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Risk-Based Assessment for PV Audits for the US FDA, EMA and MHRA

Risk-Based Assessment for PV Audits

Risk-Based Assessment framework for pharmacovigilance audits showing process, vendor, product, regulatory, and technology risks

🔎 Risk-Based Assessment for PV Audits and Vendor qualification (Due diligence): When & how to perform them?

Most pharmacovigilance (PV) audit programs fail not because they are incomplete, but because they attempt to audit everything equally. In today’s complex regulatory environment, this approach no longer works. Regulators expect organisations to demonstrate risk awareness, prioritisation, and proactive oversight—not just audit coverage.

This is where Risk-Based Assessment (RBA) becomes critical. RBA is no longer optional for global pharmacovigilance leaders; it is now the foundation of inspection readiness and sustainable compliance.

At GPLACO SOLUTIONS, our RBA methodology has supported Chief Risk Officers, QPPVs, and Senior Quality & Compliance leaders across the US and EU, helping them design audit programs that predict compliance gaps before inspections occur.

Why Traditional PV Audits Fall Short

Conventional audit models focus on static schedules and uniform scope. However, modern PV systems operate across multiple regions, partners, products, and technologies. This complexity introduces uneven risk distribution, which traditional audits fail to address.

Regulators increasingly ask:

  • Why was this area audited now?

  • How did you prioritise high-risk partners?

  • Where is the evidence of ongoing oversight?

A structured RBA framework provides these answers.

The Five Core Risk Pillars for PV Audits

A mature RBA model evaluates risk across five critical domains:

1. Process & Operational Risk
This includes ICSR quality, late reporting trends, CAPAs, signal detection effectiveness, and RMP performance. Weak operational controls remain a primary source of inspection findings.

2. Partner & Vendor Risk
CROs, affiliates, distributors, license partners, and safety database providers introduce delegated risk. New partnerships, high-volume vendors, and those with prior findings require enhanced oversight.

3. Product & Portfolio Risk
High-risk therapeutic areas such as oncology, biologics, gene therapy, and products with REMS or boxed warnings demand deeper audit focus, especially during early launch phases.

4. Geographical & Regulatory Risk
The US, EU, UK, and Japan maintain the highest regulatory expectations. Markets with evolving regulations or limited local PV maturity also require targeted audits.

5. Technology & System Risk
New safety database implementations, EDC integrations, data migrations, and AI-driven automation introduce compliance risk if not validated and governed appropriately.

Why RBA-Driven Audits Deliver High ROI

Risk-based audits transform PV quality systems from reactive to preventive:

  • Resources are focused where real regulatory consequences exist

  • Findings are reduced by addressing root causes early

  • Governance, QPPV accountability, and partner oversight improve measurably

  • Inspection readiness is strengthened with fewer audits, not more

Build Your PV Audit Strategy with Intelligence

At GPLACO SOLUTIONS, we design Risk-Based Assessment for PV Audits (RBA)-driven annual audit programs for the US FDA, EMA & MHRA covering Strategic, Tactical and Operational audits:

• Strategic level audit planning resulting in an audit strategy (long term approach), which should be endorsed by upper management;

• Tactical level audit planning resulting in an audit programme, setting audit objectives, and the extent and boundaries, often termed as scope, of the audits in that programme; and

• Operational level audit planning resulting in an audit plan for individual audit engagements, prioritising audit tasks based on risk and utilising risk-based sampling and testing approaches, and reporting of audit findings in line with their relative risk level and audit recommendations in line with the suggested grading system.

  • SDEA / PVA oversight

  • Vendor and global partner audits

  • PSMF and RMP evaluation

  • Safety database and system validation

  • Affiliate and PVQA governance

🔐 Connect with us to implement a Risk-Based Assessment for PV Audits and global PV audit strategy tailored to your portfolio, regions, and regulatory exposure.

GPLACO Solutions can help you with :

  • Pharmacovigilance audit strategy focused on Risk-based PV audits, Vendor qualification/Due Diligence audits, Global PV compliance, PV inspection readiness, Vendor oversight pharmacovigilance and PVQA and risk management.

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