The new Guide provides a holistic framework for developing and using AI in GxP regulated areas.
NORTH BETHESDA, Md., July 23, 2025 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) has announced the availability of the "ISPE GAMP® Guide: Artificial Intelligence," a comprehensive guidance document focusing on artificial intelligence (AI) in the pharmaceutical industry.
"To date, no singular source of comprehensive guidance for use of AI has been available for the pharmaceutical industry," said Brandi Stockton, originator and responsible lead for the Guide and Founder and CEO for The Triality Group LLC. "Successful development of this Guide would not have been possible without the collective experience of the more than 20 ISPE members representing various companies and academia and the constructive feedback from industry peer-reviewers." Stockton is also an active member of the new ISPE Artificial Intelligence Community of Practice (CoP) and co-lead for the GAMP Software Automation and Artificial Intelligence Special Interest Group.
The new Guide provides a holistic framework for the effective and efficient use of AI, outlining its possibilities and limitations. This framework intends to help organizations enable innovation, positioning data as a "backbone" of AI-enabled systems while keeping patient safety, product quality, and data integrity at the forefront of decision-making.
"In our experience, we are only seeing a few projects making it past the pilot stage. So, we've asked ourselves, why is this the case? Innovation is often risky, but when many people lack an understanding of basic AI-related terminology and processes, AI implementation can be a real challenge. Thus, we saw a need for this Guide, which can serve as a singular reference point for a diverse set of stakeholders," said Martin Heitmann, co-lead for the Guide, Secretary of the GAMP Global Software Automation and Artificial Intelligence Special Interest Group, and Consultant with The Triality Group, LLC.
The Guide also focuses on how to secure alignment among all stakeholders (e.g., pharmaceutical companies, medical device manufacturers, service providers, software providers, and regulatory authorities). It explores how organizations can establish a common language to support collaboration across diverse stakeholders, follow best practices for AI implementation, incorporate key considerations for knowledge management and inspection readiness, and integrate GAMP principles and concepts.
The Guide builds from established guidance and key concepts from the "ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition)," the "ISPE GAMP® Guide: Records and Data Integrity," and the "ISPE GAMP® Records and Data Integrity Good Practice Guide: Data Integrity by Design."
"I see much of the pharmaceutical industry as being in the early stages of true AI and machine learning implementation," said Eric Staib, co-lead for the Guide, Secretary of the ISPE Artificial Intelligence CoP, and Vice President of Corporate Quality for Syneos Health. "There is a strong need for workforce development to help teams efficiently utilize large language models and AI-embedded systems effectively. This Guide, which aims to establish a common fit-for-use framework for industry, should help answer a lot of questions and concerns about how to approach AI systems development, monitoring, and maintenance in a structured and organized manner."
Learn more about the "ISPE GAMP® Guide: Artificial Intelligence."
About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 22,000+ members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, and technical, regulatory, and compliance collaborations in more than 120 countries worldwide. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. For more information, visit ISPE.org.
Media Contact
Katie LeChase, ISPE, +1-360-718-9771, [email protected], https://ispe.org/
SOURCE ISPE
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