{"id":377,"date":"2024-04-24T16:31:27","date_gmt":"2024-04-24T16:31:27","guid":{"rendered":"http:\/\/annualreport-2025.guerillainteractive.co.uk\/?page_id=377"},"modified":"2025-07-24T13:07:19","modified_gmt":"2025-07-24T13:07:19","slug":"certification-de-conformite","status":"publish","type":"page","link":"https:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/certification-de-conformite\/","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-c28b7c4 elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle elementor-invisible\" data-id=\"c28b7c4\" data-element_type=\"section\" data-e-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;}\" data-no-translation=\"\">\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-f6d46ea\" data-id=\"f6d46ea\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4fe38cf elementor-widget elementor-widget-heading\" data-id=\"4fe38cf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1998b40 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"1998b40\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\" data-no-translation=\"\">\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-4f3dc92\" data-id=\"4f3dc92\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-410b362 elementor-widget elementor-widget-heading\" data-id=\"410b362\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<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-2a83f44 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2a83f44\" data-element_type=\"section\" data-e-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-100 elementor-inner-column elementor-element elementor-element-e0b78f1\" data-id=\"e0b78f1\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ddbd842 elementor-widget elementor-widget-text-editor\" data-id=\"ddbd842\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>La proc\u00e9dure de Certification de conformit\u00e9 aux monographies de la Ph.\u00a0Eur. (aussi appel\u00e9e \u00ab\u00a0proc\u00e9dure de Certification\u00a0\u00bb) a \u00e9t\u00e9 \u00e9tablie pour \u00e9valuer et valider la conformit\u00e9 des substances utilis\u00e9es dans la fabrication des m\u00e9dicaments aux normes qualit\u00e9 de la Ph.\u00a0Eur. Elle repose notamment sur un programme d\u2019inspection des sites de fabrication de substances actives. Les certificats de conformit\u00e9 aux monographies de la Ph.\u00a0Eur. (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.\u00a0Eur. Ils sont reconnus par tous les \u00c9tats membres de l\u2019UE, ainsi que par de nombreux partenaires internationaux, dont l\u2019Afrique du Sud, l\u2019Australie, le Br\u00e9sil, le Canada, le Maroc, la Nouvelle-Z\u00e9lande, Singapour et l\u2019OMS.<\/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-fbe6b01 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"fbe6b01\" data-element_type=\"section\" data-e-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;}\" data-no-translation=\"\">\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-e94add6\" data-id=\"e94add6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d2f7a18 elementor-widget elementor-widget-heading\" data-id=\"d2f7a18\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Activit\u00e9s de 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-0783447 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0783447\" data-element_type=\"section\" data-e-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-2b8897f\" data-id=\"2b8897f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-26b1481 elementor-widget elementor-widget-image\" data-id=\"26b1481\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"370\" height=\"401\" src=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2025\/05\/Sig-Steps_1.png\" class=\"attachment-full size-full wp-image-1812\" alt=\"\" srcset=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2025\/05\/Sig-Steps_1.png 370w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2025\/05\/Sig-Steps_1-277x300.png 277w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2025\/05\/Sig-Steps_1-11x12.png 11w\" sizes=\"(max-width: 370px) 100vw, 370px\" \/>\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-1b823a2\" data-id=\"1b823a2\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-416becf no-margin elementor-widget elementor-widget-heading\" data-id=\"416becf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Nouvelles demandes de CEP<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e641097 elementor-widget elementor-widget-spacer\" data-id=\"e641097\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c8b6eed elementor-widget elementor-widget-counter\" data-id=\"c8b6eed\" data-element_type=\"widget\" data-e-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=\"469\" 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<div