Process Analytical Technology (PAT) Model Lifecycle Management

Abstract

Many applications of process analytical technologies (PAT) use spectroscopic measurements that are based on prediction models. The accuracy of the models can be affected by a number of factors such as aging equipment, slight changes in the active pharmaceutical ingredient (API) or excipients, or previously unidentified process variations. Because models are living documents and must reflect the changes in the process to remain accurate, the models need to be updated and managed. This summary describes how one major pharmaceutical company approaches the challenges of managing these models.