Advancements in AI and Digital Transformation
ISPE established the Pharma 4.0™ operating model in 2017 through the work of the Pharma 4.0™ Special Interest Group (SIG). In 2022, recognizing the industry’s acceptance of the model and its principles, the global ISPE Pharma 4.0™ Community of Practice (CoP) was launched. Since then, the Pharma 4.0™ CoP continues to guide and enable digitalization and automation. It is organized into the following subcommittees: Holistic Digital Enablement, Plug and Produce, Digital Maturity, Management Communication Strategy, Validation 4.0, and Continued Process Verification (CPV) and Automation.
CoP members educate the industry about Pharma 4.0™ via ISPE conference sessions, webinars, and training courses. These educational offerings cover emerging practices and further application of the Pharma 4.0™ operating model. Pharma 4.0™ has extended its reach beyond North America and Europe, establishing new local ISPE Affiliate CoPs in several other countries, including Japan, Singapore, and India.
ISPE also announced ISPE AI™ and launched the global ISPE Artificial Intelligence CoP in mid-2024, which has grown to include over 2,600 members. Three AI CoP subcommittees have been organized around the following topics:
- applications, models, and data
- preparedness and workforce
- regulatory considerations
All ISPE members are welcome to join the AI CoP subcommittees. These teams discuss challenges and best practices, and share insights via ISPE publications and events.
Guidance Documents
The ISPE GAMP® Guide: Artificial Intelligence was published in July. Authored by members of the GAMP AI/Machine Learning SIG, this first-of-its-kind ISPE Guide, developed with key regulatory input, provides a much-needed framework for industry as AI-enabled systems are more widely adopted and applied.
The Guide introduces foundational AI concepts, ethical considerations, and challenges specific to pharmaceuticals and some medical devices. It also provides an AI governance framework based on GAMP concepts.
Released in December 2023, the ISPE Baseline® Guide Volume 8: Pharma 4.0™ outlines how to strategically plan the application of emerging and digital technologies with a true end-to-end focus in mind for products and processes. In recognition of their work, the authoring team received the 2024 ISPE International Honor Award for Committee of the Year. The Guide has set a new standard for industry knowledge, expanded ISPE’s influence in the industry, and continues to exemplify innovation paired with strategic alignment.
In April, ISPE published the ISPE Good Practice Guide: Digital Validation, which focuses on how increased adoption of digital validation tools in the life sciences industry can support a growing commitment to data integrity, operational efficiency, and regulatory compliance.
Membership Activities
ISPE’s focus on digital transformation and AI has enhanced the value of ISPE membership and expanded the appeal of ISPE to an extended scope of pharmaceutical professionals, namely those with information technology, information governance, and automation functions. ISPE has 20 CoPs, including the Artificial Intelligence and Pharma 4.0™ CoPs. Engagement with these topics is clear, with over 4,525 members in the Pharma 4.0™ CoP and 2,806 members in the AI CoP. The GAMP AI SIG also engages in
AI discussions. To request membership to a Special Interest Group, contact member services at ask@ISPE.org.
Conferences
ISPE’s largest conference of the year is the 2025 ISPE Annual Meeting & Expo, which will take place 26–29 October in Charlotte, North Carolina, US, and virtually. A key topic of this year’s conference will be digital transformation in the pharmaceutical industry, with 14 sessions focusing on the end-to-end implementation of digitalization across all stages of project execution, manufacturing, and regulatory processes.
The 2025 ISPE Pharma 4.0™ Conference, set for 9–10 December in Barcelona, Spain, and virtually, will explore and facilitate effective digital transformation in operations. A key highlight will be the presentation of the annual Pharma 4.0™ survey results, which will provide industry insights and benchmarks on various aspects of Pharma 4.0™. Additionally, regulators and digital transformation champions will have a significant role in this conference.
As digital transformation and AI propel the industry forward, ISPE serves as a bellwether resource for knowledge and expertise—connecting teams with valuable information, insights, and experiences that can help them strategically build, refine, fortify, and continue to evolve their approaches now and in the future.
