The Need for PV Audits

The need for PV audits has evolved over the past few decades and is a now a critical tool used by pharmaceutical/biotechnology companies to ensure compliance with regulatory requirements and contractual obligations with business partners and vendors and to prepare for pending regulatory inspections. They are driven by the provision of objective evidence to verify compliance with regulations, contractual requirements, and existing procedures. PV audits in the United States are typically performed to assess the status of an internal PV departments’ activities, as part of a sponsor vendor qualification program and as part of an ongoing sponsor vendor audit program, to determine business partner/license partner compliance with the PVA or SDEA and in preparation for an expected FDA inspection. Such audits are a valuable tool to utilize as part of inspection readiness activities. Since the sponsor company is responsible for ensuring that PV activities performed internally or conducted by a contracted vendor meet the requirements as outlined in regulatory requirements, contracts, PVAs, SDEAs, and internal procedures, these audits can provide a focused evaluation of specific PV activities to identify strengths and weaknesses in PV system performance.