Updating viral safety risk assessments after process change and new data Updating Viral Safety Risk Assessments After Process Change and New Data The field of regulatory affairs continuously evolves, particularly concerning viral clearance and biological safety validation. A key component in this realm is the viral safety risk assessment, which ensures the safety of biological products through a structured evaluation of potential viral contaminants. Regulatory professionals face the challenge of maintaining these assessments as dynamic, living documents that reflect process changes and new data throughout the product lifecycle. Context A viral safety risk assessment serves to identify, evaluate, and manage…

Bridging historic viral safety risk frameworks to new ICH Q5A expectations Bridging historic viral safety risk frameworks to new ICH Q5A expectations The pharmaceutical and biotechnology industries are increasingly required to align their practices with evolving regulatory frameworks. Specifically, the viral safety risk assessment process has experienced significant transformation with the introduction of the ICH Q5A guidelines. This article serves as a comprehensive regulatory explainer manual, detailing the relevant regulations, guidelines, agency expectations, and best practices for conducting viral safety risk assessments in accordance with both historical frameworks and the latest ICH guidance. Context of Viral Safety Risk Assessments Viral…