How to Close and Follow Up After a CDMO Audit: Best Practices for Quality and Compliance

Auditing ensures quality assurance of a cGMP Contract Development and Manufacturing Organization (CDMO). The customer makes a big decision when considering partnering with a CDMO to manufacture its drug product. The product managers commit time, money, reputations, and sometimes careers to this decision. Unforeseen market delays and production costs caused by the CDMO directly affect the company’s profitability. This is a risky decision, and the audit is just one part of the total evaluation of the CDMO.

The audit process doesn’t end when investigators complete their final facility walkthrough. The closing and follow-up phase is just as critical as the audit itself. Both the customer (auditor) and the CDMO (host) benefit as regulatory compliance of the CDMO generally increases. Difficulties arise when the CDMO’s standard of performance and motivations collide with the customer’s expectations. How auditors handle the final stages determines whether they build a productive partnership or create unnecessary friction.

​​Closing out a cGMP audit with a Contract Development and Manufacturing Organization (CDMO) requires transforming findings into lasting process improvement.

Organize Your Findings Immediately

Auditors should organize their observations while the details are fresh in their minds. The end of an audit day starts a crucial window of opportunity. This immediate documentation prevents the losing critical details once investigators leave the facility. This includes:

• Going over all of the audit’s notes and photos
• Sorting results according to severity (critical, major, or minor observations)
• Comparing observations to corporate standards and legal requirements
• Making an initial list of the main issues

Prepare for the CDMO audit closing meeting

The closing meeting represents the auditor’s opportunity to present findings clearly and professionally. This meeting often determines whether the CDMO views the audit as a constructive partnership or a confrontation. Auditors should:

• Start their presentation with positive observations and then address concerns
• Offer specific examples for each finding
• Prepare for questions the CDMO might ask about the observations
• Decide which team members will present different sections of the findings

Conduct a professional closing meeting with the CDMO

The closing meeting sets the tone for the relationship moving forward. Effective auditors recognize that hosting an audit is disruptive to normal operations and requires significant effort from staff. Auditors should:

• Begin with an acknowledgment of the CDMO’s cooperation
• Present findings objectively without accusatory language
• Allow the CDMO to ask questions and provide context for observations
• Avoid making definitive decisions about the partnership during this meeting
• Thank the CDMO team for their time and transparenc

  Organize Your Findings Immediately

  Auditors should organize their observations while the details are fresh in their minds. The end of an audit day starts a crucial window of opportunity. This immediate documentation prevents the losing critical details once investigators leave the facility. This includes:

  • Going over all of the audit’s notes and photos
  • Sorting results according to severity (critical, major, or minor observations)
  • Comparing observations to corporate standards and legal requirements
  • Making an initial list of the main issues

  Prepare for the CDMO audit closing meeting

  The closing meeting represents the auditor’s opportunity to present findings clearly and professionally. This meeting often determines whether the CDMO views the audit as a constructive partnership or a confrontation. Auditors should:

  • Start their presentation with positive observations and then address concerns
  • Offer specific examples for each finding
  • Prepare for questions the CDMO might ask about the observations
  • Decide which team members will present different sections of the findings

  Conduct a professional closing meeting with the CDMO

  The closing meeting sets the tone for the relationship moving forward. Effective auditors recognize that hosting an audit is disruptive to normal operations and requires significant effort from staff. Auditors should:

  • Begin with an acknowledgment of the CDMO’s cooperation
  • Present findings objectively without accusatory language
  • Allow the CDMO to ask questions and provide context for observations
  • Avoid making definitive decisions about the partnership during this meeting
  • Thank the CDMO team for their time and transparency

  Internal Audit Team Debrief

  After leaving the CDMO facility, the audit team needs time to process what they observed. This internal debrief should:

  • Allow each team member to share their overall impressions
  • Identify any conflicting observations that require reconciliation
  • Assess whether the audit revealed any unexpected red flags
  • Discuss the CDMO’s responsiveness to questions and concerns during the audit