class=\"elementor-element elementor-element-5e58bce no-margin elementor-widget elementor-widget-heading\" data-id=\"5e58bce\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">(+23%)<\/h4>\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-56680d8\" data-id=\"56680d8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-bc20b76 no-margin elementor-widget elementor-widget-heading\" data-id=\"bc20b76\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Demandes de r\u00e9vision de CEP<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-48b4774 elementor-widget elementor-widget-counter\" data-id=\"48b4774\" data-element_type=\"widget\" data-e-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=\"2360\" 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<div class=\"elementor-element elementor-element-5e31935 no-margin elementor-widget elementor-widget-heading\" data-id=\"5e31935\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">(-2%)<\/h4>\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-fb855dd\" data-id=\"fb855dd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-eef9769 no-margin elementor-widget elementor-widget-heading\" data-id=\"eef9769\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Demandes de r\u00e9vision de monographies de la Ph. Eur.<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8f55a53 elementor-widget elementor-widget-counter\" data-id=\"8f55a53\" data-element_type=\"widget\" data-e-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=\"43\" 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<div class=\"elementor-element elementor-element-74d06c2 no-margin elementor-widget elementor-widget-heading\" data-id=\"74d06c2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">(+2%)<\/h4>\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-b17c829 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b17c829\" data-element_type=\"section\" data-e-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-f8a5347\" data-id=\"f8a5347\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-850a759 elementor-widget elementor-widget-heading\" data-id=\"850a759\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Nouveaux CEP et CEP r\u00e9vis\u00e9s<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ca772b6 elementor-widget elementor-widget-text-editor\" data-id=\"ca772b6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>En\u00a02024, l\u2019EDQM a consid\u00e9rablement \u00e9largi ses activit\u00e9s en rapport avec la proc\u00e9dure de Certification. En effet, elle a re\u00e7u, en tout, 469\u00a0nouvelles demandes de CEP (+23\u00a0% par rapport \u00e0\u00a02023) et 2\u00a0360\u00a0demandes de r\u00e9vision (-2\u00a0%). Au final, 581\u00a0nouveaux CEP (+31\u00a0%) et 1\u00a0732\u00a0CEP r\u00e9vis\u00e9s (+18\u00a0%) ont \u00e9t\u00e9 d\u00e9livr\u00e9s. Par ailleurs, un raccourcissement 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\u00a0d\u00e9cembre\u00a02024, 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\u00a0800.<\/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-ed70b14\" data-id=\"ed70b14\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b5c32c5 elementor-widget elementor-widget-heading\" data-id=\"b5c32c5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">CEP suspendus 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-029ea77 elementor-widget elementor-widget-text-editor\" data-id=\"029ea77\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>En\u00a02024, 10 CEP ont \u00e9t\u00e9 suspendus ou retir\u00e9s, principalement en raison du non-respect des bonnes pratiques de fabrication (BPF), ce qui souligne l\u2019importance des inspections de l\u2019EDQM. En outre, 15\u00a0CEP ont \u00e9t\u00e9 suspendus \u00e0 la demande de leurs titulaires. Parall\u00e8lement, 17\u00a0CEP ont \u00e9t\u00e9 restaur\u00e9s apr\u00e8s que les entreprises concern\u00e9es ont pris des mesures appropri\u00e9es en r\u00e9action \u00e0 la suspension de leur 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-1012a74 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1012a74\" data-element_type=\"section\" data-e-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-100 elementor-inner-column elementor-element elementor-element-d8af599\" data-id=\"d8af599\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dd11ba2 elementor-widget elementor-widget-heading\" data-id=\"dd11ba2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<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-d11bf3a elementor-widget elementor-widget-text-editor\" data-id=\"d11bf3a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>En\u00a02024, 43\u00a0demandes de r\u00e9vision de monographies de la Ph.\u00a0Eur. 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. Cet aspect de la proc\u00e9dure de Certification contribue \u00e0 garantir que les monographies de la Ph.