Introducing the ISPE Artificial Intelligence (AI) Community of Practice (CoP) Applications, Models, and Data Subcommittee: Pioneering Responsible AI in GxP Environments

ISPE’s AI Community of Practice (CoP) was formed in 2024 to give ISPE members a space to explore and discuss the use of AI in the pharmaceutical industry. Since then, discussions have focused on areas such as the regulatory aspects of AI, guidance on applications of AI throughout the pharmaceutical life cycle, organizational preparedness for implementation of AI, benchmarking, workforce education and skills development, and organizational impacts. The new ISPE AI CoP Applications, Models, and Data Subcommittee will be dedicated to advancing the responsible and effective use of AI and machine learning (ML) technologies in GxP environments. Our mission is to gather expertise, provide industry guidance, establish best practices, and foster knowledge-sharing to ensure AI/ML implementations are robust, compliant, and impactful in GxP settings, focusing on applications, models, data, infrastructure, and security considerations.

Our Purpose and Mission

The ISPE AI CoP Applications, Models, and Data Subcommittee aims to guide the pharmaceutical industry in leveraging AI/ML technologies while maintaining data integrity, model reliability, and security. By concentrating on practical applications, model development, and data governance, the CoP subcommittee seeks to empower organizations to harness AI/ML capabilities responsibly. Its mission is to create a collaborative platform where industry professionals can share insights, develop standards, and drive innovation in GxP environments, complementing the work of the AI CoP AI Preparedness and Workforce Development and AI Regulatory Subcommittees.

Key Areas of Focus

The AI CoP Applications, Models, and Data Subcommittee will concentrate on three core domains to address the unique challenges and opportunities of AI/ML in GxP settings:

• Application Domains: The CoP subcommittee will identify and document GxP use cases where AI/ML technologies deliver significant value
• Model Development and Validation: The subcommittee plans to establish frameworks for developing, testing, and validating AI/ML models, emphasising ethics, bias mitigation, and qualification processes to ensure reliability and compliance
• Data Governance: The subcommittee aims to define standards for data acquisition, preparation, and management, ensuring data quality, security, and infrastructure readiness to support robust AI/ML implementations

Planned Deliverables

To achieve these goals, the AI CoP Applications, Models, and Data Subcommittee is committed to producing actionable resources for the industry, including:

• Industry surveys to assess current AI/ML implementation practices
• A use case catalogue showcasing pharmaceutical applications of AI/ML
• A data quality framework tailored for AI/ML, building on existing data integrity work
• An implementation playbook to guide organizations in assessing AI/ML capabilities
• Case studies highlighting successful AI/ML implementations in GxP environments
• A benchmarking framework for evaluating generative AI model performance specific to GxP requirements

Collaboration and Engagement

The AI CoP Applications, Models, and Data Subcommittee will work closely with other ISPE groups, including the AI Preparedness and Workforce Subcommittee on terminology and training, the AI Regulatory Subcommittee on compliance considerations, and initiatives like GAMP® and Pharma 4.0™ on overlapping guidance and standards. These collaborations ensure the subcommittee’s focus remains on applications, models, and data, while aligning with broader AI/ML efforts. The subcommittee also welcomes partnerships with external organizations to broaden its impact.

The subcommittee hosts monthly meetings, held on the first Thursday of each month, which provide a forum for discussion and decision-making. ISPE members passionate about AI/ML applications, models, and data are encouraged to join these meetings and contribute to shaping the future of AI in the pharmaceutical industry.

Conclusion

The AI CoP Applications, Models, and Data Subcommittee is poised to drive responsible AI/ML adoption in GxP environments. The subcommittee invites ISPE members to engage, share expertise, and help develop guidance that will drive innovation while upholding the highest standards of quality and compliance. Together, the subcommittee sees an opportunity for ISPE to unlock the transformative potential of AI/ML in pharmaceuticals.

Participation on the ISPE AI CoP Applications, Models, Data Subcommittee, as well as participation on the two other AI CoP Subcommittees: Preparedness and Workforce and Regulatory, are open to all active ISPE members.

Learn More about Communities of Practice

For more information, please email Communities@ISPE.org.