Quality

Regulatory trends What Today’s Regulatory Signals Are Really Telling Industry The FY2024 Report on the State of Pharmaceutical Quality presents a picture of a U.S. drug supply that is broadly stable but increasingly complex, with regulatory oversight intensifying in response to post-pandemic realities and emerging risk patterns. FDA oversight activity rebounded strongly after COVID-19 disruptions, with a substantial increase in both domestic and foreign inspections and the highest-ever use of Mutual Recognition Agreement partner inspections, reflecting a more globalized and risk-based surveillance approach. FDA Is Inspecting More And Looking Deeper Across Global Supply Chains FDA has fully restored and expanded its inspection footprint, with a sharp increase in foreign and risk-based inspections. Inspection frequency is up, expectations are higher, and FDA is connecting site performance, product quality signals, and supply chain data in real time. How Vertentis Helps:We prepare your organization to withstand more frequent, more data-driven inspections—including readiness for foreign supplier oversight, MRA-informed inspections, and cross-site traceability reviews. Our approach ensures your quality story is inspection-ready before FDA asks the question. REPORT 2024 Report on the State of Pharmaceutical Quality Download the Report FDA Is Targeting OTC, API, and Compounding-Linked Supply Chains FDA enforcement is no longer evenly distributed. OTC monograph manufacturers and API suppliers, especially those supporting compounding are under heightened scrutiny, with aggressive use of records requests, remote assessments, and import alerts. How Vertentis Helps:We help clients identify and close hidden risk in OTC, API, and supplier oversight programs, strengthening data integrity, testing strategies, supplier qualification, and response readiness. Vertentis ensures you are prepared not just for inspections, but for pre-inspection records requests and rapid compliance decisions. FDA Expects Fewer Failures, Because It Believes Quality Systems Should Prevent Them Despite increased inspections, FDA reported fewer recalls and stable postmarket quality outcomes, signaling a clear expectation: mature quality systems should prevent failures, not react to them. How Vertentis Helps:Vertentis moves organizations beyond “inspection survival” toward inspection confidence—embedding risk-based quality management, proactive CAPA, stability intelligence, and lifecycle oversight. We help you demonstrate to FDA that quality is designed into your system, not managed after the fact. In short, FDA inspections are evolving. Vertentis ensures your quality systems evolve faster—so inspections confirm confidence, not expose gaps.