How do you verify CAPA after a GMP audit?

1 Identify the root cause

The first step to verify CAPA is to identify the root cause of the nonconformity or gap. This means analyzing the problem, collecting data, and using appropriate tools and methods to find out the underlying factors that led to the issue. You need to identify the root cause accurately and clearly, as this will determine the scope and nature of your CAPA.

2 Define the CAPA plan

The next step is to define the CAPA plan, which should include the corrective action taken to eliminate or reduce the nonconformity or gap, as well as a preventive action for long-term prevention of recurrence. The responsible person or team should be specified, along with a timeline that sets out deadlines and milestones. The verification criteria should also be outlined, providing expected outcomes and measures of success.

3 Implement the CAPA plan

The third step is to implement the CAPA plan according to the defined responsibilities and timeline. You need to follow the GMP principles and procedures, and document all the steps and results of your CAPA. You also need to communicate and coordinate with the relevant stakeholders, such as the auditors, regulators, customers, and suppliers, to ensure alignment and transparency.

4 Verify the CAPA results

The fourth step is to verify the CAPA results using the verification criteria. You need to collect and analyze data, such as records, reports, tests, inspections, feedback, and audits, to evaluate whether your CAPA have achieved the desired outcomes and resolved the nonconformity or gap. You also need to compare the actual results with the baseline data and the audit findings, and identify any discrepancies or deviations.

5 Monitor and review the CAPA effectiveness

The final step is to monitor and review the CAPA effectiveness over time. To do this, you need to establish and implement a monitoring and review system, which should take into consideration the risk and severity of the nonconformity or gap, as well as the complexity and impact of the CAPA. Additionally, you should use relevant and reliable indicators and methods to assess the performance and sustainability of the CAPA. Lastly, feedback and improvement mechanisms should be put in place to collect stakeholder feedback and identify any improvement opportunities for your CAPA. By following these steps, you can verify CAPA after a GMP audit to ensure compliance with GMP requirements and quality standards.

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?