AI Algorithm Qualification: A QbD Approach to Apply AI in Pharma

This paper has been accepted by the PDA Journal of Pharmaceutical Science and Technology and published in the Jan/Feb 2021 journal. 

This study demonstrates that artificial intelligence (AI) algorithms can be qualified for pharmaceutical product and medical device productivity chains. AI algorithms are extremely valuable to the highly regulated life sciences and healthcare industries because they can be used to make critical decisions during drug and medical device manufacturing processes. However, AI algorithms must first be qualified to ensure that they enable established manufacturing goals. Until now, such a procedure did not exist in GxP environments.

Manufacturing decision making that is informed by qualified AI algorithms can potentially lower costs and increase profitability related to pharmaceutical and medical device production. Leveraging AI as a multivariate tool can help optimize processes, as well as predict and fix anomalies in industrial environments. As a result, products and devices that are safer, more efficient and effective, and of higher quality can be made accessible to patients and healthcare providers.

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