8 steps to successfully respond to…

Pharmaceutical companies are often inspected by competent authorities to verify the manufacturer’s compliance with regulatory requirements to ensure product safety, quality, and efficacy.

If the audit results in non-conformities or observations in a national competent authority inspection report, an EMA Establishment Inspection Report (EIR), an FDA Form 483, or a warning letter, it is critical to take prompt action to resolve the situation.

Indeed, depending on the severity, the impact of these observations can lead to crippling consequences for your company, such as fines, reputational damage, loss of market access, or even shutdown of operations.

In this blog post, we highlight 8 logical steps to respond quickly and successfully to such a situation. Implement them carefully but with sufficient speed. The time it takes to respond is quite unforgiving.

8 steps to successfully respond to non-conformities in an inspection report

Step 1: Review of the inspection report

The first step is to review the report thoroughly to understand the non-conformities listed and the legal requirements not met.

Step 2: Perform Root Cause Analysis

Conduct a thorough root case analysis. Deep dive into key aspects noted by competent authorities.

Step 3: Develop a stringent CAPA plan

Once the root cause has been identified, implement corrective actions to eliminate it and establish preventive measures to avoid its recurrence.

Step 4: Establish a Lead or Task Force

Appoint a key lead(for less serious reports) or a full task force for serious reports: identify the individuals or teams involved and create a multidisciplinary approach to involve all services.

Crucial is the selection of individuals with the necessary expertise and mandate to effectively implement the plan.

Step 5: Prioritize and sanity check CAPA plan

Prioritize and thoroughly monitor your CAPA plan: dry run the plan and track progress against the established timeline.

Plan to document all activities, including variability or changes to be made to the plan if unforeseen circumstances arise.

Step 6: Communicate with Regulatory Authorities

Keep the regulatory authorities informed of your progress and provide updates on your CAPA plan. Adhere strictly to timelines; procrastination is not an option.

Step 7: Install effectiveness checks

When the CAPA plan is complete, verify effectiveness and compliance with implementation through internal audits and data. This will provide evidence that non-conformities have been addressed and that corrective actions are effective.

Step 8: Continuously monitor critical operations

Demonstrate that you have learned to be prudent by continuously monitoring critical operations. Regularly assess quality systems and processes on a risk basis. This will sharpen your focus to identify areas for improvement and ensure ongoing compliance.

Conclusion

In short, addressing non-conformances in an EMA Establishment Inspection Report (EIR), FDA Form 483, or Warning Letter is critical to enabling your company to continue to deliver value to your patients.

Following the 8 steps listed above will give you a high-level approach to get out of this situation and demonstrate (with documented evidence) that you are managing quality according to cGMP requirements.

If you need support with audits or closing non-conformities, our experts are happy to help where needed.