Good Pharmacovigilance Practice (GVP) Audit & Compliance Consulting

What are GVPs?

Good Pharmacovigilance Practices (GVP) are the standards and guidelines that describe how pharmacovigilance should be performed to make sure medicines are monitored safely and consistently, covering:

• Collecting and managing adverse event (AE) reports
• Signal detection and risk assessment
• Writing safety reports (PSUR/PBRER, RMPs, etc.)
• Inspections and quality systems
• Ensuring compliance across the product lifecycle

ProPharma provides specialized Good Vigilance Practices (GVP) readiness, compliance consulting, and pharmacovigilance (PV) audit services to support life sciences organizations operating globally in the United States, the European Union, and the APAC region. Our experts partner with clients to evaluate, design, and strengthen pharmacovigilance systems to meet regulatory expectations, ensure inspection readiness, and maintain continuous patient safety oversight.

Quality System Master File (QSMF/PSMF) Support

ProPharma provides expert support for the development, remediation, and maintenance of Quality System Master Files / Pharmacovigilance System Master Files (PSMF), including:

• Initial PSMF creation and structuring
• Gap remediation and content updates
• Alignment with EMA GVP Module II requirements
• Ongoing maintenance and inspection readiness support

We ensure documentation accurately reflects operational practice and regulatory expectations.

PV Audits & GVP Compliance Assessments

Independent, Risk-Based Audits to Ensure PV System Effectiveness and Compliance

ProPharma delivers comprehensive pharmacovigilance audit services to evaluate compliance, effectiveness, and regulatory readiness across global PV operations. Our audits are conducted by experienced PV auditors with deep regulatory and operational expertise.

Structured GVP and PV System Audits

Our audit programs are tailored to client needs and regulatory risk profiles, with a scope that may include:

• Overall pharmacovigilance system governance and oversight
• SOPs, policies, and controlled documentation
• Adverse event case intake, processing, and reporting
• Literature surveillance and safety data review
• Signal detection, evaluation, and documentation
• Aggregate reporting processes (PSUR/PBRER, safety summaries)

Audits are aligned with EMA GVP Modules, FDA expectations, and other applicable regional requirements.

Internal, Affiliate, and Third-Party PV Audits

ProPharma conducts a full range of PV audits, including:

• Internal PV audits of sponsor pharmacovigilance functions
• Affiliate audits to assess local PV implementation and oversight
• Supplier and vendor audits, including CROs, call centers, and safety service providers
• License Partner and PV Sponsor audits to evaluate contractual compliance, safety data exchange, and oversight responsibilities
• Our audits support both initial qualification and ongoing oversight programs.

Actionable Findings & Remediation Support

Audit deliverables include clear, risk-based findings, practical recommendations, and prioritized remediation actions. ProPharma can also support:

• Corrective and Preventive Action (CAPA) development
• Remediation planning and implementation
• Follow-up assessments and re-audits
• Inspection readiness and regulatory response preparation

Our Consulting & Audit Approach

ProPharma applies a consistent, inspection-focused methodology designed to deliver compliance, and confidence. Our audit approach emphasizes:

• Regulatory alignment across the US, EU, and APAC regions
• Practical, risk-based recommendations
• Collaboration with client teams to drive sustainable improvements
• Clear documentation suitable for regulatory inspection and audit defense