Avoiding Common Pitfalls in Pharmacovigilance Audits and Inspections: A Practical Guide

Pharmacovigilance (PV) audits and inspections are essential for ensuring that pharmaceutical companies maintain robust systems for monitoring drug safety. Regulatory bodies like the FDA, EMA, and MHRA conduct inspections to verify compliance with global safety requirements. However, many organisations stumble over recurring issues that can lead to inspection findings, penalties, or even product recalls.

In this blog, we’ll explore the most common pitfalls in pharmacovigilance audits and inspections and provide actionable strategies to avoid them.

1. Inadequate Documentation

The Pitfall:

One of the most frequent findings is incomplete, missing or outdated documentation. In an audit or an inspection, if it isn’t documented, it wasn’t done!

How to Avoid It:

• Follow Good Documentation Practices and maintain a centralised, well-organised and controlled documentation system.
• Ensure all contracts, agreements and procedures are regularly reviewed and updated in accordance with changes in organisation or regulatory requirements.
• Document minutes of meetings, particularly where key decisions are being made.

2. Poor Training Records

The Pitfall:

This should be one of the easiest findings to avoid, but auditors and inspectors often find that staff involved in PV activities lack up-to-date training or cannot demonstrate understanding of their responsibilities.

How to Avoid It:

• Implement a structured training program for all PV personnel and monitor training completion metrics.
• Keep detailed records of training sessions, attendance, and assessments.
• Conduct refresher courses regularly

3. Delayed or Incomplete Adverse Event Reporting

The Pitfall:

Failure to report adverse events within regulatory timelines or submitting low quality reports is a major red flag.

How to Avoid It:

• Automate reporting workflows where possible.
• Use checklists or validation rules to ensure all required data fields are completed correctly.
• Monitor submission timelines closely and set internal deadlines ahead of regulatory ones.
• Have contingency plans for staff shortages or system downtimes.

4. Oversight of Third Parties

The Pitfall:

Outsourced PV activities without proper oversight can lead to non-compliance, especially if contractual obligations are vague or missing.

How to Avoid It:

• Clearly define PV responsibilities in contracts with service providers and partners.
• Ensure regular oversight mechanisms are in place to monitor adherence with contractual obligations
• Conduct regular risk-based audits of all third-party vendors and partners.

5. Risk management and safety communication

The Pitfall:

Reference safety information (RSI) not updated in a timely manner means healthcare professionals and patients are not working with the most recent knowledge of a products safety profile.

How to Avoid It:

• Ensure any decisions to update RSI are designated a day 0 and track and monitor regularly.
• For generic medicines, ensure regular monitoring of changes made for the reference medicinal product.
• Remember to update information on any websites e.g. company website or electronic medicines compendium (emc) following any changes to the product information.

6. Inadequate Quality Management System (QMS)

The Pitfall:

A weak or poorly implemented QMS can result in systemic and recurring issues affecting the PV system

How to Avoid It:

• Establish a robust QMS with clear roles, responsibilities, and escalation pathways.
• Regularly review and update quality metrics and KPIs, including timeliness of completion of corrective actions.
• Use appropriate root cause analysis tools (e.g. 5 whys) to develop effective Corrective and Preventative Actions (CAPAs) to address any non-conformance at its core. Use effectiveness checks to confirm the issues has been properly addressed.
• Develop and follow a robust risk-based audit strategy including all internal and external parties.

7. Neglecting the Pharmacovigilance System Master File (PSMF)

The Pitfall:

An outdated or incomplete PSMF can lead to major audit/inspection findings.

How to Avoid It:

• Assign responsibility for maintaining the PSMF to a dedicated team or individual.
• Have a list of key contributors and a schedule for regular reviews and confirmation the information is accurate.
• Update the PSMF promptly following any organisational or procedural changes.
• Ensure it reflects the current compliance state of your PV system

8. Systems validation, control and Business Continuity

The Pitfall:

Systems not validated appropriately means the data held within them cannot be trusted and a lack of adequate planning for system failures can lead to significant non-compliance.

How to Avoid It:

• Identify and ensure key pharmacovigilance systems have appropriate validation documentation, and any changes made to these systems are subject to change control.
• Disaster recovery and business continuity plans should be in place and regularly tested (and documented!).

Final Thoughts

Plan, Do, Check, Improve!

Pharmacovigilance audits and inspections don’t have to be daunting. By understanding and addressing these common pitfalls, companies can build a culture of compliance and continuous improvement. Regular internal audits, mock inspections, and a proactive approach to training and documentation can go a long way in ensuring audit and inspection readiness.