{"id":370,"date":"2024-04-24T16:21:41","date_gmt":"2024-04-24T16:21:41","guid":{"rendered":"http:\/\/annualreport.edqm.eu\/?page_id=370"},"modified":"2024-06-10T20:40:06","modified_gmt":"2024-06-10T20:40:06","slug":"reference-standards","status":"publish","type":"page","link":"https:\/\/annualreport2023.edqm.eu\/fr\/reference-standards\/","title":{"rendered":"\u00c9talons de r\u00e9f\u00e9rence"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"370\" class=\"elementor elementor-370\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2f95b880 elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle elementor-invisible\" data-id=\"2f95b880\" 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<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-380f7e76\" data-id=\"380f7e76\" 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-280dea8 elementor-widget elementor-widget-heading\" data-id=\"280dea8\" 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-69ace99d elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"69ace99d\" 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-71b65af6\" data-id=\"71b65af6\" 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-1a498e80 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1a498e80\" 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-12e6d7c1\" data-id=\"12e6d7c1\" 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-482f239 elementor-widget elementor-widget-heading\" data-id=\"482f239\" 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\">\u00c9talons de r\u00e9f\u00e9rence<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6c67758 elementor-widget elementor-widget-text-editor\" data-id=\"6c67758\" 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><strong>L\u2019EDQM assure la mise \u00e0 disposition des \u00e9talons de r\u00e9f\u00e9rence (ER) de la Ph. Eur. et contribue ainsi \u00e0 maintenir la disponibilit\u00e9 de m\u00e9dicaments de qualit\u00e9 en Europe et au-del\u00e0. Les ER officiels font partie int\u00e9grante de la Ph. Eur. Ils sont, en effet, utilis\u00e9s en compl\u00e9ment de ses normes, dans le cadre des proc\u00e9dures analytiques d\u00e9crites dans les monographies.<\/strong><\/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-39d445c0\" data-id=\"39d445c0\" 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-1ba36431 elementor-widget elementor-widget-image\" data-id=\"1ba36431\" 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=\"850\" height=\"671\" src=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/02-RS-EN.jpg\" class=\"attachment-full size-full wp-image-842\" alt=\"\" srcset=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/02-RS-EN.jpg 850w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/02-RS-EN-300x237.jpg 300w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/02-RS-EN-768x606.jpg 768w\" sizes=\"(max-width: 850px) 100vw, 850px\" \/>\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-6d4de0a elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"6d4de0a\" 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-b8711f9\" data-id=\"b8711f9\" 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-ddf966f elementor-widget elementor-widget-heading\" data-id=\"ddf966f\" 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\">Activit\u00e9s<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-439b29f elementor-widget elementor-widget-text-editor\" data-id=\"439b29f\" 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>Le catalogue des ER de la Ph. Eur. en contient actuellement 3 171. En 2023, la Commission europ\u00e9enne de Pharmacop\u00e9e (EPC) a adopt\u00e9 235 ER, sur la base des rapports d\u2019\u00e9tablissement soumis par le Laboratoire de l\u2019EDQM.<\/p><p>L\u2019EDQM distribue ses ER dans le monde entier et son catalogue \u00e9volue constamment : de nouveaux \u00e9talons sont r\u00e9guli\u00e8rement \u00e9tablis, en compl\u00e9ment des nouveaux textes et des textes r\u00e9vis\u00e9s de la Ph. Eur. ou en remplacement des lots existants lorsque les stocks s\u2019\u00e9puisent. La gestion globale du cycle de vie des ER suppose un large \u00e9ventail de t\u00e2ches : de l\u2019approvisionnement en substances candidates, leur caract\u00e9risation et leur \u00e9tablissement, \u00e0 la fabrication, au contr\u00f4le qualit\u00e9, \u00e0 l\u2019assurance qualit\u00e9, \u00e0 la lib\u00e9ration, \u00e0 la distribution et au monitorage des lots.<\/p><p>En 2023, l\u2019EDQM a distribu\u00e9 les ER de la Ph. Eur., en direct, dans 135 pays (contre 131 en 2022).