Types of PV Audits

Preapproval audits are Pharmacovigilance (PV) audits conducted in preparation for an FDA preapproval inspection (PAI). FDA PAIs can be scheduled but are often unannounced meaning they can just “show up” at an organization’s office location during the period by which the organization is awaiting an approval decision on a sponsor product marketing authorization application (MAA). Routine PV audits are audits conducted within the scope of the sponsor organization’s risk-based audit vendor program. The frequency and scope of routine PV audits vary depending on contracted activities. PV vendor qualification audits are audits performed by the sponsor as part of their vendor management program which is typically part of the organization’s quality management system (QMS) in collaboration with the functional area subject matter experts (SME). Business/license partner audits are sponsor audits of business or license partners who are involved in the identification, exchange, management, reporting, and communication of safety information. These audits fall within the overall annual audit plan and can be conducted on a routine basis (based on the identified risk to the sponsor organization) or as part of a for-cause audit.