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Pharmacovigilance Compliance Checklist 2026

  • 04-12-2024
  • Posted by: Eldaniz Hasanov
  • Category: Uncategorized
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Pharmacovigilance Compliance Checklist 2026

Updated 15 July 2026. This practical checklist supports MAH audit and inspection readiness and should be adapted to products, countries and applicable GVP rules.

Governance

  • QPPV and local contacts appointed with back-up;
  • roles, escalation and management oversight documented;
  • delegated activities remain under MAH oversight.

PSMF and procedures

  • PSMF reflects actual products, territories, systems and agreements;
  • SOPs are consistent, current and followed in practice;
  • records have owners, retention rules and version control.

ICSR processing

  • all intake channels are covered and tested;
  • validity, seriousness, expectedness and causality are assessed consistently;
  • follow-up, duplicate checks, MedDRA coding and submissions are timely;
  • reconciliation covers medical information, complaints, studies and partners.

Signals and risk management

  • signal sources, frequency and methods are justified;
  • validation, prioritisation, assessment and closure are traceable;
  • the RMP reflects the current benefit–risk profile;
  • risk-minimisation effectiveness is evaluated.

Aggregate reports and studies

  • PSUR/PBRER and DSUR schedules are controlled;
  • data, exposure and signals are internally consistent;
  • PASS and RWD studies have protocols and quality controls;
  • regulatory commitments are tracked to closure.

Quality system

  • role-based training is timely and effective;
  • KPI/KRI identify delays and trends;
  • deviations have root-cause analysis and effective CAPA;
  • risk-based audits cover critical vendors and processes;
  • computerised systems are validated and access controlled.

Inspection readiness

  1. Appoint an inspection coordinator and team.
  2. Prepare current PSMF, organisation chart and system inventory.
  3. Test rapid document retrieval.
  4. Run a risk-based mock inspection.
  5. Track requests and submitted evidence.
  6. Implement sustainable CAPA after inspection.

Official sources

How PharmExpert can help

PharmExpert provides gap assessments, mock inspections, vendor audits and CAPA, PSMF and SOP support.

This checklist does not replace jurisdiction-specific requirements.