Artificial Intelligence Algorithm Qualification: A Quality by Design Approach to Apply Artificial Intelligence in Pharma

Quality is defined by the American Society for Quality (ASQ) as "the totality of features and characteristics of a product or service that bears on its ability to satisfy given needs." Therefore, quality is applicable to processes that supply outcomes with values that can be measured. Statistical control is an effective methodology that provides the outcome of quality of goods, bringing an added value that other methods, like quality by inspection, do not offer. The statistical methods applied to process control have been thoroughly developed, and the mathematics that supports them have been broadly demonstrated. Artificial Intelligence (AI) is a field in which mathematics, statistics, and programming play a joint role, and its results can also be applied to disciplines like quality control. Nevertheless, its utilization is subordinate to the qualification of the implemented algorithms. This research presents a standard procedure to AI algorithms, allowing their usage in regulated environments to ensure the quality of the delivered products or services (e.g., in drugs and medicines manufacturing). The regulated principles are defined by the concept of quality by design (QbD), which is a notion introduced in the pharmaceutical industry as a good practice for process management under multivariate analysis. This study intended to provide guidance for qualifying AI algorithms using QbD guidelines as the foundation for this purpose.