Audit & Assurance
Good Pharmacovigilance Practice Audits
Specialist pharmacovigilance system audits for marketing authorisation holders, covering PSMF integrity, QPPV oversight, ICSR processing and vendor qualification, aligned to EMA GVP Modules and EU PV legislation.
Executive Overview
Pharmacovigilance, the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of medicinal products, is a legal obligation for all marketing authorisation holders operating in the EU and UK. The regulatory framework is extensive, covering signal detection, benefit-risk assessment, expedited reporting, periodic safety updates and the maintenance of a functioning pharmacovigilance system.
EMA GVP Modules (I through XVI) set detailed requirements across all aspects of pharmacovigilance. National competent authorities and the EMA conduct pharmacovigilance inspections to verify that MAHs have implemented these requirements in practice. The consequence of significant pharmacovigilance deficiencies includes marketing authorisation restrictions, suspension and referral procedures.
Sthira Assure pharmacovigilance audits are conducted by specialists with operational experience of PV system management, PSMF maintenance, vendor oversight and regulatory inspection outcomes. We provide structured assessment of PV system compliance at the level of specificity required to identify systemic risks before they generate regulatory consequences.
Regulatory Frameworks
- EMA GVP Modules I–XVI
- EU Directive 2010/84/EU
- EU Regulation 1235/2010
- UK Human Medicines Regs
- ICH E2 Series
- FDA 21 CFR Part 314
Common Compliance Risks
PSMF Accuracy and Currency
The Pharmacovigilance System Master File must accurately describe the actual pharmacovigilance system in operation. Inspectors consistently find discrepancies between PSMF descriptions and operational reality, particularly in relation to IT system descriptions, vendor arrangements and key personnel records. An inaccurate PSMF is a serious regulatory finding regardless of whether the underlying PV system functions adequately.
QPPV Structural Control
The QPPV must have continuous access to all safety information and demonstrable oversight of the pharmacovigilance system. Regulators assess whether QPPV oversight mechanisms are operational, not simply documented. Inspectors look for evidence that the QPPV receives and acts on information from affiliates, vendors and local PVQA personnel.
Outsourced Activity Oversight
The majority of MAHs outsource significant pharmacovigilance activities to specialist safety vendors. EMA GVP Module I requires that MAHs maintain oversight of all outsourced activities and that written agreements clearly define responsibilities. Inspectors find that oversight is frequently limited to SLA monitoring rather than quality-focused assessment of actual vendor performance.
ICSR Timeline Compliance
Expedited reporting timelines for serious unexpected adverse reactions are non-negotiable regulatory requirements. Systematic failures to meet 7-day or 15-day reporting timelines, or to correctly classify cases as expeditable, result in significant regulatory findings. These failures are often systemic rather than isolated and reflect weaknesses in case intake and triage procedures.
Scope of Services
Common Audit Findings
These represent frequently observed findings during GVP system audits of marketing authorisation holders. They reflect systemic gaps that independent audit routinely identifies before pharmacovigilance inspection.
Frequently Asked Questions
Who is required to comply with EMA GVP Modules?
Marketing authorisation holders for medicinal products authorised in the EU are required to comply with EMA GVP Modules in respect of all centrally and nationally authorised products. The Qualified Person responsible for Pharmacovigilance (QPPV) must hold an EU/EEA resident address and be registered with the relevant national competent authority. Organisations holding only nationally authorised products comply with national CA requirements, which are aligned to the EU GVP framework.
What must a Pharmacovigilance System Master File contain?
The PSMF must describe the pharmacovigilance system in sufficient detail to verify its adequacy — including QPPV details and responsibilities, description of the PV organisational structure, computerised systems used for ICSR processing and signal detection, sources of safety data, the scope of outsourced activities and relevant vendor details, quality management provisions and an audit log. The PSMF must be kept current and must accurately describe the system in operation, not an aspirational system.
How frequently should a pharmacovigilance system be audited?
GVP Module I requires that a pharmacovigilance system audit programme is maintained and that audits are conducted at risk-based intervals. There is no fixed minimum frequency, but regulators expect that major PV processes and outsourced activities are assessed periodically. Organisations subject to EMA inspection should ensure that a comprehensive PV system audit has been conducted within the past three years, with more frequent assessment of identified risk areas or following significant changes to the PV system.
Can pharmacovigilance audits be conducted remotely?
Remote GVP audits are viable for document-intensive assessments including PSMF review, SDEA compliance checking, ICSR sample reviews and aggregate report process assessments. Onsite assessment is recommended for vendor and affiliate audits where operational observation adds significant assurance value. Hybrid formats are available for complex scopes where part of the assessment benefits from direct observation.
Request a GVP Audit
Speak with our pharmacovigilance specialists about your PV system assurance requirements.