Vision Inspection Software And USP <790>: Safeguarding Quality In Parenteral Drug Manufacturing

Ensuring injectable drug products are free of visible particulates is a critical quality and safety mandate for parenteral drug manufacturers and CDMOs. USP <790> sets the regulatory benchmark, requiring validated inspection processes and continuous monitoring. While manual inspection remains widespread, its limitations—variability, subjectivity, and inefficiency—are driving adoption of vision inspection software. These systems offer high-speed imaging, defect classification, and full data traceability, aligning with 21 CFR Part 11 and Annex 11 requirements. By digitizing inspection records and integrating with MES and LIMS platforms, manufacturers can meet ALCOA+ principles and eliminate paper-based risks. For CDMOs, robust inspection capabilities not only ensure compliance but also serve as a competitive differentiator. As regulatory expectations evolve, scalable software platforms position organizations for future readiness.

Explore how vision inspection software supports consistent compliance, operational efficiency, and patient safety.