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)].

GVP Audits

GVP Audits

Internal GVP Audit

Audit Partners / Distributors

Audit Vendors and CROs

Internal
GVP Audit

Audit
Partners / Distributors

Audit
Vendors and CROs