  Structured Audit Feedback to the CDMO

  The formal audit report represents the official feedback mechanism. Regulatory agencies may review these reports during inspections, and quality personnel will reference them for years when evaluating supplier performance. This report should:

  • Document all significant observations with specific locations, dates, and evidence
  • Distinguish between regulatory non-compliances and internal standard gaps
  • Provide clear descriptions that allow the CDMO to understand and address each finding
  • Maintain a professional, objective tone throughout

  Maintain Two-Way Communication with the CDMO

  Effective auditors understand that feedback is mutual. The best customer-CDMO relationships develop when both parties commit to ongoing improvement. Auditors should be receptive to the CDMO’s explanations of their observations and encourage them to share their thoughts on the audit process.  Certain “findings” might be the result of misunderstandings rather than real issues.

Prioritize Findings by Risk

Not all observations carry equal weight, and treating every finding as equally critical overwhelms CDMOs and delays meaningful improvement. Auditors should help the CDMO focus their remediation efforts by:

• Clearly identifying which issues pose the highest risk to product quality or regulatory compliance
• Distinguishing between issues that require immediate correction versus longer-term improvements
• Recognizing which observations represent systemic problems versus isolated incidents
• Considering the CDMO’s resource constraints when setting expectations for corrective actions

Create Specific, Actionable Recommendations

Vague findings frustrate CDMOs and delay improvements. Strong recommendations should describe a specific issue, explain why it matters for product quality or compliance, and suggest concrete steps the CDMO can take to address the problem.

Set Timelines and Expectations for CDMO Corrective Actions

Both parties need clarity about next steps to avoid confusion and maintain momentum. The follow-up plan should:

• Set reasonable deadlines for the CDMO to respond with corrective action plans
• Define what constitutes an acceptable response (e.g., root cause analysis, preventive actions, timeline for implementation)
• Specify when the customer expects to see evidence of completed corrections
• Determine whether certain findings require a follow-up audit or if documentation review will suffice

Document Everything

The audit follow-up creates a record that both parties may reference for years. This documentation protects both organizations if questions arise during regulatory inspections or if the partnership encounters challenges down the road. Documentation should track all commitments and agreed-upon timelines, maintain copies of all correspondence, and create a clear audit trail that demonstrates due diligence.

Balance Thoroughness with Partnership

Two auditors who separate the engineering and process areas from the quality system achieve the most successful audits. These auditors, familiar with the relationship between the technical and quality groups and experienced in their fields, work through the agenda far more quickly. A two-auditor team also provides opportunities for some good cop, bad cop dynamics to reach a consensus with the CDMO on a sticking point.

Auditors should remain cooperative throughout the process and recognize that the CDMO hopes to succeed in manufacturing high-quality products. Avoid using the relationship manager for the CDMO as an auditor due to their incentive structure. Present results as opportunities for improvement rather than as failures.

Provide Constructive Context

CDMOs benefit when auditors provide a more thorough overview rather than only pointing out flaws. Auditors can explain how the CDMO’s practices compare to industry standards and point out areas where the CDMO shows excellence. When appropriate, auditors can acknowledge the challenges specific to contract manufacturing and provide insights from audits of other similar facilities without violating confidentiality.

Stay Engaged Beyond the Audit

The relationship continues long after auditors file the audit report. Regular communication shows that auditors remain invested in the CDMO’s success. Organizations should respond promptly to CDMO questions, review corrective action plans and provide feedback, recognize when the CDMO successfully addresses findings, and share frequent updates about quality metrics and performance.

Plan for the Future

Partnership requires ongoing attention and planning. Both parties should establish a schedule for follow-up audits or quality reviews, create a system for the CDMO to proactively communicate potential issues, build relationships throughout both organizations, and revisit and update quality agreements as products and processes evolve.

The audit closing and follow-up phase can serve as the foundation for a long-term partnership. When auditors approach this phase with clarity and collaboration, they improve regulatory compliance and product quality, while fostering relationships that benefit both organizations for years to come.