Preparing for Pharmacovigilance Audits: Best Practices for Compliance

Why Pharmacovigilance Audits Matter

Pharmacovigilance audits are critical for ensuring compliance with global regulatory requirements for drug safety monitoring. These audits are typically conducted by regulatory authorities such as the FDA, EMA, or MHRA to assess whether a company’s pharmacovigilance system meets the necessary standards for collecting, processing, and reporting adverse events. Failure to comply can result in significant fines, warnings, or even product recalls.

At Viltis, we help companies prepare for pharmacovigilance audits by implementing best practices and ensuring that your drug safety systems are audit-ready at all times.

Best Practices for Preparing for a Pharmacovigilance Audit

1. Comprehensive Documentation: One of the most common pitfalls in pharmacovigilance audits is inadequate documentation. Ensure that all safety data, adverse event reports, risk management plans, and standard operating procedures (SOPs) are up to date, clearly documented, and easily accessible. This includes records of all adverse events, periodic safety update reports (PSURs), and any signal detection activities.

2. Audit Trail: Regulatory bodies will often review how well safety data is tracked and maintained. Make sure that your pharmacovigilance database maintains a clear audit trail that captures any changes made to data, including who made the changes and why.

3. Training Records: Auditors will check whether all relevant personnel have received appropriate pharmacovigilance training. Ensure that all training records are current and that staff can demonstrate an understanding of safety reporting requirements.

4. Global Regulatory Compliance: If your drug is marketed in multiple countries, ensure that your pharmacovigilance system is compliant with the regulations of each country’s health authority. This includes variations in reporting timelines, the format of submissions, and safety data collection requirements.

5. Mock Audits: Conduct mock audits to simulate the real audit experience. These dry runs help identify weaknesses in your pharmacovigilance system before the actual audit and provide an opportunity to correct any deficiencies. Viltis offers mock audit services to ensure you’re fully prepared.

Common Pitfalls to Avoid

• Incomplete Adverse Event Reports: Ensure that all adverse event reports include required information, such as patient details, drug names, outcomes, and the reporter’s credentials. Missing information is one of the most common audit findings.
• Delayed Reporting: Regulatory bodies have strict timelines for reporting adverse events. Missing these deadlines can lead to audit findings and penalties.
• Inconsistent Data: Ensure that data in the pharmacovigilance system is consistent across all reports. Discrepancies between case reports, risk management plans, and other documents can raise red flags during an audit.

Addressing Audit Findings

If an audit identifies gaps or areas for improvement, it’s important to act swiftly. Corrective and Preventive Actions (CAPA) plans should be developed and submitted to regulatory authorities within the prescribed timeframe. These plans outline how the company will address the deficiencies and prevent them from recurring.