IMS Pharmacovigilance: WHO TRS 986, 21 CFR 211

Pharmacovigilance carries an inspection burden of its own, and this Integrated Management System is built for the Marketing Authorisation Holders and pharmaceutical companies who have to carry it. GMP expectations, FDA 21 CFR Part 211, ISO 9001, ISO 22301, ISO 31000 and ALCOA+ are drawn into one safety-governance framework covering the full drug-safety lifecycle, with an IMS manual and policy setting safety accountability and a QPPV office defined through the leadership, roles and responsibilities procedure.

The procedures follow the work as it is actually done: individual case safety report management and expedited reporting, aggregate safety reports covering PSUR, PBRER and DSUR, signal detection and management, literature monitoring, pharmacovigilance agreements and external provider oversight, data integrity and computerised systems, deviation and CAPA, internal audit and business continuity of PV operations. The adverse event intake form, case processing and submission log, signal tracking log, literature search record and partner tracker leave a trail behind each safety decision, while checklists mirror the modules regulators inspect — ICSR quality review, ALCOA+ self-inspection, BCP activation and an inspection readiness gap review. Guidance sets out the pharmacovigilance regulatory framework, good documentation practice and an integration and compliance matrix across the standards.