\u00a0Eur. continuent \u00e0 r\u00e9pondre aux besoins \u00e9volutifs de leurs utilisateurs et utilisatrices.<\/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-b2cc2f7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b2cc2f7\" data-element_type=\"section\" data-e-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-100 elementor-inner-column elementor-element elementor-element-75ed9e2\" data-id=\"75ed9e2\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3e1245f elementor-widget elementor-widget-heading\" data-id=\"3e1245f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<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\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-c619191 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c619191\" data-element_type=\"section\" data-e-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-bd24c48\" data-id=\"bd24c48\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-97ca33d elementor-widget elementor-widget-image\" data-id=\"97ca33d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"948\" height=\"609\" src=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Icon-01-Certification-Inspection.png\" class=\"attachment-full size-full wp-image-757\" alt=\"\" srcset=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Icon-01-Certification-Inspection.png 948w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Icon-01-Certification-Inspection-300x193.png 300w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/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-e686539\" data-id=\"e686539\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c1ec076 elementor-widget elementor-widget-counter\" data-id=\"c1ec076\" data-element_type=\"widget\" data-e-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=\"30\" 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<div class=\"elementor-element elementor-element-653e368 no-margin elementor-widget elementor-widget-heading\" data-id=\"653e368\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">inspections sur site<\/h4>\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-9759ae6\" data-id=\"9759ae6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5897555 elementor-widget elementor-widget-counter\" data-id=\"5897555\" data-element_type=\"widget\" data-e-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=\"1\" 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<div class=\"elementor-element elementor-element-218a7fd no-margin elementor-widget elementor-widget-heading\" data-id=\"218a7fd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">inspection RTEMIS<\/h4>\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-ac85cda\" data-id=\"ac85cda\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0bb2830 elementor-widget elementor-widget-counter\" data-id=\"0bb2830\" data-element_type=\"widget\" data-e-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=\"79\" 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<div class=\"elementor-element elementor-element-d40c6ee no-margin elementor-widget elementor-widget-heading\" data-id=\"d40c6ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">\u00e9valuations documentaires<\/h4>\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-1f1f8b8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1f1f8b8\" data-element_type=\"section\" data-e-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-100 elementor-inner-column elementor-element elementor-element-0d5bb18\" data-id=\"0d5bb18\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7db576d elementor-widget elementor-widget-text-editor\" data-id=\"7db576d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>L\u2019EDQM poursuit son 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 (RTEMIS, \u00ab\u00a0<em>Real-Time Remote Inspection System<\/em>\u00a0\u00bb), ainsi que des v\u00e9rifications sur la base du principe de confiance r\u00e9glementaire (\u00ab\u00a0\u00e9valuations documentaires\u00a0\u00bb). En\u00a02024, un total de 31\u00a0inspections a \u00e9t\u00e9 effectu\u00e9 (30 sur site et une \u00e0 distance), en Asie principalement. En outre, l\u2019EDQM a renforc\u00e9 son programme d\u2019inspection\u00a0BPF sur la base du principe de confiance en doublant le nombre d\u2019\u00e9valuations documentaires des sites de fabrication\u00a0: elle a ainsi r\u00e9alis\u00e9 79\u00a0\u00e9valuations de ce type 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-cb43200 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"cb43200\" data-element_type=\"section\" data-e-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;}\" data-no-translation=\"\">\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-59ca91e\" data-id=\"59ca91e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b7b1be4 