{"id":377,"date":"2024-04-24T16:31:27","date_gmt":"2024-04-24T16:31:27","guid":{"rendered":"http:\/\/annualreport.edqm.eu\/?page_id=377"},"modified":"2024-06-10T20:40:37","modified_gmt":"2024-06-10T20:40:37","slug":"certification-of-suitability","status":"publish","type":"page","link":"https:\/\/annualreport2023.edqm.eu\/fr\/certification-of-suitability\/","title":{"rendered":"Certification de conformit\u00e9 aux monographies de la Ph. Eur."},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"377\" class=\"elementor elementor-377\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2cd9617d elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle elementor-invisible\" data-id=\"2cd9617d\" 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-4e0d46bd\" data-id=\"4e0d46bd\" 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-c41e3ef elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"c41e3ef\" 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-fb2fe31\" data-id=\"fb2fe31\" 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\">Certification de conformit\u00e9 aux monographies de la Ph. Eur.<\/h1>\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-4d741aa5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4d741aa5\" 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-5f7050ff\" data-id=\"5f7050ff\" 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-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>La proc\u00e9dure de Certification de conformit\u00e9 a \u00e9t\u00e9 \u00e9tablie pour \u00e9valuer et valider la capacit\u00e9 des normes de la Ph. Eur. \u00e0 contr\u00f4ler la qualit\u00e9 des substances utilis\u00e9es dans la fabrication des m\u00e9dicaments. Elle comprend un programme d\u2019inspection des sites de fabrication de substances actives, et les certificats de conformit\u00e9 aux monographies de la Ph. Eur. (CEP) accord\u00e9s aux fabricants garantissent \u00e0 l\u2019industrie et aux Autorit\u00e9s nationales que les produits concern\u00e9s sont correctement contr\u00f4l\u00e9s par les normes qualit\u00e9 de la Ph. Eur. Les CEP sont reconnus par tous les \u00c9tats de l\u2019UE, mais aussi par l\u2019Afrique du Sud, l\u2019Australie, le Canada, le Maroc, la Nouvelle-Z\u00e9lande, Singapour et par l\u2019Organisation mondiale de la Sant\u00e9, entre autres.<\/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-5fe60695\" data-id=\"5fe60695\" 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-47ee32d6 elementor-widget elementor-widget-image\" data-id=\"47ee32d6\" 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=\"1000\" height=\"667\" src=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/03-CEP-Inspection.jpg\" class=\"attachment-full size-full wp-image-846\" alt=\"\" srcset=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/03-CEP-Inspection.jpg 1000w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/03-CEP-Inspection-300x200.jpg 300w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/03-CEP-Inspection-768x512.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/>\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\">\u00c9tapes importantes concernant la certification<\/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-e8607d4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e8607d4\" 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-25 elementor-inner-column elementor-element elementor-element-60c246a\" data-id=\"60c246a\" 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-894eacc elementor-widget elementor-widget-image\" data-id=\"894eacc\" 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=\"948\" height=\"609\" src=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-01-Certification-Inspection.png\" class=\"attachment-full size-full wp-image-757\" alt=\"\" srcset=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-01-Certification-Inspection.png 948w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-01-Certification-Inspection-300x193.png 300w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-01-Certification-Inspection-768x493.png 768w\" sizes=\"(max-width: 948px) 100vw, 948px\" \/>\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-25 elementor-inner-column elementor-element elementor-element-79311f0\" data-id=\"79311f0\" 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-4f6ab4a no-margin elementor-widget elementor-widget-heading\" data-id=\"4f6ab4a\" 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\">Inspections RTEMIS<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c359629 elementor-widget