The US Food and Drug Administration (US FDA) has stated that, “AI offers many possibilities in the pharmaceutical industry, including but not limited to optimizing process design and process control, smart monitoring and maintenance, and trend monitoring to drive continuous improvement. The use of AI to support pharmaceutical manufacturing can be deployed with other advanced manufacturing technologies to achieve desired benefits. AI is an enabler for the implementation of an Industry 4.0 paradigm that could result in a well-controlled, hyper-connected, digitized ecosystem and pharmaceutical value chain for the manufacturer.”
ISPE is uniquely positioned to aid the industry in realizing the potential of AI in the pharmaceutical industry through identifying and bringing forth best practices, liaising with regulatory bodies, and communicating lessons learned and case studies with relevant stakeholders. Additionally, as a thought leader in GAMP® and Pharma 4.0™ principles, ISPE has the additional scope necessary to realize the AI-enabled digital transformation of the industry.
To codify efforts, ISPE is in the process of establishing a new Community of Practice (CoP) focused on the AI topic area. This CoP will join the existing 20 ISPE Global Technical CoPs that engage and collaborate on topics important to professionals in the pharmaceutical industry. Additionally, the new CoP will amplify the scope and efforts of the ISPE GAMP® Artificial Intelligence/Machine Learning Special Interest Group, which has been an active contributor to the industry’s adoption of these technologies since 2019.
The primary operating groups of ISPE Global CoPs are the Steering Committees, which are made up of subject matter experts (SMEs) particular to each specific CoP topic. CoP Steering Committees meet monthly, develop, and deliver on ISPE content generation plans, and are provided the opportunity to be recognized as industry leaders in their specific areas of expertise. Content generated includes ISPE Guidance Documents, Pharmaceutical Engineering® magazine articles, webinars, educational materials, and conference content.
The new AI CoP Steering Committee will address relevant topics such as the regulatory aspects of AI, guidance on applications of AI throughout the pharmaceutical lifecycle, organizational preparedness for implementation of AI, benchmarking, workforce education and skills development, and organizational impacts.
ISPE is currently seeking SMEs in the application of AI to the pharmaceutical industry. SME volunteers are needed to establish the new AI CoP Steering Committee, as well as to take on the leadership roles of Chair, Co-Chair, and Secretary.
ISPE members interested in being considered for membership or leadership of the newly forming ISPE AI CoP Steering Committee, please send an email to: communities@ispe.org.
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