The Critical Role of Robust Visual Inspection Test Sets in Biologics Drug Product Manufacturing

For parenteral drug products, visual inspection (VI) is a critical quality control measure to detect particulate contamination and packaging defects. Whether manually or through (semi)-automated approaches, effective VI depends on well-trained operators and appropriately qualified equipment. This white paper provides a technical overview of regulatory expectations and best practices for visual inspection test set design, manufacture, certification, and lifecycle management.