Pharmacovigilance
Understand exactly what inspectors look for – and the documentation you need to have ready.
Regulatory Expectations
Choose a topic below to see what inspectors check and what documents you need.
What Do Inspectors Check for Pharmacovigilance Literature Surveillance?
MAHs are expected to monitor appropriate medical and scientific literature using a defined, risk-based schedule and a justified source list.
What Do Inspectors Check in Pharmacovigilance Literature Search Strategies?
Inspectors expect literature search strategies to be documented, reproducible, and capable of identifying relevant safety information.
What Do Inspectors Check for Pharmacovigilance Literature Screening Decisions?
Literature search results must be systematically screened to identify potential individual case safety reports (ICSRs) associated with…
What Do Inspectors Check for Pharmacovigilance Literature Case Processing?
Publications identified during literature surveillance must be processed as Individual Case Safety Reports (ICSRs).
What Do Inspectors Check for Pharmacovigilance Literature Surveillance Oversight?
Literature surveillance activities should operate under defined governance and oversight processes.
What Do Inspectors Check for Pharmacovigilance KPI Governance and Oversight?
Pharmacovigilance systems should monitor operational performance through defined KPIs aligned with regulatory obligations.
What Do Inspectors Check for Pharmacovigilance KPI Design and Metric Selection?
Pharmacovigilance systems should define KPIs that monitor operational performance and regulatory compliance.
What Do Inspectors Check for Pharmacovigilance KPI Monitoring and Dashboards?
Pharmacovigilance systems should monitor performance through structured KPI dashboards and reporting tools.
What Do Inspectors Check for Pharmacovigilance KPI Review Meetings and Oversight?
Pharmacovigilance systems should review KPI performance through structured governance meetings.
What Do Inspectors Check for Pharmacovigilance KPI Escalation and CAPA?
KPI deviations must trigger escalation, investigation, and corrective action within the pharmacovigilance system.
What Do Inspectors Check for ICSR Case Management Requirements?
Pharmacovigilance systems must manage ICSRs through a structured, end-to-end process from receipt to closure.
What Do Inspectors Check for ICSR Case Intake and Source Management?
All safety information must be captured through defined intake processes.
What Do Inspectors Check for ICSR Case Data Entry and Quality Control?
ICSR data must be entered completely, accurately, and consistently into the safety database.
What Do Inspectors Check for ICSR Medical Review and Assessment?
ICSRs must undergo medical review by a qualified professional.
What Do Inspectors Check for ICSR Reporting Timelines and Submission?
ICSRs must be reported to regulatory authorities within defined timelines.
What Do Inspectors Check for Safety Data Exchange Agreement Requirements?
Pharmacovigilance responsibilities shared between companies or service providers must be governed by a defined Safety Data Exchange…
What Do Inspectors Check for Safety Data Exchange Agreement Roles and Responsibilities?
Safety Data Exchange Agreements must define roles and responsibilities clearly for all pharmacovigilance activities covered by the…
What Do Inspectors Check for Safety Data Exchange Timelines and Compliance?
Safety Data Exchange Agreements must define clear timelines for exchanging valid cases, follow-up information, and other safety data.
What Do Inspectors Check for Safety Data Exchange Reconciliation and Data Consistency?
Safety Data Exchange Agreements must require routine reconciliation of safety data between the parties.
What Do Inspectors Check for Vendor Oversight and Governance in Pharmacovigilance?
The MAH must retain ultimate responsibility for pharmacovigilance even when activities are outsourced.
What Do Inspectors Check for Vendor Qualification Requirements in Pharmacovigilance?
Pharmacovigilance vendors must be formally qualified before performing safety activities, ensuring they have the systems, expertise, and…
What Do Inspectors Check for Vendor Due Diligence and Risk Assessment in Pharmacovigilance?
Pharmacovigilance vendors must undergo documented due diligence before engagement.
What Do Inspectors Check for Vendor Selection and Approval Process in Pharmacovigilance?
Pharmacovigilance vendors must be selected through a structured and documented evaluation process.
What Do Inspectors Check for Vendor Performance Monitoring in Pharmacovigilance?
Pharmacovigilance vendors must be monitored continuously using defined performance metrics.
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