{"id":8790,"date":"2023-06-16T10:01:26","date_gmt":"2023-06-16T08:01:26","guid":{"rendered":"https:\/\/www.sciencepharma.pl\/?post_type=news-events&#038;p=8790"},"modified":"2023-08-04T13:57:25","modified_gmt":"2023-08-04T11:57:25","slug":"cep-2-0-as-new-certification-form-issued-by-edqm-for-demonstrating-substance-used-in-the-preparation-of-medicinal-products-compliance-with-the-european-pharmacopoeia","status":"publish","type":"news-events","link":"https:\/\/www.sciencepharma.com\/pl\/news-events\/cep-2-0-as-new-certification-form-issued-by-edqm-for-demonstrating-substance-used-in-the-preparation-of-medicinal-products-compliance-with-the-european-pharmacopoeia\/","title":{"rendered":"CEP 2.0 as new certification form issued by EDQM for demonstrating substance used in the preparation of medicinal products compliance with the European Pharmacopoeia"},"content":{"rendered":"\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"727\" src=\"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/06\/obraz-16.png\" alt=\"\" class=\"wp-image-7102\" srcset=\"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/06\/obraz-16.png 1024w, https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/06\/obraz-16-300x213.png 300w, https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/06\/obraz-16-768x545.png 768w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>The CEP, as you know, is a \u201cCertificate of suitability to the monographs of the European Pharmacopoeia\u201c. As we can read on the EDQM (European Directorate for the Quality of Medicines and HealthCare) website it is not mandatory, but the preferred option for demonstrating that a substance used in the preparation of medicinal products complies with the European Pharmacopoeia specifications according to the&nbsp;<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-summary-requirements-active-substances-quality-part-dossier-revision-1_en.pdf\">Note for Guidance on summary requirements for active substances in the quality part of the dossier (CPMP \/QWP\/297\/97 Rev 1 corr; EMEA\/CVMP\/1069\/02)<\/a>.<\/p>\n\n\n\n<p><strong>The above-mentioned project is currently being implemented. Why?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>To meet the most recent needs of CEP holders\/API manufacturers, drug product manufacturers, regulatory agencies<\/li>\n\n\n\n<li>To make the registration activities easier<\/li>\n\n\n\n<li>To increase the acceptance of CEPs by EDQM<\/li>\n<\/ul>\n\n\n\n<p><strong>What are the objectives?<\/strong><\/p>\n\n\n\n<p>Mainly:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>To make it easier to use the CEP \u2013 the electronic document with a digital signature, downloadable as a pdf or printed by CEP holders to share with their customers for inclusion in MAA (Marketing Authorisation Application), no paper copy, a new numbering system<\/li>\n\n\n\n<li>To specify the requirements for CEP dossier content and structure so that it contains only the correctly presented required quality data to be reflected on the certificate<\/li>\n\n\n\n<li>To improve information sharing between CEP holders &amp; MAH (Marketing Authorization Holder) \u2013 no declaration of access box in the CEP document anymore, provision the customers by holders with the letter of access according to the template available on the EDQM website<\/li>\n\n\n\n<li>To reduce revisions of CEPs &#8211; CEPs are no longer revised for changes not impacting their content, no renewed CEPs issued<\/li>\n\n\n\n<li>To improve on-line databases &#8211; EMA SPOR\/OMS Organisation (Org) and Location (Loc) ID of a holder, access to short history of finalised procedures, extension of access to some regulatory authorities beyond Ph. Eur.<\/li>\n<\/ul>\n\n\n\n<p>The changes are being implemented successively starting in 2023.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u201cOld look\u201d, \u201chybrid look\u201d and \u201cnew look\u201d CEPs will coexist for some time.<\/li>\n\n\n\n<li>The \u201cnew look\u201d CEP is issued for any new CEP granted and after the renewal procedure.<\/li>\n\n\n\n<li>\u201cHybrid look\u201d is used after revision of existing dossiers when there is no impact on the information reported on the CEP.<\/li>\n\n\n\n<li>The \u201cold look\u201d CEPs granted before the implementation of CEP 2.0 will still be valid until they get revised.<\/li>\n<\/ul>\n\n\n\n<p>Are you interested in the CEP2.0? Please, use the dedicated website: <a href=\"https:\/\/www.edqm.eu\/en\/what-is-the-cep-2.0\">https:\/\/www.edqm.eu\/en\/what-is-the-cep-2.<\/a><\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>If you are the API manufacturer, drug product manufacturer or MAH planning the activities related to the product registration or the CEP application, please contact SciencePharma, we will be happy to help you.<\/p>\n<\/blockquote>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The CEP, as you know, is a \u201cCertificate of suitability to the monographs of the European Pharmacopoeia\u201c. As we can read on the EDQM (European Directorate for the Quality of Medicines and HealthCare) website it is not mandatory, but the preferred option for demonstrating that a substance used in the preparation of medicinal products complies [&hellip;]<\/p>\n","protected":false},"featured_media":9379,"template":"","meta":{"inline_featured_image":false},"typ":[80],"class_list":["post-8790","news-events","type-news-events","status-publish","has-post-thumbnail","hentry","typ-news-pl"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CEP 2.0 as new certification form issued by EDQM for demonstrating substance used in the preparation of medicinal products compliance with the European Pharmacopoeia - SciencePharma<\/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:\/\/www.sciencepharma.com\/pl\/news-events\/cep-2-0-as-new-certification-form-issued-by-edqm-for-demonstrating-substance-used-in-the-preparation-of-medicinal-products-compliance-with-the-european-pharmacopoeia\/\" \/>\n<meta property=\"og:locale\" content=\"pl_PL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CEP 2.0 as new certification form issued by EDQM for demonstrating substance used in the preparation of medicinal products compliance with the European Pharmacopoeia - SciencePharma\" \/>\n<meta property=\"og:description\" content=\"The CEP, as you know, is a \u201cCertificate of suitability to the monographs of the European Pharmacopoeia\u201c. 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