u00e9e en routine pour toutes les nouvelles demandes de CEP, au moment du renouvellement des CEP et pour les r\u00e9visions susceptibles d\u2019influer sur le degr\u00e9 de risque, sur la base des donn\u00e9es que les demandeurs sont tenus de soumettre.<\/p><p class=\"translation-block\">En juillet 2023, l\u2019EDQM a commenc\u00e9 \u00e0 mettre en application les nouvelles approches scientifiques de cat\u00e9gorisation des <em>N-<\/em>nitrosamines, ainsi que les doses admissibles (DA) \u00e9tablies. Il convient d\u00e9sormais d\u2019utiliser l\u2019approche de cat\u00e9gorisation de l\u2019activit\u00e9 canc\u00e9rog\u00e8ne (CPCA, pour \u00ab <em>Carcinogenic Potency Categorisation Approach<\/em> \u00bb) et le test d\u2019Ames am\u00e9lior\u00e9 (EAT, pour \u00ab <em>enhanced Ames test<\/em> \u00bb) qui sont d\u00e9crits dans les questions-r\u00e9ponses de l\u2019EMA pour d\u00e9terminer la cat\u00e9gorie d\u2019activit\u00e9 et les DA correspondantes, dont il faut tenir compte dans l\u2019\u00e9valuation des risques et dans la strat\u00e9gie de contr\u00f4le adopt\u00e9e.<\/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-8aa3de0 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"8aa3de0\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&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-6904f0e\" data-id=\"6904f0e\" data-element_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-3a8933b elementor-widget elementor-widget-heading\" data-id=\"3a8933b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Collaboration avec les partenaires europ\u00e9ens et internationaux<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3946e34 elementor-widget elementor-widget-text-editor\" data-id=\"3946e34\" data-element_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>Sur cette question, l\u2019EDQM maintient une coop\u00e9ration constante avec les autorit\u00e9s r\u00e9glementaires \u00e0 l\u2019\u00e9chelle nationale, de l\u2019UE et internationale, notamment par le biais du NISG \u2013 groupe strat\u00e9gique international sur les nitrosamines \u2013 et de son groupe de travail technique (NITWG), et continuera \u00e0 le faire pour assurer une approche coordonn\u00e9e et harmonis\u00e9e de la prise de d\u00e9cisions et de leur mise en \u0153uvre.<\/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-f769513 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"f769513\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&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-86ee924\" data-id=\"86ee924\" data-element_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-66a1242 elementor-widget elementor-widget-heading\" data-id=\"66a1242\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Strat\u00e9gies d\u2019\u00e9chantillonnage et contr\u00f4le des m\u00e9thodes en collaboration avec les OMCL<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f642bd elementor-widget elementor-widget-text-editor\" data-id=\"0f642bd\" data-element_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>Depuis mi-2018, les membres du GEON participent \u00e0 diff\u00e9rentes activit\u00e9s relatives \u00e0 la d\u00e9tection des nitrosamines dans les substances actives et les m\u00e9dicaments. Un groupe OMCL de contr\u00f4le \u00e9tabli \u00e0 ces fins s\u2019est r\u00e9uni 16 fois depuis lors et a \u00e9tendu son champ d\u2019activit\u00e9 au-del\u00e0 de la cat\u00e9gorie des nitrosamines (comprenant les NDSRI) afin de couvrir \u00e9galement le dosage des impuret\u00e9s mutag\u00e8nes pr\u00e9sentes \u00e0 l\u2019\u00e9tat de traces (impuret\u00e9s azotur\u00e9es dans les sartans \u00e0 cycle t\u00e9trazole, par exemple).<\/p><p>Le groupe OMCL de contr\u00f4le relatif aux contaminants mutag\u00e8nes s\u2019est r\u00e9uni une fois, en octobre 2023, pour partager les derni\u00e8res \u00e9volutions concernant les approches examin\u00e9es par les autorit\u00e9s r\u00e9glementaires internationales dans l\u2019objectif de d\u00e9finir des limites d\u2019acceptation pour les NDSRI, d\u2019examiner les activit\u00e9s actuelles et planifi\u00e9es \u00e0 l\u2019\u00e9chelle nationale en mati\u00e8re d\u2019essais au sein du r\u00e9seau et de d\u00e9terminer les futures strat\u00e9gies de contr\u00f4le.<\/p><p>Un programme de formation pratique portant sur le contr\u00f4le des nitrosamines, destin\u00e9 aux OMCL, a \u00e9t\u00e9 organis\u00e9 par l\u2019OMCL suisse (Swissmedic), \u00e0 Berne. Dans le cadre du programme de coop\u00e9ration avec l\u2019EMA au sujet de l\u2019\u00e9chantillonnage et du contr\u00f4le des produits autoris\u00e9s selon la proc\u00e9dure centralis\u00e9e (CAP), un programme d\u2019essai sp\u00e9cial consacr\u00e9 aux nitrosamines sera men\u00e9 prochainement pour les CAP.