{"id":10275,"date":"2026-06-25T13:28:08","date_gmt":"2026-06-25T11:28:08","guid":{"rendered":"https:\/\/www.qualipharmagroup.com\/?p=10275"},"modified":"2026-06-25T13:28:59","modified_gmt":"2026-06-25T11:28:59","slug":"ema-workshop-artificial-intelligence-in-gmp-future-annex-22","status":"publish","type":"post","link":"https:\/\/www.qualipharmagroup.com\/en\/blog\/ema-workshop-artificial-intelligence-in-gmp-future-annex-22\/","title":{"rendered":"EMA Workshop on Artificial Intelligence in GMP: a key point for the future Annex 22"},"content":{"rendered":"<p><span data-contrast=\"auto\">The European Medicines Agency (EMA) will hold a multistakeholder workshop on 30 June focused on the incorporation of artificial intelligence into GMP environments, with the objective of collecting technical and regulatory input for the development of the future EU GMP Annex 22, currently under review.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Although the event has not yet taken place, its announcement already represents an important signal: the EMA recognizes the need to review and further develop how the use of artificial intelligence should be regulated within GxP processes and systems.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3 style=\"font-weight: 400;\"><strong>A draft that has generated debate<\/strong><\/h3>\n<p style=\"font-weight: 400;\">The initial draft of Annex 22 introduced a particularly conservative position regarding the use of artificial intelligence in critical GMP processes, significantly limiting the use of dynamic, adaptive, and probabilistic models.<\/p>\n<p style=\"font-weight: 400;\">This approach has generated debate within the sector, and the organization of this workshop suggests that the EMA is open to reconsidering part of this approach based on technical evidence and practical experience provided by experts from industry, academia, and other stakeholders.<\/p>\n<p style=\"font-weight: 400;\">According to the agenda published by the EMA, the workshop will address several aspects that will likely be decisive for the final version of Annex 22.<\/p>\n<h3 style=\"font-weight: 400;\"><strong>Principles for acceptable AI in GMP environments<\/strong><\/h3>\n<p style=\"font-weight: 400;\">One of the key points will be the definition of the requirements that an AI must meet to be considered suitable in a GMP environment, including aspects such as robustness, traceability, explainability, and reproducibility.<\/p>\n<p style=\"font-weight: 400;\">This approach aims to transfer classical validation and quality assurance principles to systems based on algorithmic models.<\/p>\n<h3 style=\"font-weight: 400;\"><strong>Risk, technical reliability, and compliance boundaries<\/strong><\/h3>\n<p style=\"font-weight: 400;\">The workshop will analyze aspects related to risk management, compliance boundaries, and the technical reliability of AI systems, as well as the response to incidents.<\/p>\n<p style=\"font-weight: 400;\">In this context, typical risks associated with AI systems (for example, non-deterministic behavior or model degradation) may be considered within the framework of system reliability assessment and control.<\/p>\n<p style=\"font-weight: 400;\">Likewise, the EMA has indicated interest in exploring control and mitigation measures, introducing the concept of <em>guardrails<\/em>, understood as mechanisms intended to limit, monitor, and contain model behavior within a risk-based approach.<\/p>\n<h3 style=\"font-weight: 400;\"><strong>Data governance<\/strong><\/h3>\n<p style=\"font-weight: 400;\">Data management will be another pillar of the discussion, with particular focus on: dataset quality, traceability, versioning, segregation of GMP and non-<a href=\"https:\/\/www.qualipharmagroup.com\/en\/blog\/chapter-iv-annex-11-and-annex-22-key-principles-of-data-governance-and-ai-in-gmp\/\">GMP data<\/a>, and data integrity under ALCOA+ principles.<\/p>\n<h3 style=\"font-weight: 400;\"><strong>New validation models<\/strong><\/h3>\n<p style=\"font-weight: 400;\">The EMA will also open the discussion on how to validate AI beyond the classical IQ\/OQ\/PQ models, which could imply the incorporation of concepts such as challenge testing, boundary testing, continuous monitoring, etc.<\/p>\n<h3 style=\"font-weight: 400;\"><strong>Human oversight<\/strong><\/h3>\n<p style=\"font-weight: 400;\">The principle of <em>Human-in-the-loop<\/em> will foreseeably be consolidated as an essential requirement for any AI application in critical GMP processes.<\/p>\n<h3 style=\"font-weight: 400;\"><strong>Cybersecurity and outsourced activities<\/strong><\/h3>\n<p style=\"font-weight: 400;\">The workshop will address cybersecurity and outsourced activities in AI systems applied to GMP as a critical risk area and will evaluate the risks when the infrastructure is outside the direct control of the manufacturer and how to preserve control.<\/p>\n<h3 style=\"font-weight: 400;\"><strong>What it could mean for Annex 22<\/strong><\/h3>\n<p style=\"font-weight: 400;\">Although it is still too early to anticipate conclusions, this workshop could have a significant influence on the final drafting of Annex 22.<\/p>\n<p style=\"font-weight: 400;\">Among the possible changes that could arise after the discussion process, the following may be highlighted:<br \/>\n\u2022 An evolution from prohibition towards a risk-based approach;<br \/>\n\u2022 The formal incorporation of <em>guardrails<\/em> as a regulatory requirement;<br \/>\n\u2022 The adoption of a specific lifecycle for AI models;<br \/>\n\u2022 And a reinterpretation of the concept of validated state in non-deterministic systems.<\/p>\n<h3 style=\"font-weight: 400;\"><strong>An event that may shape the regulatory direction<\/strong><\/h3>\n<p><span data-contrast=\"auto\">Beyond its technical content, this workshop may become a turning point for the pharmaceutical sector and for all regulated GxP environments.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The way in which the <a href=\"https:\/\/www.ema.europa.eu\/es\/events\/good-manufacturing-practice-multistakeholder-workshop-expert-contributions-artificial-intelligence-guidance-development-annex-22\">EMA<\/a> decides to integrate artificial intelligence into the GMP framework will have a direct impact on the implementation of AI in regulated environments, as well as on validation strategies, supplier qualification, and operational oversight in the coming years.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Therefore, this event will not only be relevant for what is discussed, but also for what it may anticipate about the future European regulatory framework for artificial intelligence in regulated environments; and the event will be available to follow live\u2026<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The European Medicines Agency (EMA) will hold a multistakeholder workshop on 30 June focused on the incorporation of artificial intelligence into GMP environments, with the objective of collecting technical and regulatory input for the development of the future EU GMP Annex 22, currently under review.\u00a0 Although the event has not yet taken place, its announcement [&hellip;]<\/p>\n","protected":false},"author":40,"featured_media":10279,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[118],"tags":[],"class_list":["post-10275","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-csv"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EMA Workshop on Artificial Intelligence in GMP: a key 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