elementor-widget-counter\" data-id=\"c359629\" data-element_type=\"widget\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"500\" data-to-value=\"2\" data-from-value=\"0\" data-delimiter=\",\">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\"><\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\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-25 elementor-inner-column elementor-element elementor-element-22099ca\" data-id=\"22099ca\" 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-fa6f132 no-margin elementor-widget elementor-widget-heading\" data-id=\"fa6f132\" 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\">Sur site<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b0a0e2d elementor-widget elementor-widget-counter\" data-id=\"b0a0e2d\" data-element_type=\"widget\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"1500\" data-to-value=\"26\" data-from-value=\"0\" data-delimiter=\",\">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\"><\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\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-25 elementor-inner-column elementor-element elementor-element-becbe6b\" data-id=\"becbe6b\" 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-0ca59ee no-margin elementor-widget elementor-widget-heading\" data-id=\"0ca59ee\" 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\">\u00c9valuations documentaires<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d3650cc elementor-widget elementor-widget-counter\" data-id=\"d3650cc\" data-element_type=\"widget\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"35\" data-from-value=\"0\" data-delimiter=\",\">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\"><\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\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-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\">Nouveaux CEP et CEP r\u00e9vis\u00e9s d\u00e9livr\u00e9s<\/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>En 2023, l\u2019EDQM a re\u00e7u 381 nouvelles demandes de CEP (\u2013 10 % par rapport \u00e0 2022) et environ 2 400 demandes de r\u00e9vision de CEP (+ 9 %). Quelque 442 nouveaux CEP (\u2013 4 %) et 1 416 CEP r\u00e9vis\u00e9s (\u2013 8 %) ont \u00e9t\u00e9 d\u00e9livr\u00e9s, et une am\u00e9lioration des d\u00e9lais de traitement des nouveaux dossiers et des r\u00e9visions a \u00e9t\u00e9 observ\u00e9e tout au long de l\u2019ann\u00e9e. Au 31 d\u00e9cembre 2023, le nombre de CEP en cours de validit\u00e9, qu\u2019ils couvrent la puret\u00e9 chimique, le risque d\u2019enc\u00e9phalopathie spongiforme transmissible (EST) ou les pr\u00e9parations \u00e0 base de drogues v\u00e9g\u00e9tales, s\u2019\u00e9levait \u00e0 plus de 6 310.<\/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\">CEP suspendus et\/ou retir\u00e9s<\/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>En 2023, 19 CEP ont \u00e9t\u00e9 suspendus et\/ou retir\u00e9s, principalement en raison de l\u2019incapacit\u00e9 de leurs titulaires \u00e0 satisfaire aux exigences de la proc\u00e9dure de tenue \u00e0 jour de leurs dossiers, \u00e0 agir sur la pr\u00e9sence d\u2019impuret\u00e9s ou \u00e0 se conformer aux bonnes pratiques de fabrication (BPF). Un CEP a \u00e9t\u00e9 suspendu \u00e0 la demande de son titulaire. Parall\u00e8lement, un autre a \u00e9t\u00e9 restaur\u00e9 apr\u00e8s que l\u2019entreprise concern\u00e9e a pris des mesures appropri\u00e9es en r\u00e9action \u00e0 la suspension de son certificat.<\/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-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\">Communication avec les groupes d\u2019expert\u00b7es de la Ph.\u2009Eur. : demandes de r\u00e9vision de monographies<\/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>En 2023, 41 demandes de r\u00e9vision de monographies de la Ph. Eur. ont \u00e9t\u00e9 soumises pour examen aux groupes d\u2019expert\u00b7es concern\u00e9s, principalement pour proposer l\u2019ajout d\u2019impuret\u00e9s sp\u00e9cifi\u00e9es \u00e0 la liste de transparence des monographies en question, ainsi qu\u2019une m\u00e9thode d\u2019essai appropri\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<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\">Programme d\u2019inspection de l\u2019EDQM<\/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>L\u2019EDQM pilote un programme d\u2019inspection visant \u00e0 v\u00e9rifier la conformit\u00e9 aux BPF des fabricants de substances actives, dans le cadre duquel elle m\u00e8ne des inspections sur site ou \u00e0 distance sur la base du principe de confiance r\u00e9glementaire (\u00ab \u00e9valuations documentaires \u00bb). En 2023, 26 inspections