Impurity profiling is mandatory in the manufacturing process of pharmaceutical products. The presence of impurities could affect the quality and safety of drug products posing health risks to patients due to their potentially carcinogenic or immunogenic effects. The large number and variety of potential impurities presents a significant analytical challenge for their detection, quantification, and characterization.
The webinar aims to provide an overview of the regulatory framework related to the impurities in pharmaceutical products and the latest updates in the field of Extractables & Leachables and Nitrosamines.
These topics will be addressed from the perspective of the toxicologist, who has the delicate responsibility of assessing the toxicity of these impurities and, therefore, the safety of the pharmaceutical product.
The main focus will be the management of the laboratory output and how to deal with the challenges of assessing impurities.