Conducting A CDMO Audit Day Efficiently: Practical Strategies

Conducting a CDMO audit day efficiently is essential for safeguarding timelines, costs, and compliance. Success begins with building the right team—ideally two auditors with complementary expertise in quality systems and technical processes. This approach ensures balanced coverage, faster progress, and effective consensus-building. Strategic agenda planning is equally critical: prioritize areas that directly impact profitability, such as compliance gaps, high-risk operations, and contractual misalignments.

Preparation sets the tone for a productive audit. Review regulatory guidance, recent FDA-483 observations, and the CDMO’s performance history. Create documentation templates and coordinate responsibilities with your co-auditor to streamline the process. During the audit, establish clear expectations early, maintain professional balance, and use open-ended questions to foster collaboration. Real-time documentation of findings, responses, and agreements prevents misunderstandings and supports actionable follow-up.

Avoid common pitfalls like misjudging CDMO maturity, overlooking cultural differences, poor time management, and losing objectivity. When unexpected challenges arise—such as major compliance gaps or resistance to findings—respond factually, consult with your team, and seek consensus before escalation. Ultimately, an organized, well-executed audit strengthens regulatory compliance, protects profitability, and builds trust for long-term success.