Managing drug-related degradation products
Listen to Dr. Mark Powell as he discusses managing drug-related degradation products. Drug-related degradation products are often the shelf-life limiting attribute during stability studies. This webinar details current regulatory guidance and strategies for justifying impurity levels greater than the default limits in ICH Q3B. Impurity guidance for biologics is less well developed than for chemical drugs, but relevant guidance will be covered. The webinar goes on to address common problems with stability-indicating test methods and challenges in trending impurities, including dealing with data above the method’s limit of detection but below the limit of quantitation.
Topics covered include:
- Introduction and definitions
- Regulatory expectations for ordinary and genotoxic impurities
- Strategies for impurity justification/qualification
- Trending degradation products – how to avoid common problems
This webinar also contains a brief introduction to our new cGMP facility in Belgium from our General Manager, Cecile Jacoby.
Guest speaker
Dr. Mark Powell, Director at MP Scientific
Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for analytical development and equipment qualification.
In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes as well as establishing collaborations with academia and instrument manufacturers. In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits.
He is in demand as a trainer in topics such as chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies, method validation, extractables and leachables, and root cause analysis.