elementor-widget elementor-widget-heading\" data-id=\"b7b1be4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">La proc\u00e9dure de Certification : 30 ans d\u2019excellence scientifique<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c56e5e5 elementor-widget elementor-widget-text-editor\" data-id=\"c56e5e5\" data-element_type=\"widget\" data-e-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-c56e5e5{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-6008822 elementor-widget elementor-widget-text-editor\" data-id=\"6008822\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Visionnez la \u00a0<a href=\"https:\/\/player.vimeo.com\/video\/1095858341\" target=\"_blank\" rel=\"noopener\">session consacr\u00e9e au 30<sup>e<\/sup>\u00a0anniversaire de la proc\u00e9dure de Certification<\/a> (en VO), qui s\u2019est tenue lors de la conf\u00e9rence du 60<sup>e<\/sup>\u00a0anniversaire de l\u2019EDQM, pour suivre un d\u00e9bat anim\u00e9 et informatif sur la fa\u00e7on dont la proc\u00e9dure de Certification t\u00e9moigne du d\u00e9vouement de l\u2019EDQM envers la qualit\u00e9, la collaboration et la protection de la sant\u00e9 publique. Pour les versions avec interpr\u00e9tation fran\u00e7aise, voir le site internet de l\u2019EDQM\u00a0: \u00ab\u00a0<a href=\"https:\/\/www.edqm.eu\/fr\/11-12-june-2024-celebrating-60-years-of-excellence-in-public-health-protection\" target=\"_blank\" rel=\"noopener\">Aujourd&#8217;hui comme demain, ensemble pour la sant\u00e9 publique<\/a>\u00a0\u00bb.<\/p><p>\u00a0<\/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-4231fe4 elementor-widget elementor-widget-video\" data-id=\"4231fe4\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;video_type&quot;:&quot;vimeo&quot;}\" data-widget_type=\"video.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-wrapper elementor-open-inline\">\n\t\t\t<iframe class=\"elementor-video-iframe\" allowfullscreen allow=\"clipboard-write\" title=\"Lecteur vid\u00e9o vimeo\" src=\"https:\/\/player.vimeo.com\/video\/1095858341?color&amp;autopause=0&amp;loop=0&amp;muted=0&amp;title=1&amp;portrait=1&amp;byline=1#t=\"><\/iframe>\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-top-section elementor-element elementor-element-c3c15cc elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"c3c15cc\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\" data-no-translation=\"\">\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-f4acfc6\" data-id=\"f4acfc6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e485a1a elementor-widget elementor-widget-heading\" data-id=\"e485a1a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<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-1d6f4c1 elementor-widget elementor-widget-text-editor\" data-id=\"1d6f4c1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Tout au long de l\u2019ann\u00e9e\u00a02024, le Service de la Certification des substances de l\u2019EDQM a continu\u00e9 de collaborer \u00e9troitement avec les Autorit\u00e9s nationales comp\u00e9tentes (ANC) 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.<\/p><p>En octobre\u00a02024, l\u2019EDQM a salu\u00e9 la d\u00e9cision de l\u2019autorit\u00e9 br\u00e9silienne (Anvisa) de s\u2019appuyer sur la proc\u00e9dure d\u2019\u00e9valuation des CEP dans son processus de prise de d\u00e9cision concernant la qualit\u00e9 des substances actives.<\/p><p>Conform\u00e9ment \u00e0 l\u2019un de ses objectifs strat\u00e9giques, l\u2019EDQM s\u2019efforce de r\u00e9pondre aux difficult\u00e9s et priorit\u00e9s actuelles et \u00e9mergentes en mati\u00e8re de sant\u00e9 publique, au b\u00e9n\u00e9fice des patients et patientes et des consommateurs et consommatrices. En ce qui concerne la proc\u00e9dure de Certification, cela implique d\u2019\u00e9tudier la possibilit\u00e9 d\u2019accro\u00eetre la reconnaissance de ses r\u00e9sultats d\u2019inspection.<\/p><p>En\u00a02024, le Service de la Certification des substances a continu\u00e9 d\u2019assurer le secr\u00e9tariat du programme international d\u2019inspection des sites de fabrication de substances actives. Ce programme est une initiative de diverses autorit\u00e9s et organisations du monde entier visant \u00e0 accro\u00eetre l\u2019efficacit\u00e9 de leurs activit\u00e9s d\u2019inspection\u00a0BPF respectives en s\u2019appuyant davantage sur le principe de confiance r\u00e9glementaire et en r\u00e9duisant les redondances inutiles.