{"id":8506,"date":"2025-07-23T13:48:39","date_gmt":"2025-07-23T05:48:39","guid":{"rendered":"https:\/\/regask.com\/?p=8506"},"modified":"2025-07-23T13:50:16","modified_gmt":"2025-07-23T05:50:16","slug":"aktualisierung-der-dokumentation-der-eu-gmp-leitlinien-2025-fur-computergestutzte-ki-systeme","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/","title":{"rendered":"Europ\u00e4ische Kommission startet \u00f6ffentliche Konsultation zur Aktualisierung\u2026"},"content":{"rendered":"<p>An <strong>7. Juli 2025<\/strong>, Die <a href=\"https:\/\/commission.europa.eu\/about\/departments-and-executive-agencies\/health-and-food-safety_en\"><strong>Generaldirektion Gesundheit und Lebensmittelsicherheit der Europ\u00e4ischen Kommission<\/strong><\/a> er\u00f6ffnete ein <strong>\u00f6ffentliche Konsultation<\/strong> \u00fcber vorgeschlagene \u00c4nderungen an <strong>EudraLex Band 4 \u2013 Leitlinien zur Guten Herstellungspraxis (GMP)<\/strong>Die Aktualisierungen gelten f\u00fcr:<\/p>\n<ul>\n<li><strong>Kapitel 4: Dokumentation<\/strong><\/li>\n<li><strong>Anhang 11: Computergest\u00fctzte Systeme<\/strong><\/li>\n<li><strong>Anhang 22: K\u00fcnstliche Intelligenz<\/strong> <em>(neu eingef\u00fchrt)<\/em><\/li>\n<\/ul>\n<p>Diese vorgeschlagenen \u00c4nderungen zielen darauf ab, <strong>Modernisierung der GMP-Praktiken<\/strong> durch die St\u00e4rkung <strong>Datenintegrit\u00e4t<\/strong>, Integration <strong>KI-Governance<\/strong>und die Verbesserung der Aufsicht \u00fcber <strong>computergest\u00fctzte Systeme<\/strong> Und <strong>Dokumentation<\/strong> In <strong>pharmazeutische Herstellung<\/strong>.<\/p>\n<p><strong>Wichtige Highlights:<\/strong><\/p>\n<ul>\n<li>Der <strong>aktualisiertes Kapitel 4<\/strong> betont <strong>risikobasierte Dokumentationspraktiken<\/strong>, zusammen mit einem verbesserten Management von <strong>elektronische Aufzeichnungen<\/strong> Und <strong>Unterschriften<\/strong>und gleichzeitig die <strong>Lesbarkeit und Integrit\u00e4t<\/strong> der Dokumentation in allen Formaten.<\/li>\n<li>Der <strong>\u00fcberarbeiteter Anhang 11<\/strong> verst\u00e4rkt die Anwendung von <strong>Qualit\u00e4tsrisikomanagement (QRM)<\/strong> w\u00e4hrend des gesamten Lebenszyklus von <strong>computergest\u00fctzte Systeme<\/strong>, Einf\u00fchrung strengerer Kontrollen f\u00fcr <strong>Audit-Studien<\/strong>, <strong>Systemsicherheit<\/strong>, Und <strong>Lieferanten\u00fcberwachung<\/strong>.<\/li>\n<li>Der <strong>neu eingef\u00fchrter Anhang 22<\/strong> schafft einen klaren Regelungsrahmen f\u00fcr die Nutzung von <strong>K\u00fcnstliche Intelligenz im GMP-Umfeld<\/strong>, die Anforderungen in Bezug auf <strong>Modellvalidierung<\/strong>, <strong>Qualit\u00e4t der Trainingsdaten<\/strong>, <strong>Leistungsmetriken<\/strong>, Und <strong>kontinuierliche menschliche Aufsicht<\/strong>.<\/li>\n<\/ul>\n<h4><strong>R\u00fcckmeldungsfrist: 7. Oktober 2025<\/strong><\/h4>\n\t<div id=\"gap-1565890061\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1565890061 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>Warum es wichtig ist:<\/strong><br \/>Von diesen \u00dcberarbeitungen wird erwartet, dass sie:<\/p>\n<ul>\n<li>Erweitern <strong>regulatorische Klarheit<\/strong><\/li>\n<li>Ausrichten mit <strong>aufkommende digitale Technologien<\/strong><\/li>\n<li>F\u00f6rdern <strong>Betriebseffizienz<\/strong><\/li>\n<li>Einf\u00fchren <strong>minimale neue Compliance-Belastungen<\/strong><\/li>\n<\/ul>\n<p><strong>Der Input der Stakeholder wird eine entscheidende Rolle bei der Gestaltung praktischer und am technologischen Fortschritt ausgerichteter Leitlinien spielen.<\/strong> Diese Updates sind besonders relevant f\u00fcr Fachleute in <strong>Qualit\u00e4t, Regulatory Affairs, IT-Compliance und KI-Einsatz in GMP-<\/strong>regulierten Umgebungen.