Managing Drug-Related Degradation Products

Stability storage and testing

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.