<\/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-377782e elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"377782e\" 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-9257dff\" data-id=\"9257dff\" 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-1133056 no-margin elementor-widget elementor-widget-heading\" data-id=\"1133056\" 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\">Programmes conjoints<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-51bdb81 elementor-widget elementor-widget-text-editor\" data-id=\"51bdb81\" 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>Les \u00e9tudes collaboratives internationales (cofinanc\u00e9es par l\u2019Union europ\u00e9enne) r\u00e9alis\u00e9es en 2023 dans le cadre du Programme de standardisation biologique (BSP) ont abouti \u00e0 l\u2019adoption de quatre lots de remplacement d\u2019\u00e9talons de r\u00e9f\u00e9rence :<\/p><ul><li>\u00e9tablissement de lots de remplacement pour l\u2019Immunoglobuline PBR (BSP150) ;<\/li><li>\u00e9tablissement d\u2019un lot de remplacement pour l\u2019\u00c9rythropo\u00ef\u00e9tine pour essais physicochimiques SCR (BSP159) ;<\/li><li>\u00e9tablissement d\u2019un lot de remplacement pour le R\u00e9actif de capture pour dosage ELISA du virus de l\u2019h\u00e9patite A RBR (BSP165) ;<\/li><li>\u00e9tablissement d\u2019un lot de remplacement pour l\u2019Activateur de pr\u00e9kallikr\u00e9ine dans l\u2019albumine PBR (BSP167).<\/li><\/ul>\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-fbaadd6 elementor-widget elementor-widget-image\" data-id=\"fbaadd6\" 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 decoding=\"async\" width=\"870\" height=\"165\" src=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/04\/Funded-EU-and-COE-Implemented-COE-quadri-en.png\" class=\"attachment-full size-full wp-image-357\" alt=\"\" srcset=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/04\/Funded-EU-and-COE-Implemented-COE-quadri-en.png 870w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/04\/Funded-EU-and-COE-Implemented-COE-quadri-en-300x57.png 300w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/04\/Funded-EU-and-COE-Implemented-COE-quadri-en-768x146.png 768w\" sizes=\"(max-width: 870px) 100vw, 870px\" \/>\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-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\">Coop\u00e9ration internationale<\/h3>\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-440e462 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"440e462\" 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-c23921d\" data-id=\"c23921d\" 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-969cc15 elementor-widget elementor-widget-heading\" data-id=\"969cc15\" 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\">Collaboration avec l\u2019OMS<\/h4>\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-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>L\u2019EDQM est responsable de l\u2019\u00e9tablissement, de la fabrication, du monitorage et de la distribution des substances chimiques de r\u00e9f\u00e9rence internationales (SCRI) de l\u2019OMS. Le catalogue des SCRI en contient actuellement 212. Les SCRI sont n\u00e9cessaires \u00e0 l\u2019application des textes de la Pharmacop\u00e9e internationale, publi\u00e9e et tenue \u00e0 jour par le Comit\u00e9 d\u2019experts des sp\u00e9cifications relatives aux pr\u00e9parations pharmaceutiques (ECSPP) de l\u2019OMS.<\/p><p>En 2023, l\u2019ECSPP a adopt\u00e9 deux nouvelles SCRI, sur la base des rapports d\u2019\u00e9tablissement soumis par le Laboratoire de l\u2019EDQM. En outre, neuf rapports ont \u00e9t\u00e9 publi\u00e9s sur la v\u00e9rification de la conformit\u00e9 d\u2019ER candidats (et\/ou des strat\u00e9gies d\u2019\u00e9tablissement correspondantes) et deux autres sur des \u00e9tudes de faisabilit\u00e9 relatives \u00e0 la production par des techniques de fabrication avanc\u00e9es.<\/p><p>L\u2019EDQM est \u00e9galement responsable de l\u2019\u00e9tablissement, de la fabrication, du stockage et de la distribution des \u00e9talons internationaux d\u2019antibiotiques (ISA) de l\u2019OMS, qui jouent un r\u00f4le essentiel pour la standardisation et le contr\u00f4le qualit\u00e9 des antibiotiques (substances actives et m\u00e9dicaments). Le catalogue des ISA en contient actuellement 24.