GVP / Pharmacovigilance Audits

Overview

Pharmacovigilance systems must ensure that safety information is collected, assessed, documented, reported, monitored, and managed in accordance with applicable regulatory requirements.

Mediature GxP Solutions Pvt. Ltd. (MGS) provides independent pharmacovigilance audit and assessment services for Marketing Authorization Holders, pharmaceutical companies, CROs, service providers, and other organizations involved in drug-safety activities.

Our audits evaluate pharmacovigilance systems, processes, responsibilities, documentation, computerized systems, vendor oversight, safety reporting, signal management, literature monitoring, aggregate reporting, and quality controls.

MGS follows a practical, risk-based approach to identify compliance gaps, strengthen PV systems, and support readiness for regulatory inspections and partner audits.

Our Pharmacovigilance Audit Services

PV System Audits

Assessment of the overall pharmacovigilance system, governance, roles and responsibilities, procedures, oversight, quality controls, and regulatory compliance.

ICSR Process Audits

Review of case intake, validity assessment, data entry, coding, narrative preparation, medical review, quality review, follow-up, seriousness assessment, expectedness, causality, and reporting.

Regulatory Reporting Audits

Assessment of safety-reporting processes, timelines, submission controls, acknowledgements, reconciliation, and compliance with applicable reporting requirements.

Literature Monitoring Audits

Evaluation of literature-search strategy, search frequency, databases, screening, documentation, case identification, full-text review, and reporting controls.

Signal Management Audits

Assessment of signal detection, validation, prioritization, assessment, documentation, escalation, decision-making, and risk-management actions.

Aggregate Reporting Audits

Review of PSUR/PBRER, DSUR, and other applicable periodic safety-reporting processes, data sources, review controls, timelines, and documentation.

Safety Database Audits

Assessment of safety-database configuration, user access, workflow, validation, coding dictionaries, audit trails, data integrity, backup, security, and electronic reporting.

SDEA / PVA Audits

Review of Safety Data Exchange Agreements and Pharmacovigilance Agreements to assess roles, responsibilities, timelines, reconciliation, escalation, and compliance monitoring.

PSMF Audits

Assessment of Pharmacovigilance System Master File content, maintenance, accuracy, supporting documentation, system description, and alignment with actual PV activities.

Vendor & Service Provider PV Audits

Independent assessment of outsourced PV service providers, CROs, literature vendors, database vendors, call centers, and other partners performing safety activities.

Pre-Inspection & Mock PV Audits

Simulated pharmacovigilance inspections to identify potential system gaps and prepare teams, documentation, and processes for regulatory inspection.

Key Audit Focus Areas

Depending on scope, MGS may assess:

• PV governance and organizational structure
• Roles and responsibilities
• PVOIC / QPPV-related responsibilities, where applicable
• Case intake and validation
• ICSR processing
• Seriousness, expectedness, and causality assessment
• Medical and quality review
• Follow-up management
• Regulatory reporting timelines
• Literature monitoring
• Signal management
• Aggregate reporting
• Risk management
• Safety database controls
• MedDRA and coding practices
• SDEA / PVA management
• Reconciliation processes
• PSMF maintenance
• Vendor oversight
• SOPs and controlled documents
• Training and competency
• Deviations and CAPA
• Change control
• Audit trail and data integrity
• Business continuity
• Compliance metrics
• Inspection readiness

Applicable Pharmacovigilance Perspective

Depending on the client’s products, markets, and responsibilities, audit criteria may consider applicable requirements and expectations associated with:

• Good Pharmacovigilance Practices
• ICH pharmacovigilance guidelines
• Applicable national pharmacovigilance requirements
• Marketing Authorization Holder obligations
• Safety-reporting requirements
• Data-integrity expectations
• Computerized-system requirements
• Applicable contractual and safety-data-exchange obligations

The final audit criteria are defined according to the client’s regulatory market, product portfolio, PV system, and contractual responsibilities.

Our Audit Process

• Define Scope

Understand the PV system, products, regulatory markets, outsourced activities, agreements, previous findings, and audit objectives.

• Prepare

Review available documentation and develop a risk-based audit plan focused on critical PV processes and compliance risks.

• Conduct

Perform on-site or remote assessment through interviews, document review, case sampling, system review, process evaluation, and evidence verification.

• Evaluate

Assess observations based on their potential impact on patient safety, regulatory reporting, data integrity, system compliance, and business risk.

• Report

Provide a structured audit report with observations, supporting evidence, compliance significance, and recommended improvement areas.

• Follow Up

Where required, support CAPA review, remediation planning, effectiveness checks, and follow-up audits.

Audit Deliverables

Depending on the agreed scope, MGS can provide:

• Audit agenda and audit plan
• PV system assessment
• Process-specific review
• ICSR sample review
• Detailed audit report
• Observation summary
• Risk-based observation classification
• Compliance-gap assessment
• CAPA review support
• Inspection-readiness recommendations
• Follow-up audit support

Why Choose MGS for Pharmacovigilance Audits

End-to-End PV Understanding

Our audit approach covers the full pharmacovigilance lifecycle, from case intake and reporting through signal management, aggregate reporting, risk management, agreements, and system governance.

Operational & Quality Perspective

MGS combines practical PV operations experience with quality-system and compliance assessment.

Risk-Based Methodology

Audit focus is directed toward areas with the greatest potential impact on patient safety, regulatory compliance, data integrity, and reporting obligations.

Practical Findings

Observations are communicated clearly so clients can understand the gap, its significance, and the area requiring corrective action.

Vendor & Partner Oversight

We can assess both internal PV systems and outsourced activities performed by CROs, vendors, partners, and service providers.

Inspection Readiness

MGS can support clients from gap assessment through remediation, mock inspection, team preparation, and follow-up review.

Who We Audit

MGS can support pharmacovigilance audits of:

• Marketing Authorization Holders
• Pharmaceutical companies
• Pharmacovigilance departments
• CROs
• Safety database vendors
• Literature-monitoring vendors
• Medical information providers
• Call centers receiving safety information
• Business partners
• Contract service providers
• Other organizations performing outsourced PV activities