Forced degradation studies to assess the stability of drugs and products

• Global regulatory status of forced degradation studies.
• Critical appraisal of official requirements.
• Benefits of stress testing in assessing drug and product stability.
• Executing a study meeting regulatory expectations in Quality by Design environment.
• Selective examples of detailed reports in the literature.

A forced degradation study is an essential step in the design of a regulatory compliant stability program for both drug substances and products, and was formalized as a regulatory requirement in ICH Guideline Q1A in 1993. It has since been extended to generic drugs. We provide an update on world-wide regulatory requirements. Also, we list all possible benefits of forced degradation studies to assess the stability of drugs and products. We discuss the kind of forced degradation study likely to meet regulatory expectations. We include the knowledge gained from these studies within the Quality by Design paradigm.