Checklist for audit ready viral clearance sections in NDAs and BLAs Checklist for Audit Ready Viral Clearance Sections in NDAs and BLAs Context Viral clearance and biological safety validation are critical for ensuring the safety and efficacy of biologics, particularly those derived from human or animal sources. The regulatory landscape governing viral clearance data submissions in Biological License Applications (BLAs), New Drug Applications (NDAs), and Investigational New Drug (IND) Applications is rigorously defined by agencies such as the FDA, EMA, and MHRA. This article serves as a regulatory explainer manual, detailing the expectations surrounding the submission of viral clearance data…