A New Baseline for Global GMP Oversight

The FDA’s decision to expand unannounced inspections to all foreign manufacturing sites marks a major shift in global quality oversight. In this paper, Helen Kargaryani, VP Global Head of Quality Assurance at SSI Strategy, examines what the change means for sponsors, CDMOs, and quality leaders. She outlines how to sustain readiness every day, not only during inspections, and the operational, cultural, and strategic steps that support continuous compliance.