Pharmacovigilance Audits and Inspections

Explore how pharmacovigilance audits use a systematic, independent, documented process to obtain and evaluate evidence. Identify how audit objectives verify effectiveness of the pharmacovigilance quality system and ensure compliance.

Learn a risk-based approach to pharmacovigilance audits, prioritizing strategic, tactical, and operational planning to safeguard patient safety and public health through targeted audits, risk assessment, and graded findings.

Address audit outcomes by conducting root cause analyses and implementing corrective and preventive actions. Ensure timely, monitored follow-up with documented evidence and keep governance informed of progress.

Explore independent pharmacovigilance audits within a robust quality system and record management, ensuring objectivity, documented scopes, and clear governance, including outsourced audits and report retention.

Explore pharmacovigilance inspections, their legislative basis, and how authorities assess marketing authorisation holders’ compliance through PV system master file reviews and findings (critical, major, minor).

Explore pharmacovigilance system and product related inspections, including routine and for cause triggers. Learn about pre- and post-authorization reviews, announced or unannounced inspections, reinspections, and remote approaches.

Plan pharmacovigilance inspections with a systematic, risk-based approach to optimize surveillance and resources, define scope and triggers, and guide re-inspections based on prior findings and PV system changes.

Harmonize EU pharmacovigilance inspections through planned, coordinated processes from planning to follow up, with CAPA-driven actions, information sharing, and regulator communication to address non-compliance.

Inspectors for pharmacovigilance inspections are appointed by member states or the CHMP based on experience and national requirements. They receive training in pharmacovigilance processes and reporting.

Review the MHRA pharmacovigilance inspection metrics for 2021–22, including findings by topic, inspection arms, and the distribution of critical, major, and minor findings.

Learn the role of auditors and inspectors, and the difference between audits and inspections, plus key pharmacovigilance topics like the risk management plan, PSMF, and QPPB.