Protect Patients And Ensure Regulatory Compliance With Robust Impurity Control

By Dujuan Lu, Extractable & Leachable Manager and Global Leader, SGS Pharma

The impurity control strategy you leverage throughout manufacture of your pharmaceutical is critical to patient safety and drug efficacy. Extractables and leachables (E&Ls), nitrosamines, and per- and polyfluoroalkyl substances (PFAS) are all common – and potentially genotoxic – impurity types that must be accounted for. To protect patients, impurities must be controlled to levels that comply with designated regulatory thresholds; this requires a comprehensive approach.

By accounting for impurities early in process development, your team can better avoid delays down the road and uphold your intended timeline to market. This also helps ensure a robust submission package with thorough impurity testing and control data. If you are looking for guidance in your journey to reliable impurity control, consider the benefits of working with an experienced partner. Download the full article to learn about the risks of E&Ls, nitrosamines, and PFAS, and the importance of state-of-the-art equipment and impurity testing experience as means to ensuring their continued control.