AI Algorithm Qualification for Pharma Manufacturing
How GxP-Compliant SaaS Platforms Facilitate the Process

This paper explores a Quality by Design (QbD) approach to applying Artificial Intelligence (AI) in pharma manufacturing, and demonstrates how Bigfinite’s GxP-compliant AI software-as-a-service (SaaS) platform can be leveraged to qualify AI algorithms for pharmaceutical product and medical device productivity chains.

AI algorithms have a valuable role to play in ensuring the quality of manufactured drugs and medical devices in the highly regulated global life sciences industry because they are able to manage multivariable analysis. However, because AI algorithms can be used to make critical decisions during manufacturing processes, they must be qualified to ensure that they enable established manufacturing goals. Until recently, a standard procedure to ensure such algorithm governance did not exist. Bigfinite qualified the Isolation Forest outlier detection algorithm from an agnostic perspective, enabling the resulting guidelines to be abstracted to other AI algorithms. As a result, for the first time, AI algorithms can be qualified and applied by means AI models as the foundation for decision making to leverage productivity and quality for critical processes in pharmaceutical manufacturing environments.