GVP Audits
The marketing authorisation holder in the EU is required to perform regular risk-based audit(s) of their pharmacovigilance system [DIR Art 104(2)]
Ensure your pharmacovigilance system is compliant with the GVP standards.
GVP auditors with hands-on experience in pharmacovigilance.
Independence and objectivity of auditors.
GVP Audits
Internal
GVP Audit
Processes to monitor the performance and effectiveness of a pharmacovigilance system and its quality system should include audits. Regular audit of the PV system is a mandatory requirement.
Audit
Partners / Distributors
When subcontracting tasks to another organisation, risk-based audits of the other organisation by the marketing authorisation holder or introduction of other methods of control and assessment are recommended.
Audit
Vendors and CROs
Where a marketing authorisation holder has subcontracted some tasks of its pharmacovigilance tasks, it shall retain responsibility for ensuring that an effective quality system is applied in relation to those tasks [IR Art 11(2)].