Why do pharmacovigilance audits matter?
- Jackie Roberts
- Jun 18
- 2 min read
When it comes to medicines, every tablet, injection, and cream carries a promise—a commitment to helping to treat, alleviate, and improve lives. But behind the scenes, a meticulous process ensures that these promises hold true. Enter pharmacovigilance audits, the silent guardians of drug safety, ensuring regulatory compliance and protecting patients from unexpected risks.
I think of pharmacovigilance audits as the ultimate quality control checkpoint in the pharmaceutical world. They identify weaknesses, improve processes, and ensure that pharmaceutical companies adhere to international safety standards like Good Pharmacovigilance Practices (GVP).
Behind the Curtain: How Audits Unfold
A pharmacovigilance audit isn’t just about ticking boxes on a checklist—it’s a deep dive into adverse event reporting systems, risk management plans, and patient safety protocols. Here’s what we do, as auditors, in a typical audit:
Planning Phase: We gather intelligence, reviewing past reports, regulatory filings, and known risks associated with the drug or with the company’s portfolio. We ask to see SOPs, company reports, previous inspection reports so that we understand the company and know where to focus our investigations. Whatever the customer, whether a pharmaceutical company or contract research organization (CRO), we scrutinize data management systems, signal detection practices, and compliance procedures.
Interviews & Documentation Review: Either in person or remotely we question pharmacovigilance professionals, healthcare teams, and regulatory specialists to verify processes.
Risk Identification & Recommendations: We look for weaknesses to flag, non-compliances to highlight and corrective measures to propose.
Follow-Up & Compliance Tracking: After the audit, we provide a report for companies to produce a CAPA plan and to ensure that compliance is maintained. We can also assist with follow up and compliance tracking.
Recent Trends: AI & Automation in Audits
Pharmacovigilance audits are evolving rapidly. Artificial intelligence (AI) and automation are revolutionizing pharmacovigilance by enhancing real-time signal detection, automating case processing, and simplifying compliance tracking. Ensuring that the systems used are validated and fit for purpose are key areas in any audit.
The Stakes Are High
History has shown that pharmacovigilance failures can have devastating consequences. From the thalidomide disaster of the 1960s to unexpected cardiac risks in COX-2 inhibitors, audits can be critical in preventing tragedies before they unfold. When conducted effectively, pharmacovigilance audits protect lives, strengthen trust, and ensure medicine remains a force for good.
Final Thoughts
Pharmacovigilance audits may not grab headlines, but I really think they are the unsung heroes ensuring that every prescription filled, every drug approved, and every treatment prescribed meets the highest safety standards. Next time you pick up medication, remember—the work of pharmacovigilance experts is what makes it possible.
At PharmaGuard we can undertake pharmacovigilance audits on behalf of clients, ensuring good practices are embedded into processes. Whether it is a full pharmacovigilance system audit, a product specific audit or a process related audit we are here to support you and your teams. Please contact us for more information.
