Nov 12, 2025
Articles
On October 6, 2025, the European Union published the draft of Annex 22 to the Good Manufacturing Practices (GMP) — the first regulation that explicitly governs Artificial Intelligence (AI) in pharmaceutical manufacturing.
In this article, we review the key points, their impact on the industry, and how companies can prepare to leverage AI safely and in compliance with regulations.
What Annex 22 Is and Why It Matters
Annex 22 builds on existing GMP guidelines and represents a major milestone: for the first time, the EU explicitly regulates the use of AI across all stages of pharmaceutical manufacturing.
AI enhances efficiency and predictability but also introduces new risks: automated decision-making, algorithmic bias, dependence on complex digital systems, and the need to ensure data integrity.
Annex 22 provides clear criteria to ensure AI systems operate within quality and compliance standards.
Key Requirements Under Annex 22
To comply with Annex 22, companies should pay close attention to several essential elements:
Validation and reliability: Algorithms must demonstrate that they fulfill their intended purpose without posing risks to product quality.
Transparency and traceability: AI must be auditable — it should be possible to explain how decisions are made, avoiding the “black box” effect.
Risk management: Identify potential failures, biases, or deviations and implement preventive measures.
Data integrity: AI-generated results are considered critical records and must comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, etc.).
Continuous monitoring: Systems must be reviewed throughout their lifecycle to ensure consistent performance.
These requirements ensure safety and compliance — while also providing auditors and regulators with confidence, a critical factor in the pharmaceutical industry.
How to Prepare for AI Under Regulation
Implementing AI in line with Annex 22 calls for a comprehensive digital strategy:
Integrate AI into validated electronic and cloud systems.
Train teams in good data practices and AI risk management.
Redesign processes with traceability and compliance in mind from the start.
Continuously document and audit all AI systems.
Companies that adopt AI under these standards will not only meet regulatory expectations but also stand out in innovation, efficiency, and quality, sending a strong message of excellence to clients and partners.
When Will Annex 22 Take Effect?
Annex 22 is currently in draft form, so there is no official enforcement date yet.
After an industry and expert consultation phase, the final version will be published, likely including a transition period of several months for companies to adapt their systems and processes while maintaining compliance.
Annex 22: The Challenge and the Opportunity
Annex 22 marks a turning point for the industry: for the first time, the EU establishes a specific regulatory framework for AI in pharmaceutical manufacturing.
The challenge is significant, adapting to requirements, validating, and continuously monitoring intelligent systems.
The opportunity, even greater, optimizing processes, improving quality, and strengthening competitiveness.
Adopting AI under regulation allows the pharmaceutical industry to innovate safely, responsibly, and in compliance, combining digital transformation with trust.