sur site ont \u00e9t\u00e9 effectu\u00e9es, en Inde uniquement jusqu\u2019au mois d\u2019ao\u00fbt, puis en Chine \u00e9galement. L\u2019EDQM a poursuivi le programme d\u2019inspections \u00e0 distance en temps r\u00e9el (RTEMIS) concernant le contr\u00f4le \u00e0 distance de la conformit\u00e9 aux BPF des sites de fabrication. Deux inspections de ce type ont eu lieu dans l\u2019ann\u00e9e. Les r\u00e9sultats obtenus se sont av\u00e9r\u00e9s satisfaisants, du point de vue technique comme de celui des r\u00e9sultats escompt\u00e9s. L\u2019EDQM a, en outre, r\u00e9alis\u00e9 des \u00e9valuations documentaires pour 35 sites de fabrication, en \u00e9changeant des donn\u00e9es avec les corps d\u2019inspection de partenaires internationaux.<\/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\">Coop\u00e9ration internationale<\/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>Tout au long de l\u2019ann\u00e9e 2023, le Service de la Certification des substances de l\u2019EDQM a continu\u00e9 de travailler en \u00e9troite collaboration avec les Autorit\u00e9s nationales comp\u00e9tentes d\u2019Europe et d\u2019ailleurs. Cette coop\u00e9ration permanente est primordiale pour assurer la coh\u00e9rence des approches adopt\u00e9es dans le cadre de l\u2019\u00e9valuation des informations qualit\u00e9 relatives aux substances actives, ainsi que de la mise en application des BPF. Le Service de la Certification des substances a \u0153uvr\u00e9 \u00e0 une plus large acceptation mondiale des CEP en accueillant une d\u00e9l\u00e9gation du minist\u00e8re sud-cor\u00e9en de la S\u00e9curit\u00e9 alimentaire et pharmaceutique (MFDS).<\/p><p>En mai 2023, il a pris la rel\u00e8ve du secr\u00e9tariat du programme international d\u2019inspection des sites de fabrication de substances actives.<\/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\">Communication avec les demandeurs, les partenaires et les parties int\u00e9ress\u00e9es<\/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-9eabbd5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9eabbd5\" 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-df6e569\" data-id=\"df6e569\" 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-47f4a40 elementor-widget elementor-widget-heading\" data-id=\"47f4a40\" 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\">Apr\u00e8s le CEP du futur, l\u2019impl\u00e9mentation du CEP 2.0<\/h4>\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-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-3946e34{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-8a6ec1b elementor-widget elementor-widget-text-editor\" data-id=\"8a6ec1b\" 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>Le CEP 2.0 (nouvelle appellation du \u00ab CEP du futur \u00bb) a \u00e9t\u00e9 lanc\u00e9 officiellement en septembre 2023. Ce CEP \u00ab nouvelle formule \u00bb et les changements apport\u00e9s \u00e0 la proc\u00e9dure en cons\u00e9quence ont \u00e9t\u00e9 mis en place afin de mieux r\u00e9pondre aux besoins des parties int\u00e9ress\u00e9es. Le CEP 2.0 offre une plus grande convivialit\u00e9 et une meilleure transparence des informations transmises, sans pour autant alourdir la charge r\u00e9glementaire li\u00e9e aux r\u00e9visions de CEP. Pendant un certain temps, les CEP seront d\u00e9livr\u00e9s selon la \u00ab nouvelle formule \u00bb et la \u00ab formule hybride \u00bb, afin d\u2019all\u00e9ger le poids que cela repr\u00e9sente pour toutes les parties impliqu\u00e9es. Les CEP \u00ab ancienne formule \u00bb (accord\u00e9s avant le 1<sup>er<\/sup> septembre 2023) resteront valides jusqu\u2019\u00e0 leur r\u00e9vision.<\/p><p>Tout au long de l\u2019ann\u00e9e, l\u2019EDQM a r\u00e9guli\u00e8rement communiqu\u00e9 \u00e0 propos des changements r\u00e9sultant de ce projet, sur son site web ou par le biais de webinaires. Des informations compl\u00e9mentaires ont \u00e9t\u00e9 introduites dans la base de donn\u00e9es Certification. D\u2019autres informations sont d\u00e9sormais \u00e9galement partag\u00e9es avec les autorit\u00e9s via la base de donn\u00e9es Autorit\u00e9s.<\/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-1d5bd0c\" data-id=\"1d5bd0c\" 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-f508cda elementor-widget elementor-widget-heading\" data-id=\"f508cda\" 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\">Mise \u00e0 jour des <em>guidelines<\/em> relatifs aux CEP<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d347e87 elementor-widget elementor-widget-text-editor\" data-id=\"d347e87\" 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>En 2023, le Service de la Certification des substances a publi\u00e9 plusieurs guidelines, nouveaux ou r\u00e9vis\u00e9s.