{"id":370,"date":"2024-04-24T16:21:41","date_gmt":"2024-04-24T16:21:41","guid":{"rendered":"http:\/\/annualreport-2025.guerillainteractive.co.uk\/?page_id=370"},"modified":"2025-07-24T13:07:58","modified_gmt":"2025-07-24T13:07:58","slug":"etalons-de-reference","status":"publish","type":"page","link":"https:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/etalons-de-reference\/","title":{"rendered":"\u00c9talons de r\u00e9f\u00e9rence"},"content":{"rendered":"
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Qualit\u00e9 et utilisation des m\u00e9dicaments<\/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
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\u00c9talons de r\u00e9f\u00e9rence<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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L\u2019EDQM assure la mise \u00e0 disposition des \u00e9talons de r\u00e9f\u00e9rence officiels de la Pharmacop\u00e9e Europ\u00e9enne et contribue ainsi \u00e0 maintenir la qualit\u00e9 et la disponibilit\u00e9 des m\u00e9dicaments en Europe et au-del\u00e0. Ces \u00e9talons de r\u00e9f\u00e9rence sont indispensables \u00e0 l\u2019application des essais de contr\u00f4le qualit\u00e9 prescrits par la Ph.\u00a0Eur. Les laboratoires charg\u00e9s du contr\u00f4le qualit\u00e9 des m\u00e9dicaments, par exemple, se servent de ces \u00e9talons officiels pour r\u00e9aliser les proc\u00e9dures analytiques d\u00e9crites dans les monographies.<\/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

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Activit\u00e9s<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Le vaste catalogue des \u00e9talons de r\u00e9f\u00e9rence de la Ph.\u00a0Eur. contient actuellement 3\u00a0220\u00a0\u00e9talons de r\u00e9f\u00e9rence utilis\u00e9s pour assurer la qualit\u00e9 des m\u00e9dicaments. En\u00a02024, l\u2019EPC a adopt\u00e9 236\u00a0\u00e9talons de r\u00e9f\u00e9rence, sur la base des rapports d\u2019\u00e9tablissement r\u00e9dig\u00e9s par le Laboratoire de l\u2019EDQM.<\/p>

L\u2019EDQM distribue ses \u00e9talons de r\u00e9f\u00e9rence dans le monde entier. Son catalogue ne cesse d\u2019\u00e9voluer pour r\u00e9pondre aux exigences des textes (nouveaux ou r\u00e9vis\u00e9s) de la Ph.\u00a0Eur., et les \u00e9talons existants sont remplac\u00e9s lorsque les stocks sont \u00e9puis\u00e9s, en fonction des besoins. La gestion de ce catalogue n\u00e9cessite une approche globale, impliquant des t\u00e2ches vari\u00e9es\u00a0: l\u2019approvisionnement en substances candidates, la caract\u00e9risation et l\u2019\u00e9tablissement des \u00e9talons, mais aussi la fabrication, le contr\u00f4le qualit\u00e9, l\u2019assurance qualit\u00e9 et la lib\u00e9ration des lots. La distribution et le monitorage permanent de ces \u00e9talons sont essentiels \u00e0 la garantie de leur pertinence et de leur fiabilit\u00e9.<\/p>

En\u00a02024, les \u00e9talons de r\u00e9f\u00e9rence de la Ph.\u00a0Eur. ont \u00e9t\u00e9 distribu\u00e9s directement \u00e0 127\u00a0pays, ce qui illustre l\u2019importance mondiale des travaux de l\u2019EDQM et leur impact sur la sant\u00e9 publique.<\/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

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Programmes conjoints<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Les activit\u00e9s du Programme de standardisation biologique (cofinanc\u00e9 par l\u2019Union europ\u00e9enne) ont conduit \u00e0 l\u2019adoption d\u2019un nouvel \u00e9talon de r\u00e9f\u00e9rence (lot\u00a01 de Golimumab\u00a0PBR) et de deux lots de remplacement (lot\u00a02 d\u2019Immunoglobuline humaine anti-D\u00a0PBR et lot\u00a06 d\u2019H\u00e9parine de basse masse mol\u00e9culaire pour \u00e9talonnage\u00a0SCR) sur la base des \u00e9tudes\u00a0BSP164, BSP176 et BSP121, respectivement.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Coop\u00e9ration internationale<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Collaboration avec l\u2019OMS<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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 211. Utilis\u00e9es dans le monde entier, les SCRI sont n\u00e9cessaires \u00e0 l\u2019application des textes de la Pharmacop\u00e9e internationale, publi\u00e9e et tenue \u00e0 jour par l\u2019OMS.<\/p>

