How To Close And Follow Up After A CDMO Audit: Best Practices For Quality And Compliance

Closing and following up after a CDMO audit is just as important as the audit itself—and often determines whether the partnership between the customer and the CDMO strengthens or strains. Once the on‑site review ends, auditors must quickly organize their observations, document findings while details remain fresh, and prepare for a closing meeting that communicates issues clearly and constructively. A well‑executed closing meeting sets the tone for the relationship, emphasizing objectivity, professionalism, and shared commitment to quality.

After leaving the facility, the internal team debriefs to align on observations, confirm accuracy, and identify major risks or red flags. This groundwork ensures the formal audit report is comprehensive, precise, and useful for both regulatory review and long‑term quality oversight. Effective follow‑up includes prioritizing findings by risk, providing specific and actionable recommendations, setting realistic timelines, and maintaining transparent communication as the CDMO develops and implements corrective actions.

Beyond documentation and deadlines, successful audit closure depends on collaboration. Auditors who balance high standards with partnership help CDMOs understand expectations, benchmark performance, and pursue continuous improvement. By staying engaged after the audit—reviewing CAPAs, offering guidance, and planning future evaluations—organizations build trust and support compliance that benefits both parties for years to come.