The Role of Risk-Based Audit Planning Under EU GVP Module IV
A risk-based audit system is a regulatory requirement under EU GVP Module IV and a key tool for maintaining oversight and ensuring GVP compliance. It ensures that audits are planned and conducted based on a structured risk assessment, rather than following fixed intervals.
Risk, in this context, refers to the likelihood of non-compliance with pharmacovigilance obligations and the potential impact such non-compliance may have on patient safety, data integrity, or regulatory responsibilities.
Marketing Authorisation Holders (MAHs) are required to:
Identify all PV-relevant entities and processes (the audit universe) - including internal departments, critical PV processes, affiliates, service providers, and licensing partners,
Assess their risk level using objective, predefined criteria (e.g. complexity, criticality, compliance history),
Classify them into risk categories (e.g. high, medium, low),
And prioritise audits accordingly within a documented strategic and tactical audit plan.
→ See how I support you implementing your audit strategy
The strategic audit plan outlines long-term objectives and ensures that all relevant entities are covered within a defined timeframe (typically at least once every five years). It is a dynamic document, reviewed and adjusted as part of the annual risk assessment update. The tactical audit plan specifies which audits are to be conducted in the short term, based on current priorities.
Risk-Based Audit System in Pharmacovigilance
Ensure GVP Compliance and Effective Oversight
To ensure compliance, the entire audit planning process must be clearly documented and justified - including the risk assessment methodology, the rationale for prioritisation, and any deviations from the strategy - all in line with the expectations of EU GVP Module IV. These expectations are further pointed out in Commission Implementing Regulation (EU) No 520/2012, which reinforces the requirement for a structured, risk-based audit approach and highlights the importance of audit planning as a central element of pharmacovigilance system oversight and patient safety.
This risk-based approach supports regulatory compliance by ensuring that high-risk areas, such as critical PV processes, high-impact partners, or local affiliates are audited with appropriate frequency and oversight.
My Services
Building and Maintaining
Your Risk-Based PV Audit System
Developing an EU GVP-Compliant Audit Strategy
Designing a structured and GVP-compliant audit framework that reflects your PV system setup and operational model. This includes aligning the strategy with applicable timelines and ensuring coverage of all PV-relevant entities and activities.
Defining For-Cause Audit Triggers in Pharmacovigilance
Defining specific triggers for for-cause audits (e.g., significant compliance issues or inspection findings) and embedding them into the audit governance framework to ensure prompt and compliant responses.
Risk Assessment Criteria for PV Audit Prioritisation
Establishing clear and measurable criteria (e.g. criticality, complexity, compliance history) to support transparent risk scoring, audit justification, and defensible decision-making - including the setup of for-cause audit triggers where relevant.
Strategic and Tactical Audit Plans for PV Oversight
Developing long-term (strategic) and short-term (tactical) audit plans based on structured risk evaluation - ensuring your audit universe is covered appropriately and priorities are regularly re-evaluated.
Ensuring Inspection-Readiness Through Audit Documentation
Ensuring full traceability and inspection-readiness of audit planning documents - including risk assessments, audit schedules, prioritisation rationale, and justifications for any deviations from the defined strategy.
I support you in building and maintaining a compliant, risk-driven PV audit system that aligns with both EU GVP Module IV requirements and your organisation’s operational realities - covering internal PV processes as well as external entities:
✔ Regulatory Compliance
Fulfil your obligation to implement a risk-based audit system in line with EU GVP Module IV - with traceable, inspection-ready documentation.
✔ Targeted Use of Resources
Prioritise audits where the risk is highest - whether at critical PV partners, internal processes, or affiliates - and reduce unnecessary audit activities.
✔ Cost-Effective Remote Audits
Implement remote audits where appropriate, based on risk assessments, to reduce costs and enhance flexibility, aligning with current regulatory guidelines.
✔ Improved Planning & Oversight
Establish a transparent, long-term audit strategy with dynamic updates and measurable risk criteria - ensuring strong, proactive risk mitigation.
✔ Risk-Based Oversight for Greater Assurance
Avoid blind spots in your PV system by establishing a structured audit plan that adapts to your organisation’s evolving risk profile.
Your Benefits
From Smarter Planning to Stronger Regulatory Oversight
Need expert support in implementing a risk-based PV audit system?
I provide tailored support to help you develop a compliant and effective audit system - from defining risk criteria to setting up strategic and tactical plans.
Contact me to strengthen your audit strategy and meet GVP expectations with confidence.
© 2025 Jessica Dyck | Privacy Policy | Legal Notice