PT  - JOURNAL ARTICLE
AU  - Stassen, Mario
AU  - Leitao, Catarina S.
AU  - Manzano, Toni
AU  - Valero, Francisco
AU  - Stevens, Benjamin
AU  - Schmucki, Matt
AU  - Hubmayr, David
AU  - Mirabent Rubinat, Ferran
AU  - Dessoy, Sandrine
AU  - Moreira, Antonio R
TI  - Recommendations for Artificial Intelligence Application in Continued Process Verification
AID  - 10.5731/pdajpst.2024.012950
DP  - 2024 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2024.012950
4099  - http://journal.pda.org/content/early/2024/12/27/pdajpst.2024.012950.short
4100  - http://journal.pda.org/content/early/2024/12/27/pdajpst.2024.012950.full
AB  - This review paper explores the transformative impact of Artificial Intelligence (AI) on Continued Process Verification (CPV) in the biopharmaceutical industry. Originating from the CPV of the Future project, the study investigates the challenges and opportunities associated with integrating AI into CPV, focusing on real-time data analysis and proactive process adjustments. The paper highlights the importance of aligning AI solutions with regulatory standards and offers a set of comprehensive recommendations to bridge the gap between AI's potential and its practical, compliant, and safe application in pharmaceutical manufacturing. Emphasizing transparency, interpretability, and risk management, the research contributes to establishing best practices for AI implementation, ensuring the highest quality pharmaceutical products while meeting regulatory expectations. The conclusions drawn provide valuable insights for navigating the evolving landscape of AI in pharmaceutical manufacturing.