<\/p><p>Les formulaires de demande de CEP ont \u00e9t\u00e9 mis \u00e0 jour : les num\u00e9ros d\u2019identification propres \u00e0 chaque organisation et \u00e0 chaque site doivent d\u00e9sormais \u00eatre renseign\u00e9s, et l\u2019annexe \u00ab Holder\u2019s Commitment \u00bb (engagement des titulaires) a \u00e9t\u00e9 r\u00e9vis\u00e9e de sorte \u00e0 refl\u00e9ter les responsabilit\u00e9s des titulaires de CEP envers leur client\u00e8le.<\/p><p class=\"translation-block\">Dans le cadre de l\u2019impl\u00e9mentation du CEP 2.0, l\u2019EDQM a publi\u00e9 des documents d\u2019orientation portant sur les exigences r\u00e9vis\u00e9es relatives aux dossiers de CEP et sur les signatures \u00e9lectroniques. Les derni\u00e8res mises \u00e0 jour documents sont disponibles sur la <a href=\"https:\/\/www.edqm.eu\/fr\/what-is-the-cep-2.0\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline\">la page d\u2019information consacr\u00e9e au CEP 2.0<\/span><\/a>, du site web de l\u2019EDQM, avec des liens vers la page web des <span style=\"text-decoration: underline\"><a href=\"https:\/\/www.edqm.eu\/fr\/certification-policy-documents-guidelines\" target=\"_blank\" rel=\"noopener\">Documents et Lignes Directrices Certification<\/a><\/span>.<\/p><p>Les parties int\u00e9ress\u00e9es ont \u00e9t\u00e9 invit\u00e9es, lors d\u2019une phase de consultation publique, \u00e0 commenter les documents\/guidelines publi\u00e9s par l\u2019EDQM dans le cadre de la proc\u00e9dure.<\/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-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\/reference-standards\/\">\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\/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-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 Certification of suitability to the Ph. Eur. monographs The Certification of suitability procedure was set up to evaluate and validate the capacity of Ph. Eur. standards to control the quality of substances used in the manufacture of medicinal products. It includes a programme for the inspection of manufacturing sites of [&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-377","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>Certification of suitability to the Ph. Eur. monographs | 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\/certification-of-suitability\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Certification of suitability to the Ph. Eur. monographs | Quality &amp; use of medicines - EDQM\" \/>\n<meta property=\"og:description\" content=\"Quality &#038; use of medicines Certification of suitability to the Ph. Eur. monographs The Certification of suitability procedure was set up to evaluate and validate the capacity of Ph. Eur. standards to control the quality of substances used in the manufacture of medicinal products. It includes a programme for the inspection of manufacturing sites of [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/annualreport2023.edqm.eu\/fr\/certification-of-suitability\/\" \/>\n<meta property=\"og:site_name\" content=\"EDQM\" \/>\n<meta property=\"article:modified_time\" content=\"2024-06-10T20:40:37+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/03-CEP-Inspection.jpg\" \/>\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=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/\",\"url\":\"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/\",\"name\":\"Certification of suitability to the Ph. Eur. monographs | Quality & use of medicines - EDQM\",\"isPartOf\":{\"@id\":\"https:\/\/annualreport2023.edqm.eu\/en\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/03-CEP-Inspection.jpg\",\"datePublished\":\"2024-04-24T16:31:27+00:00\",\"dateModified\":\"2024-06-10T20:40:37+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/#primaryimage\",\"url\":\"http:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/03-CEP-Inspection.jpg\",\"contentUrl\":\"http:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/03-CEP-Inspection.