III.B.10. Quality management of pharmacovigilance inspection process

Quality of the pharmacovigilance inspection process is managed by the national competent authorities and covered by their pharmacovigilance systems and associated quality systems, meaning that the process is also subject to audit. Guidance on establishment and maintenance of a quality assured pharmacovigilance system is provided in Module I.

Quality and consistency of the inspections is facilitated by the Union procedures for pharmacovigilance inspections developed by the PhVIWG to support the mutual recognition of inspections within the EU mentioned in III.B.5.