Purity is a Virtue: A Practical Guide to the Reporting of Impurities

Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and how to include them in their regulatory applications. This webinar is designed to increase the understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take away messages. We will start by defining the various types of impurity and then delve into each of the guidance documents. To demonstrate application of this knowledge, we will present a few relevant case studies in which impurities were successfully investigated and reported in marketing applications.