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/annualreport2023.edqm.eu\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Certification of suitability to the Ph. Eur. monographs | Quality &#038; use of medicines\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/annualreport2023.edqm.eu\/en\/#website\",\"url\":\"https:\/\/annualreport2023.edqm.eu\/en\/\",\"name\":\"EDQM\",\"description\":\"2023 Annual Report\",\"publisher\":{\"@id\":\"https:\/\/annualreport2023.edqm.eu\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/annualreport2023.edqm.eu\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/annualreport2023.edqm.eu\/en\/#organization\",\"name\":\"EDQM\",\"url\":\"https:\/\/annualreport2023.edqm.eu\/en\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\/\/annualreport2023.edqm.eu\/en\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/04\/cropped-EDQM-Favicon.jpg\",\"contentUrl\":\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/04\/cropped-EDQM-Favicon.jpg\",\"width\":512,\"height\":512,\"caption\":\"EDQM\"},\"image\":{\"@id\":\"https:\/\/annualreport2023.edqm.eu\/en\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Certification of suitability to the Ph. Eur. monographs | Quality & use of medicines - EDQM","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/annualreport2023.edqm.eu\/fr\/certification-of-suitability\/","og_locale":"fr_FR","og_type":"article","og_title":"Certification of suitability to the Ph. Eur. monographs | Quality & use of medicines - EDQM","og_description":"Quality &#038; use of medicines Certification of suitability to the Ph. Eur. monographs The Certification of suitability procedure was set up to evaluate and validate the capacity of Ph. Eur. standards to control the quality of substances used in the manufacture of medicinal products. It includes a programme for the inspection of manufacturing sites of [&hellip;]","og_url":"https:\/\/annualreport2023.edqm.eu\/fr\/certification-of-suitability\/","og_site_name":"EDQM","article_modified_time":"2024-06-10T20:40:37+00:00","og_image":[{"url":"http:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/03-CEP-Inspection.jpg","type":"","width":"","height":""}],"twitter_card":"summary_large_image","twitter_misc":{"Dur\u00e9e de lecture estim\u00e9e":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/","url":"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/","name":"Certification of suitability to the Ph. Eur. monographs | Quality & use of medicines - EDQM","isPartOf":{"@id":"https:\/\/annualreport2023.edqm.eu\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/#primaryimage"},"image":{"@id":"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/#primaryimage"},"thumbnailUrl":"http:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/03-CEP-Inspection.jpg","datePublished":"2024-04-24T16:31:27+00:00","dateModified":"2024-06-10T20:40:37+00:00","breadcrumb":{"@id":"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/#breadcrumb"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/#primaryimage","url":"http:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/03-CEP-Inspection.jpg","contentUrl":"http:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/03-CEP-Inspection.jpg"},{"@type":"BreadcrumbList","@id":"https:\/\/annualreport2023.edqm.eu\/certification-of-suitability\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/annualreport2023.edqm.eu\/en\/"},{"@type":"ListItem","position":2,"name":"Certification of suitability to the Ph. Eur. monographs | Quality &#038; use of medicines"}]},{"@type":"WebSite","@id":"https:\/\/annualreport2023.edqm.eu\/en\/#website","url":"https:\/\/annualreport2023.edqm.eu\/en\/","name":"EDQM","description":"2023 Annual Report","publisher":{"@id":"https:\/\/annualreport2023.edqm.eu\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/annualreport2023.edqm.eu\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/annualreport2023.edqm.eu\/en\/#organization","name":"EDQM","url":"https:\/\/annualreport2023.edqm.eu\/en\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/annualreport2023.edqm.eu\/en\/#\/schema\/logo\/image\/","url":"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/04\/cropped-EDQM-Favicon.jpg","contentUrl":"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/04\/cropped-EDQM-Favicon.jpg","width":512,"height":512,"caption":"EDQM"},"image":{"@id":"https:\/\/annualreport2023.edqm.eu\/en\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/annualreport2023.edqm.eu\/fr\/wp-json\/wp\/v2\/pages\/377","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/annualreport2023.edqm.eu\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/annualreport2023.edqm.eu\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/annualreport2023.edqm.eu\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/annualreport2023.edqm.eu\/fr\/wp-json\/wp\/v2\/comments?post=377"}],"version-history":[{"count":0,"href":"https:\/\/annualreport2023.edqm.eu\/fr\/wp-json\/wp\/v2\/pages\/377\/revisions"}],"wp:attachment":[{"href":"https:\/\/annualreport2023.edqm.eu\/fr\/wp-json\/wp\/v2\/media?parent=377"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}