{"id":7227,"date":"2025-09-02T09:40:55","date_gmt":"2025-09-02T07:40:55","guid":{"rendered":"https:\/\/www.thescon.de\/?p=7227"},"modified":"2025-09-02T09:42:41","modified_gmt":"2025-09-02T07:42:41","slug":"gmp-updates-new-drafts-for-chapter-4-annex-11-22","status":"publish","type":"post","link":"https:\/\/www.thescon.de\/en\/gmp-updates-new-drafts-for-chapter-4-annex-11-22\/","title":{"rendered":"GMP Updates: New Drafts for Chapter 4, Annex 11 &#038; 22"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7227\" class=\"elementor elementor-7227\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6a120f1a elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"6a120f1a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4e37094c\" data-id=\"4e37094c\" 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-3d04afb2 elementor-widget elementor-widget-text-editor\" data-id=\"3d04afb2\" 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<h3>GMP Regulations in Transition: What You Need to Know<\/h3><p><strong>New Requirements for Documentation, Validation, and AI Systems<\/strong><\/p><p>With the new drafts of Chapter 4, Annex 11, and the newly published Annex 22 on Artificial Intelligence, the GMP world is facing a significant update. The documents are currently open for public consultation &#8211; until October 7, 2025, companies, professional associations, and individuals have the opportunity to submit feedback.<\/p><p>The drafts bring far-reaching changes:<\/p><ul><li>Chapter 4 expands requirements for documentation, data lifecycle, and governance<\/li><li><strong>Annex 11<\/strong> clarifies validation, audit trails, cloud usage, and cybersecurity<\/li><li><strong>Annex 22<\/strong> defines regulatory requirements for AI systems in the GxP environment<\/li><\/ul><p>\u00a0<\/p><p>In our webinar, Dr. Annabel Dischinger will explain which changes are particularly relevant, how they could affect existing processes, and how you can already position yourself strategically.<\/p><p>\u00a0<\/p><p><strong>Event details:<\/strong><\/p><ul><li>Date: Thursday, September 11, 2025<\/li><li>Time: 11:00 a.m.<\/li><li>Duration: approx. 30 minutes<\/li><\/ul><p>\u00a0<\/p><p>Participation is free of charge. Secure your spot now via the contact form and receive your access details.<\/p><p>\u00a0<\/p><p>We look forward to seeing you \u2013 and to exploring together how you can proactively adapt to the new regulatory requirements in the GMP environment.<\/p><p>\u00a0<\/p><p><em>Note: Participation is reserved for Thescon customers and prospects. Service providers and consultants are excluded.<\/em><\/p><p>\u00a0<\/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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Webinar on the Latest Regulatory Drafts<\/p>\n<p>Join Dr. Annabel Dischinger in our webinar to learn about the changes in the drafts of Chapter 4, Annex 11, and Annex 22 \u2013 and how to prepare for them.<\/p>\n","protected":false},"author":11,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11,16,13],"tags":[],"class_list":["post-7227","post","type-post","status-publish","format-standard","hentry","category-events","category-news","category-web-seminars"],"_links":{"self":[{"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/posts\/7227","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/comments?post=7227"}],"version-history":[{"count":5,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/posts\/7227\/revisions"}],"predecessor-version":[{"id":7237,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/posts\/7227\/revisions\/7237"}],"wp:attachment":[{"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/media?parent=7227"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/categories?post=7227"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/tags?post=7227"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}