{"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\/en\/certification-of-suitability\/","title":{"rendered":"Certification of suitability to the Ph. Eur. monographs | Quality &#038; use of medicines"},"content":{"rendered":"\t\t<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 of suitability to the Ph. Eur. monographs<\/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>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 active substances, and Certificates of suitability (CEPs) granted to manufacturers provide assurance to both industry and national authorities that their products are adequately controlled by the Ph. Eur. quality standards. CEPs are recognised by all EU states, as well as by Australia, Canada, Morocco, New Zealand, Singapore, South Africa and the World Health Organization, among others.<\/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\">Significant steps in 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\">RTEMIS inspections:<\/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\">On-site inspections:<\/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\">Desktop assessments:<\/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\">New and revised CEPs granted<\/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>In 2023, the EDQM received 381 new CEP applications (\u201310% over 2022) and around 2\u00a0400 CEP revision requests (+9%). Some 442 new certificates (\u20134%) and 1\u00a0416 revised certificates (\u20138%) were issued, and processing times for new dossiers and revisions improved throughout the year. As of 31 December 2023, there were more than 6\u00a0310 valid CEPs covering chemical purity, transmissible spongiform encephalopathy (TSE) and herbal drug preparations.<\/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\">CEPs suspended and\/or withdrawn<\/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>In 2023, 19 CEPs were suspended and\/or withdrawn, mainly after the respective CEP holders were unable to meet the requirements of the procedure for the maintenance of their dossiers, to address the presence of impurities, or due to good manufacturing practice (GMP) non-compliance. One CEP was suspended at the request of the holder. On the other hand, one CEP was restored after the company concerned took appropriate action in response to the suspension of their CEP.<\/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 with Ph. Eur. groups of experts: requests for revision of monographs<\/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>In 2023, 41 requests for revision of Ph.\u00a0Eur. monographs were submitted to the relevant Ph.\u00a0Eur. groups of experts for consideration, mainly proposing the addition of specified impurities to the monograph\u2019s transparency list, together with a suitable test method.<\/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\">The EDQM inspection programme<\/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>The EDQM runs a GMP inspection programme for active substance manufacturers, conducting on-site and remote inspections and using regulatory reliance principles (\u201cdesktop assessments\u201d). A total of 26 on-site inspections were performed in 2023. These were carried out exclusively in India until August 2023, when inspections in China resumed. The EDQM continued the Real-Time Remote Inspections (RTEMIS) programme for the remote supervision of GMP compliance of manufacturing sites. Two such inspections were carried out. The results obtained were satisfactory, both from a technical point of view and in terms of expected outcomes. Finally, the EDQM performed desktop assessments for 35 manufacturing sites by exchanging data with inspectorates from international partners.<\/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\">International co-operation<\/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>Throughout 2023, the Certification Department continued to work closely with national competent authorities in Europe and beyond. This continued co-operation is crucial to ensuring consistency in the approaches applied for the assessment of quality information on active substances, as well as for GMP implementation. The Certification Department worked towards increasing global acceptance of CEPs by welcoming a delegation from the South Korean Ministry of Food and Drug Safety (MFDS).<\/p><p>In May 2023, the Certification Department took over the International API Inspection programme secretariat.<\/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 with applicants, partners and stakeholders<\/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\">From the \u201cCEP of the future\u201d to the implementation of the 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\t\t\t\t<p>The CEP 2.0 (the new name of the \u201cCEP of the future\u201d) was officially launched in September 2023. This \u201cnew look\u201d CEP and associated changes to the procedure were put in place to better meet the needs of stakeholders. The CEP 2.0 offers both enhanced user-friendliness and greater transparency of the information conveyed, without increasing the regulatory burden related to the revision of CEPs. For a while, CEPs in both \u201cnew look\u201d and \u201chybrid look\u201d formats will be issued. This is intended to ease the burden this change represents for all parties involved. \u201cOld look\u201d CEPs (granted before 1 September 2023) remain valid until they are revised.<\/p><p>Throughout the year, the EDQM communicated regularly via its website or in webinars on the changes this project introduces. Additional information has been introduced in the Certification database. More information is now also shared with authorities via the Authorities database.<\/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-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<style>.elementor-element-8a6ec1b{display:none !important}<\/style>\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\">Update of CEP guidelines<\/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>In 2023, the EDQM Certification Department published a number of new or updated guidelines.<\/p><p>CEP application forms were updated to collect unique identification numbers related to the organisations and their localisation and with a revised Holder\u2019s Commitment annex reflecting the CEP holder\u2019s responsibilities towards their customers.<\/p><p>As part of the implementation of the CEP 2.0, the EDQM published <a href=\"https:\/\/www.edqm.eu\/documents\/52006\/156629\/01+New+requirements+for+the+content+of+the+CEP+dossier+for+chemical+purity+and+for+herbal++drugs_herbal+drug+preparations+according+to+the+CEP+2.0+%2810%29.pdf\/39c5bc68-c08b-4f74-a158-049e89891e91?t=1699539918293\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">guidance documents<\/span><\/a> on revised requirements for the CEP dossier and on electronic signatures. The latest updates are available on the <a href=\"https:\/\/www.edqm.eu\/en\/what-is-the-cep-2.0\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">EDQM\u2019s CEP 2.0 information web page<\/span><\/a>, with links to the <span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.edqm.eu\/en\/certification-policy-documents-guidelines\" target=\"_blank\" rel=\"noopener\">Certification Policy Documents &amp; Guidelines web page<\/a><\/span>.<\/p><p>CEP stakeholders were invited, via a public consultation process, to comment on documents\/guidelines issued by the EDQM within the framework of the procedure.<\/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\/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\">View previous content<\/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\/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\">View next content<\/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>\n\t\t","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>\n","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\/en\/certification-of-suitability\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\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. 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