Annex 22

Remote Monitoring and Management ContinuousOS Service Management Managed Threat Response IaaS Qualification AI cEMS Generative AI Continuous Temperature Mapping LIMS Industrial Optimization SaaS Ambient Agents ISO/IEC 42001 CDMS Module Type Package Continuous Intelligent Validation FDA AI Standards AI Agentic Continuous Validation AI in GxP Summit IT Operations Management Risk Management Project Manava Margo Standard Operational Excellence MTP Agentic Framework cCMMS Laboratory Information Management System AI Safety Continuous Validation PLCs cTM FDA Special Programs Chatbots ContinuousSM ContinuousLabs Software Validation Podcast Software Development Life Cycle Alarms Management FDA CSA Chat with Data ContinuousRM ContinuousDM Implementing AI Continuous CMMS Enterprise AI Document Management ContinuousITOM OT Operations Management ContinuousDI cDI Suite Predictive Maintenance ContinuousGPT AI Co-pilots ContinuousALM cIV VAM DAM Preventive Maintenance ALM GxP ContinuousRMM Advanced Manufacturing Continuous Environmental Monitoring System Continuous Robotic Process Automation Temperature Mapping NIST COSAIS SaaS Validation Cloud Validation Life Cycle Governance PaaS Qualification ContinuousTM GxP AI Search ContinuousPM DataOps AI in Coding Predictive Analytics CAM SDLC Webinar Service as a Software (SaaS)Intelligent Maintenance Risk Assessment xTelligent One Artificial Intelligence Email Protection ContinuousPdM cRPA ContinuousMTR ContinuousMP Data Integrity cLCG Incident Operations Management AI Leadership Pharmaceutical Manufacturing Clinical Data Management xLM Process Intelligence Audit Continuous Governance Annex 22 xTelliGent Two

Annex 22Annex 22

Sep 17, 2025

#077: Annex 22: A Landmark in Regulating AI for Pharma Manufacturing

Artificial Intelligence (AI) is transforming industries worldwide. In pharmaceutical manufacturing, the stakes are high. AI models here affect patient safety, product quality, and regulatory compliance. The European Medicines Agency (EMA) introduced Annex 22—the first regulatory guideline for AI in GMP (Good Manufacturing Practice) environments. Published in 2023 and under industry consultation, it is expected to become law by late 2025 or early 2026.

Nagesh Nama, +1

Annex 22Annex 22

Jul 23, 2025

#069: EU's Annex 22 Draft Guideline on Artificial Intelligence

The EU Annex 22: Artificial Intelligence (Draft) represents the first formal regulatory guidance specifically aimed at overseeing AI systems within GMP-regulated environments.

Nagesh Nama, +1