<\/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-2a2016c elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"2a2016c\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&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-510aecb\" data-id=\"510aecb\" data-element_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-fcb4630 elementor-widget elementor-widget-heading\" data-id=\"fcb4630\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Publications<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9e00106 elementor-widget elementor-widget-text-editor\" data-id=\"9e00106\" data-element_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\">Trois OMCL et l\u2019EDQM, ainsi que des laboratoires d\u2019Australie, du Canada et des membres du groupe de la FDA des \u00c9tats-Unis, ont cor\u00e9dig\u00e9 un article scientifique intitul\u00e9 \u00ab Performance Characteristics of Mass Spectrometry-Based Analytical Procedures for the Quantitation of Nitrosamines in Pharmaceuticals: Insights from an inter-laboratory Study \u00bb (Yang <em>et al.<\/em>, 2023), publi\u00e9 dans la revue <a style=\"color: #ffffff\" href=\"https:\/\/doi.org\/10.1016\/j.xphs.2023.07.022\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline\"><em>Journal of Pharmaceutical Science<\/em><\/a><\/span>.<\/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-32556c1 elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"32556c1\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&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-32ab12c elementor-invisible\" data-id=\"32ab12c\" data-element_type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInLeft&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-2bd603c elementor-widget elementor-widget-button\" data-id=\"2bd603c\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/annualreport2023.edqm.eu\/fr\/european-network-of-official-medicines-control-laboratories\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-left\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M257.5 445.1l-22.2 22.2c-9.4 9.4-24.6 9.4-33.9 0L7 273c-9.4-9.4-9.4-24.6 0-33.9L201.4 44.7c9.4-9.4 24.6-9.4 33.9 0l22.2 22.2c9.5 9.5 9.3 25-.4 34.3L136.6 216H424c13.3 0 24 10.7 24 24v32c0 13.3-10.7 24-24 24H136.6l120.5 114.8c9.8 9.3 10 24.8.4 34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Page pr\u00e9c\u00e9dente<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-80f43ff 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512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Page suivante<\/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},"excerpt":{"rendered":"<p>Quality &#038; use of medicines The EDQM\u2019s response to nitrosamine contamination Certain types of nitrosamines, such as N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA), are known as possible carcinogens for humans and only very low amounts are acceptable according to current regulatory requirements. Since their detection in a number of active substances in 2018, the EDQM has [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"","ocean_second_sidebar":"","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"","ocean_custom_header_template":"","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"","ocean_menu_typo_font_family":"","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"","footnotes":""},"class_list":["post-411","page","type-page","status-publish","hentry","entry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The EDQM\u2019s response to nitrosamine contamination | Quality &amp; use of medicines - EDQM<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/annualreport2023.edqm.eu\/fr\/response-to-nitrosamine-contamination\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The EDQM\u2019s response to nitrosamine contamination | Quality &amp; use of medicines - EDQM\" \/>\n<meta property=\"og:description\" content=\"Quality &#038; use of medicines The EDQM\u2019s response to nitrosamine contamination Certain types of nitrosamines, such as N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA), are known as possible carcinogens for humans and only very low amounts are acceptable according to current regulatory requirements. 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