<\/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-7df152b elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"7df152b\" data-element_type=\"section\" data-e-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;}\" data-no-translation=\"\">\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-c9d5631\" data-id=\"c9d5631\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-94ab744 elementor-widget elementor-widget-heading\" data-id=\"94ab744\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<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-0f43baa elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0f43baa\" data-element_type=\"section\" data-e-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-a302810\" data-id=\"a302810\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7c70ab5 elementor-widget elementor-widget-heading\" data-id=\"7c70ab5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Faciliter la compr\u00e9hension et l\u2019utilisation de la proc\u00e9dure de Certification<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b8c910c elementor-widget elementor-widget-text-editor\" data-id=\"b8c910c\" data-element_type=\"widget\" data-e-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>En avril et novembre\u00a02024, le Service de la Certification des substances a organis\u00e9 des webinaires destin\u00e9s aux parties int\u00e9ress\u00e9es afin de partager des informations et de recueillir des retours sur l\u2019exp\u00e9rience utilisateur du CEP\u00a02.0, sur les difficult\u00e9s \u00e9ventuellement rencontr\u00e9es lors de la pr\u00e9paration d\u2019un dossier de CEP, sur l\u2019utilisation des CEP, ainsi que sur l\u2019acc\u00e8s aux <em>guidelines <\/em>de l\u2019EDQM en la mati\u00e8re et sur leur compr\u00e9hension (voir la liste de webinaires sous <a href=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/notre-bilan\/\"><em>Notre bilan<\/em><\/a>).<\/p><p>Tout au long de l\u2019ann\u00e9e, l\u2019EDQM a r\u00e9guli\u00e8rement communiqu\u00e9 sur ces activit\u00e9s sur son site web.<\/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-d1c3702\" data-id=\"d1c3702\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a4e6939 elementor-widget elementor-widget-heading\" data-id=\"a4e6939\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Mise \u00e0 jour des guidelines 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-935467c elementor-widget elementor-widget-text-editor\" data-id=\"935467c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>En\u00a02024, le Service de la Certification des substances a publi\u00e9 plusieurs <em>guidelines<\/em>, nouveaux ou r\u00e9vis\u00e9s. Parmi ceux-ci, des documents cl\u00e9s sur la pr\u00e9paration des dossiers de CEP ont \u00e9t\u00e9 r\u00e9vis\u00e9s afin d\u2019accompagner les demandeurs lors de la soumission de dossiers et dans un souci d\u2019harmonisation avec les exigences r\u00e9glementaires les plus r\u00e9centes. Dans le cadre de la proc\u00e9dure de Certification, les parties int\u00e9ress\u00e9es ont \u00e9t\u00e9 invit\u00e9es, lors d\u2019une phase de consultation publique, \u00e0 commenter les projets de document et de <em>guideline <\/em>publi\u00e9s par l\u2019EDQM. Pour en savoir plus, consultez la <a href=\"https:\/\/www.edqm.eu\/fr\/certification\" target=\"_blank\" rel=\"noopener\">page web de l\u2019EDQM consacr\u00e9e \u00e0 la certification<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\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-621a432 elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"621a432\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;}\" data-no-translation=\"\">\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-77f3cf3 elementor-invisible\" data-id=\"77f3cf3\" data-element_type=\"column\" data-e-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-72cc9ec elementor-widget elementor-widget-button\" data-id=\"72cc9ec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/etalons-de-reference\/\">\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-e0c25bc elementor-invisible\" data-id=\"e0c25bc\" data-element_type=\"column\" data-e-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-2f83197 elementor-align-right elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"2f83197\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/reseau-europeen-des-laboratoires-officiels-de-controle-des-medicaments\/\">\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 &amp; use of medicines Qualit\u00e9 et utilisation des m\u00e9dicaments Certification of suitability to the Ph.&nbsp;Eur. monographs The Certification of suitability procedure was set up to evaluate and validate the conformity of substances used in the manufacture of medicinal products with the quality standards of the Ph.\u00a0Eur. It includes a programme for the inspection of [&hellip;]<\/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-377","page","type-page","status-publish","hentry","entry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Certification of suitability to the Ph. 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