An Informatics Based Approach to Developing a Stability Indicating Method
Peter Russell, Dmitry Mityushev, Petr Kandalov, Andrew Anderson, Anne Marie Smith
Abstract: During drug development, a large amount of time and effort is spent on chromatographic method development. The work product of this development is a Stability Indicating Method (SIM)-a validated analytical procedure used to measure the active ingredients in the drug substance or drug product, separate from any process impurities, excipients or degradation products.
The efficient development of a Stability Indicating Method requires a complete understanding of the manufacturing process and efficient communication between various interrelated departments, from process chemistry through to analytical research and development. These groups are often located in different locations globally and have their own internal systems for capturing information, with the most common means of communication being Excel or PowerPoint documents. These documents are not purpose built for communicating such complex data and may leave results open to interpretation.
In this presentation, we will discuss an informatics system which captures structural, analytical and process related data in a structured and searchable manner to facilitate inter and intra departmental communications. Using such a system allows Quality by Design principles to be extended to the drug development process, leading to a safe, effective and well qualified product.