En\u00a02024, le comit\u00e9 d\u2019experts des sp\u00e9cifications relatives aux pr\u00e9parations pharmaceutiques de l\u2019OMS (ECSPP) a adopt\u00e9 huit\u00a0nouvelles SCRI et quatre\u00a0lots de remplacement de SCRI sur la base de rapports d\u2019\u00e9tablissement soumis par le Laboratoire de l\u2019EDQM. En outre, il a publi\u00e9 deux rapports sur la v\u00e9rification de l\u2019ad\u00e9quation d\u2019\u00e9talons de r\u00e9f\u00e9rence candidats (et\/ou des strat\u00e9gies d\u2019\u00e9tablissement correspondantes), trois sur des \u00e9tudes de faisabilit\u00e9 de production par des techniques de fabrication avanc\u00e9es, trois sur l\u2019extension du champ d\u2019application de SCRI existantes et, enfin, un sur la d\u00e9termination d\u2019une valeur d\u2019absorptivit\u00e9 sp\u00e9cifique dans le cadre de la r\u00e9vision d\u2019une monographie.<\/p>

L\u2019EDQM est \u00e9galement responsable de la fabrication, de l\u2019\u00e9tablissement, du stockage et de la distribution des \u00e9talons internationaux d\u2019antibiotiques (ISA) de l\u2019OMS, qui jouent un r\u00f4le essentiel dans la standardisation et le contr\u00f4le qualit\u00e9 des antibiotiques (substances actives et m\u00e9dicaments). Le catalogue des ISA en contient actuellement 23.<\/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

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Collaboration avec l\u2019ISO<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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L\u2019EDQM a poursuivi sa participation, comme organisme de liaison, aux activit\u00e9s du Comit\u00e9 technique ISO\/TC\u00a0334 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

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Collaboration avec des laboratoires nationaux<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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.\u00a0Eur. En\u00a02024, 28\u00a0OMCL, repr\u00e9sentant 19\u00a0pays, ont pris part \u00e0 ces \u00e9tudes.<\/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

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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
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Tout au long de l\u2019ann\u00e9e\u00a02024, l\u2019EDQM a continu\u00e9 de proposer \u00e0 la consultation sa base de donn\u00e9es en ligne (https:\/\/crs.edqm.eu<\/a>) 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.\u00a0Eur. Actualis\u00e9e r\u00e9guli\u00e8rement, elle permet de rechercher des ER par code, par nom, par num\u00e9ro de monographie ou par num\u00e9ro\u00a0CAS. De plus, elle contient les d\u00e9clarations de validit\u00e9 de lot, auxquelles les utilisateurs et utilisatrices peuvent recourir pour prouver la validit\u00e9 des lots d\u2019ER au moment de leur emploi. Des fiches de donn\u00e9es de s\u00e9curit\u00e9, des d\u00e9clarations de donn\u00e9es de s\u00e9curit\u00e9 biologique et des 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

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Quality & use of medicines Qualit\u00e9 et utilisation des m\u00e9dicaments Reference standards The EDQM ensures the supply of official European Pharmacopoeia reference standards to help safeguard the quality and availability of medicines in Europe and beyond. Official reference standards are essential for the application of the quality control tests described in Ph.\u00a0Eur. texts. Quality and […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"ocean_front_end_style_editor":"no","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":"\nReference standards | Quality & 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:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/etalons-de-reference\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Reference standards | Quality & use of medicines - EDQM\" \/>\n<meta property=\"og:description\" content=\"Quality & use of medicines Qualit\u00e9 et utilisation des m\u00e9dicaments Reference standards The EDQM ensures the supply of official European Pharmacopoeia reference standards to help safeguard the quality and availability of medicines in Europe and beyond. Official reference standards are essential for the application of the quality control tests described in Ph.\u00a0Eur. texts. Quality and […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/etalons-de-reference\/\" \/>\n<meta property=\"og:site_name\" content=\"EDQM\" \/>\n<meta property=\"article:modified_time\" content=\"2025-07-24T13:07:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/04\/Funded-EU-and-COE-Implemented-COE-quadri-en.png\" \/>\n\t<meta property=\"og:image:width\" content=\"870\" \/>\n\t<meta property=\"og:image:height\" content=\"165\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data1\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/annualreport-2025.guerillainteractive.co.uk\\\/reference-standards\\\/\",\"url\":\"https:\\\/\\\/annualreport-2025.guerillainteractive.co.uk\\\/reference-standards\\\/\",\"name\":\"Reference standards | Quality & use of medicines - 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Official reference standards are essential for the application of the quality control tests described in Ph.\u00a0Eur. texts. 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