Audit & Inspection Readiness

Ongoing state of PV systems, documentation, and training such that an inspection can be supported at any time without last-minute preparation.

Observation or deficiency raised during a regulatory PV inspection; may be critical, major, or minor. Requires CAPA and follow-up.

Qualified Person for Pharmacovigilance; responsible for the PV system in the EU (and similarly in other regions). Must be resident and contactable.

Document describing the MAH's PV system (structure, processes, resources). Required in EU and must be kept up to date and available for inspection.

Systematic action to correct a deviation or finding and prevent recurrence; required for quality and inspection findings.

Documented procedure describing how a PV activity is performed; must be followed, trained on, and kept current.

Training of PV personnel on procedures and regulations; competency assessed and documented. Key for inspections.

Contracting PV activities to third parties; MAH remains responsible. Must be governed by agreement and oversight.

Request from authority for data, analysis, or action (e.g., signal assessment, list of cases); must be answered within deadline.

Topics and systems covered in a PV inspection (e.g., case processing, signal detection, QPPV, outsourcing).

Verification that a CAPA has been effective (e.g., no repeat deviation); required to close CAPA.

Contract governing PV responsibilities between MAH and partner (e.g., licensee, CRO); defines who reports what and how.

One-off request from authority for data or analysis (e.g., list of cases, signal review).

Document issued by authority after inspection listing findings and sometimes recommendations.

Inspection finding indicating critical breach (e.g., data integrity, patient safety); requires immediate action.

Significant deficiency that could affect PV system; requires CAPA and follow-up.

Deficiency that does not significantly affect PV; should be corrected.

Inspection to verify that previous findings have been addressed.

Internal or external simulation of an inspection to test readiness and identify gaps.

List of documents requested by inspector at start or during inspection.

Dedicated space for inspectors with access to documents and systems; logistics support inspection.

Designated person who can act when QPPV is unavailable; must be qualified and documented.

Ability to receive and triage urgent safety issues (e.g., fatal, recall) at any time; often via on-call or hotline.

Internal or external audit of PV system and processes; distinct from regulatory inspection.

Audit of outsourced PV vendor (CRO, database vendor) to ensure compliance.

Agreement defining quality responsibilities between MAH and contractor (e.g., CRO).

Process for escalating issues (e.g., serious case, inspection, crisis) to appropriate level.

Question or request from authority (e.g., list of cases, signal assessment); must be answered on time.

Plans to maintain PV activities during disruption (e.g., system failure, pandemic).

Description of PV system (in PSMF or equivalent); structure, processes, resources.