Sterility testing plays an essential role in sterile compounding, but testing alone cannot assure product quality. This session explores how a comprehensive approach to sterility assurance integrates Quality by Design principles with robust quality systems and validated processes. Participants will examine sterility testing methods, method suitability requirements, and the limitations of sampling when evaluating a batch. The session also addresses appropriate responses to test failures, including quarantine, root cause investigation, and corrective and preventive actions.

Sponsored by Eagle Analytics.