An Approach to Pharmaceutical Impurity Data Life Cycle Management Based on Informatics
Graham A. McGibbon, Andrew A. Anderson, Joe DiMartino, and Carol Preisig
Abstract: Applying Quality by Design (QbD) principles to impurity investigations and control strategies requires a thorough understanding of the manufacturing process. The drug development lifecycle is lengthy and complicated, often with multiple stakeholders, often in disparate locations around the globe. During the process, a vast array of complex and heterogeneous data is collected and transferred between the various project teams. Chromatography data from multiple detectors (e. g. LC/UV and LC/MS) along with associated identifications, inevitably comprises a substantial extent of this essential data. Many groups have their own systems for capturing data, but no single centralized system linking information together. There is a significant need for informatics systems that manage impurity information including all this data. We describe a system with tools that allowed collation, analyses and review of mass spectrometry data irrespective of the originating hardware and assembly of those results together with other impurity knowledge. The result is a living/working tool that can grow over the pharmaceutical lifecycle-from discovery, through development, and to drug launch-and allowing the visualization of many discrete process-related variables in a single, searchable interface. Incorporation of user feedback into the emerging software during the development process has also been an important aspect of this new approach.