Isabelle VuTrieu, Pharmaceutical Market Development Manager, Waters Corp.
Genotoxic Impurities. Dr. Phil Borman, Director of Product Quality at GSK, provided this response when asked where he applies the lifecycle management approach. As Phil explained in the first episode of the MLCM podcast series1, complex methods that require a tight control of the critical quality attributes are opportunities to leverage the lifecycle management approach. Taking a risk-based approach, Phil’s team identifies methods designed to detect genotoxic impurities as ones with potential control issues, which require stringent controls. They are absolutely critical for the patients.” He continues “[We] focus our efforts on critical parts of our product control strategy to make sure those methods are of a high standard so the patient is confident that these are not present, or exist at very low limits of a process”