Introducing the AI Community of Practice (CoP) Regulatory Subcommittee: Enabling AI in Pharma through Regulatory Knowledge

Purpose and Mission

The Regulatory Subcommittee exists to help the industry understand and build regulatory expectations around AI in pharma and to support regulators as expectations take shape globally. The subcommittee aims to:

• Provide a forum for members to share challenges and solutions in applying AI under good manufacturing practices (GMP) and in dossier registration settings
• Disseminate knowledge and best practices through blog posts, Pharmaceutical Engineering^® articles, webinars, training, and conference sessions
• Facilitate dialogue and harmonization with health authorities by tracking and contextualizing evolving positions, terminology, and definitions and by serving as a key hub for commenting on regulator-issued guidance in the field

Scope

The subcommittee has intentionally kept its scope broad: any topic of interest to regulators, regulatory authorities, and regulatory professionals about AI in the biopharmaceutical industry is in scope. Near term, focus areas include:

• Regulatory Guidance Knowledge: Monitoring and summarizing emerging AI guidance across regions (e.g., US Food and Drug Administration, European Medicines Agency, international agencies), with attention to oversight triggers, reporting expectations, alignment/divergence across regions, and terminology that affects GMP practice and filings
• Commenting Activities: Supporting ISPE’s coordination of comments on relevant AI guidance (e.g., Annex 22) to surface cross industry perspectives and align feedback across ISPE communities
• AI Use Cases: Gathering and presenting use cases that are dossier relevant or require regulatory oversight, and outlining the documentation and controls that build regulator confidence

Looking Ahead

Through these activities, the subcommittee aims to build a robust knowledge base and help harmonize regulatory expectations for AI. Here’s what’s coming next:

• iSpeak Blog Series: The subcommittee is developing a series that summarizes existing AI guidance and addresses practical questions it raises. The first post will be an overview of what guidance is currently with future posts looking more closely at individual guidance, comparing guidance, and building a knowledgebase on how to navigate the regulatory aspects of AI in the biopharmaceutical industry. Check back on iSpeak for the upcoming post.
• Pharmaceutical Engineering Articles: Two subcommittee members have published in the January/February 2026 Issue of Pharmaceutical Engineering.
  • Kabir Ahluwalia (Amgen Inc.) has co-authored an article, “A Cohesive Vision for a Single Global Chemistry, Manufacturing, and Controls (CMC) Dossier.” This article provides an overview and proposal for next steps to enable a single digital dossier in CMC submissions, including technological solutions, regulatory mechanisms, and key barriers to achieving this vision.
  • Victor Bechmann (Kuatro Group) has co-authored an article, “Seven Control Layers for Large Language Models (LLMs) in GMP Decision-Making.” This article introduces a layered risk-control strategy for integrating LLMs into automated decision-making processes.
• Upcoming Webinar: “From Prompt to Proof: AI for DEA Compliance and GxP Manufacturing Investigations” takes place Tuesday, 17 March from 1600 to 1700 EST.
  • In this webinar, John Clapham (CEO, PSC Biotech Corporation) covers how BioTechnique® used generative AI to author Drug Enforcement Administration-compliant standard operating procedures and forms, integrated them into PSC Software’s validated ACE enterprise platform, and supported audit readiness with AI driven analytics, along with Annex 22/GMP considerations for sterile fill finish.
  • This webinar also focuses on AI’s role in quality investigations. Brian Chviruk (Quality Systems Operations Leader, Takeda) will demonstrate how AI-enabled tools strengthen investigation quality and productivity in a regulated GxP environment. Register today.

Join the Conversation

The ISPE AI CoP Regulatory Subcommittee invites ISPE members to share knowledge, contribute use cases, comment on evolving guidance, and co-create resources that make compliant AI implementation easier for everyone. To participate, or simply learn, the Regulatory Subcommittee meets on the third Thursday of every month. Participation in the AI CoP’s Applications, Models and Data, Preparedness and Workforce, and Regulatory Subcommittees is open to all active ISPE members.

ISPE members interested in learning more, please email the Communities@ISPE.org.