<\/p>\n<p><strong>N\u00e4chste Schritte<\/strong><br \/>Die Stakeholder sollten die \u00dcberarbeitungsentw\u00fcrfe zu Kapitel 4, Anhang 11 und Anhang 22 pr\u00fcfen, die internen Auswirkungen bewerten und funktions\u00fcbergreifendes Feedback koordinieren. Kommentare m\u00fcssen \u00fcber das <a href=\"https:\/\/health.ec.europa.eu\/consultations\/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en\">Portal der Europ\u00e4ischen Kommission von <strong>7. Oktober 2025<\/strong>.<\/a><\/p>\n<p><strong>Wie RegASK hilft<\/strong><br \/>RegASK ist eine KI-gesteuerte Plattform, die fortlaufend regulatorische Aktualisierungen, einschlie\u00dflich GMP- und KI-Richtlinien, \u00fcberwacht, um Life-Science-Teams dabei zu unterst\u00fctzen, konform und vorbereitet zu bleiben.<br \/><a href=\"https:\/\/regask.com\/de\/\"><strong>Mehr erfahren<\/strong><\/a><strong> oder <\/strong><a href=\"https:\/\/regask.com\/de\/demo-buchen\/\"><strong>Demo buchen<\/strong><\/a><\/p>\n<div class=\"is-divider divider clearfix\" style=\"margin-top:1em;margin-bottom:1em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n\t<div id=\"gap-566304520\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-566304520 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><strong>FAQs<\/strong><\/h4>\n\t<div id=\"gap-153616433\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-153616433 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<ol>\n<li><strong> Was ist Anhang 22 des aktualisierten EU-GMP-Leitfadens?<\/strong><br \/>\nAnhang 22 ist ein neu vorgeschlagener Abschnitt unter EudraLex Band 4. Er legt die regulatorischen Anforderungen f\u00fcr den Einsatz k\u00fcnstlicher Intelligenz in der Arzneimittelherstellung fest, einschlie\u00dflich Modellvalidierung, Trainingsdatenstandards und menschlicher Aufsicht.<\/li>\n<li><strong> Welche \u00c4nderungen werden an computergest\u00fctzten Systemen gem\u00e4\u00df Anhang 11 vorgenommen?<\/strong><br \/>\nDer aktualisierte Anhang 11 f\u00fchrt strengere Qualit\u00e4tsrisikomanagement-Praktiken f\u00fcr computergest\u00fctzte Systeme ein. Der Schwerpunkt liegt auf Auditpr\u00fcfungen, elektronischen Signaturen, Systemsicherheit und Lieferanten\u00fcberwachung.<\/li>\n<li><strong> Welche Dokumentationsanforderungen enth\u00e4lt das \u00fcberarbeitete Kapitel 4 der EU-GMP?<\/strong><br \/>\nDas \u00fcberarbeitete Kapitel 4 legt den Schwerpunkt auf Datenintegrit\u00e4t, risikobasierte Governance und den ordnungsgem\u00e4\u00dfen Umgang mit Dokumentationen aller Formate. Es versch\u00e4rft au\u00dferdem die Anforderungen an die Verwaltung elektronischer Aufzeichnungen und Signaturen.<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>Am 7. Juli 2025 er\u00f6ffnete die Generaldirektion Gesundheit und Lebensmittelsicherheit der Europ\u00e4ischen Kommission eine \u00f6ffentliche Konsultation zu vorgeschlagenen \u00c4nderungen an EudraLex Band 4 \u2013 Leitlinien zur Guten Herstellungspraxis (GMP). Die Aktualisierungen betreffen: Kapitel 4: Dokumentation, Anhang 11: Computergest\u00fctzte Systeme, Anhang 22: K\u00fcnstliche Intelligenz (neu eingef\u00fchrt). Die vorgeschlagenen \u00c4nderungen zielen auf die Modernisierung der GMP-Praktiken ab\u2026<\/p>","protected":false},"author":32,"featured_media":8508,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[529,33],"tags":[],"class_list":["post-8506","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>European Commission Launches GMP Consultation | RegASK<\/title>\n<meta name=\"description\" content=\"The EU launches a public consultation on GMP updates covering AI, computerized systems, and documentation. 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