Preparing For A Productive CDMO Audit

Preparing for a CDMO audit is more than a regulatory requirement—it’s an opportunity to strengthen partnerships and safeguard product quality. Success begins with proactive planning. Providing a detailed agenda well in advance sets expectations and allows the CDMO to organize resources, confirm key staff availability, and prepare critical documents. Auditors should review the CDMO’s history, prior audit reports, and any outstanding corrective actions to ensure a focused and efficient process.

Clear communication is essential. Discuss compliance standards early to avoid surprises, especially when expanding into new markets or transitioning from clinical to commercial production. Both parties should understand the audit scope, time constraints, and facility requirements, such as safety gear or restricted areas. Selecting the right audit team—knowledgeable, impartial, and complementary in expertise—can significantly improve outcomes.

Ultimately, a productive audit balances thoroughness with collaboration. By approaching audits as a shared responsibility, customers and CDMOs can identify improvements, reinforce compliance, and build trust for future projects.