Pharmacovigilance, regulated by the 16 GVP modules, is one of the most complex areas for Regulatory Affairs and Pharmacovigilance Specialists. Inspections can come at short notice and affect sensitive areas such as PSUR management, Risk Management Plans (RMPs) , and Signal Management .
The most common errors include incomplete PSURs, lack of evidence in RMP implementation, and poor traceability in signal detection decisions.
A best practice is to prepare a PV Inspection Readiness Kit with updated SOPs, team training records, partner contracts, and quality checks on case reports.
Our Pharmacovigilance Guide from GuideGxP provides operational checklists, PSUR and RMP templates, and real-life inspection cases to help you prepare comprehensively.
Download the guide to be prepared for your next inspection without any surprises.
