Shared Qualification Audits: A Win-Win-Win Approach

By Enith Morillo

In November 2021, the FDA published an update to the Resiliency Roadmap for FDA Inspectional Oversight, sharing the agency’s success in grappling with the impact of COVID-19 on domestic and foreign inspections and its effective use of remote interactive evaluations to support surveillance activities.

Throughout the pandemic, the agency has demonstrated more than ever the value of using a risk-based approach to inspectional activities, which must be embraced and mirrored in industry when it comes to supplier and vendor audits, especially by early-stage pharmaceutical companies.