<\/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-15d70f1\" data-id=\"15d70f1\" 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-6650c46 elementor-widget elementor-widget-heading\" data-id=\"6650c46\" 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\">Collaboration avec l\u2019ISO<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0340d0e elementor-widget elementor-widget-text-editor\" data-id=\"0340d0e\" 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>L\u2019EDQM a poursuivi sa participation, comme organisme de liaison, aux activit\u00e9s du Comit\u00e9 technique ISO\/TC 334 Mat\u00e9riaux de r\u00e9f\u00e9rence.<\/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-7be9919 elementor-widget elementor-widget-heading\" data-id=\"7be9919\" 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\">Collaboration avec les laboratoires nationaux<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-857755b elementor-widget elementor-widget-text-editor\" data-id=\"857755b\" 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>Le Laboratoire de l\u2019EDQM peut compter sur le soutien de plusieurs laboratoires officiels lorsque des \u00e9tudes collaboratives sont n\u00e9cessaires pour \u00e9tablir des \u00e9talons de r\u00e9f\u00e9rence de la Ph. Eur. En 2023, 27 laboratoires officiels de contr\u00f4le des m\u00e9dicaments, repr\u00e9sentant 22 pays, ont pris part \u00e0 ces \u00e9tudes d\u2019\u00e9tablissement d\u2019ER.<\/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-9b6c4fd elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"9b6c4fd\" 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-54b28f4\" data-id=\"54b28f4\" 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-465d531 elementor-widget elementor-widget-heading\" data-id=\"465d531\" 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, bases de donn\u00e9es et site web<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a4880ae elementor-widget elementor-widget-text-editor\" data-id=\"a4880ae\" 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\">Tout au long de l\u2019ann\u00e9e 2023, l\u2019EDQM a continu\u00e9 de proposer \u00e0 la consultation et d\u2019actualiser sa base de donn\u00e9es en ligne (<span style=\"text-decoration: underline\"><a href=\"https:\/\/crs.edqm.eu\" target=\"_blank\" rel=\"noopener\">https:\/\/crs.edqm.eu<\/a><\/span>) r\u00e9pertoriant l\u2019ensemble des \u00e9talons de r\u00e9f\u00e9rence officiellement en cours de validit\u00e9 pour les usages prescrits dans les monographies de la Ph. Eur. Elle permet de rechercher des ER par code, par nom, par num\u00e9ro de monographie ou par num\u00e9ro CAS. De plus, les d\u00e9clarations de validit\u00e9 de lot sont \u00e0 la disposition des utilisateurs et utilisatrices pour prouver la validit\u00e9 des lots d\u2019ER au moment de leur emploi. Des fiches de donn\u00e9es de s\u00e9curit\u00e9, d\u00e9clarations de donn\u00e9es de s\u00e9curit\u00e9 biologique et notices sont, par ailleurs, t\u00e9l\u00e9chargeables depuis cette base de donn\u00e9es.<\/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\/the-european-pharmacopoeia\/\">\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 elementor-invisible\" data-id=\"80f43ff\" data-element_type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInRight&quot;,&quot;animation_mobile&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-870764a elementor-align-right elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"870764a\" 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\/certification-of-suitability\/\">\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-right\" viewbox=\"0 0 448 512\" 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 Reference standards The EDQM ensures the supply of Ph. Eur. reference standards (RSs) to help safeguard the availability of quality medicines in Europe and beyond. Official RSs are an integral part of the Ph.\u00a0Eur. since they are used in conjunction with Ph.\u00a0Eur. documentary standards to perform the analytical procedures described [&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-370","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>Reference standards | 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\/reference-standards\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Reference standards | Quality &amp; use of medicines - EDQM\" \/>\n<meta property=\"og:description\" content=\"Quality &#038; use of medicines Reference standards The EDQM ensures the supply of Ph. 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