{"id":16869,"date":"2026-07-24T13:33:45","date_gmt":"2026-07-24T11:33:45","guid":{"rendered":"https:\/\/q-finity.de\/glossar\/eu-gmp-annex-22-begriff\/"},"modified":"2026-07-26T18:10:20","modified_gmt":"2026-07-26T16:10:20","slug":"eu-gmp-annex-22","status":"publish","type":"encyclopedia","link":"https:\/\/q-finity.de\/en\/glossar\/eu-gmp-annex-22\/","title":{"rendered":"EU GMP Annex 22"},"content":{"rendered":"<p>EU GMP Annex 22 (&ldquo;Artificial Intelligence&rdquo;) is the planned AI annex to the EU GMP guideline (EudraLex Volume 4) &ndash; the first standalone set of rules for AI models in the manufacture of medicinal products and active substances, designed as a supplement to Annex 11. The draft (consultation July to October 2025) covers, in critical applications, only static machine-learning models with deterministic output; it does not apply to generative AI and LLMs, and they should not be used in critical GMP applications. The order of evidence remains two-tiered: the surrounding computerized system is validated under Annex 11 &ndash; the evidence for the embedded model (intended use, acceptance criteria, independent test data, explainability, confidence, operation) is added by Annex 22. Whether this technology boundary survives into the final text is the most commented-on point of the consultation.<\/p>\n<p><em>See also: <a href=\"https:\/\/q-finity.de\/en\/glossar\/eu-gmp-annex-11\/\" target=\"_self\" title='EU GMP Annex 11 (\"Computerised Systems\") is the European GMP annex for computerized systems: introduced in 1992, current in its 2011 version, part of EudraLex Vol. 4. Its principle divides the world of evidence in two: the application is validated, the IT infrastructure is qualified. Annex 11 requires a risk-based approach across the entire lifecycle&hellip;' class=\"encyclopedia\">EU GMP Annex 11<\/a>, AI model, AI system, <a href=\"https:\/\/q-finity.de\/en\/glossar\/intended-use\/\" target=\"_self\" title=\"Intended Use is the purpose a system is meant to serve. That purpose comes from the business process, not from the technical system - which only has a function (fit for purpose). Intended Use defines what the overall system is validated against, and must not be confused with the system's function (the teleological trap).\" class=\"encyclopedia\">Intended Use<\/a>.<\/em><\/p>\n<p><a class=\"qf-glossref\" href=\"https:\/\/q-finity.de\/en\/eu-gmp-annex-22\/\"><span class=\"qf-glossref-body\"><span class=\"qf-glossref-kicker\">Further reading<\/span><span class=\"qf-glossref-text\">Annex 22: draft, roadmap, and readiness<\/span><\/span><span class=\"qf-glossref-arrow\">&rarr;<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>EU GMP Annex 22 (\u201cArtificial Intelligence\u201d) is the planned AI annex to the EU GMP guideline: it adds the evidence for embedded AI models to Annex 11 &#8211; in the draft limited, for critical applications, to static models with deterministic output.<\/p>\n","protected":false},"author":3,"featured_media":0,"template":"","encyclopedia-tag":[],"class_list":["post-16869","encyclopedia","type-encyclopedia","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU GMP Annex 22 &#187; 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