During a pharmacovigilance audit, the FDA may review a range of documents and data related to the company’s pharmacovigilance activities, such as:
Standard operating procedures (SOPs) and work instructions related to pharmacovigilance
Adverse event reports and related documentation, such as case processing forms and medical reviews
Risk management plans (RMPs) and related documents
Safety data exchange agreements (SDEAs) with partners or vendors
Training records for pharmacovigilance personnel
Inspection findings and corrective and preventive action (CAPA) plans
Any other relevant documentation related to pharmacovigilance activities.
The FDA may also conduct interviews with pharmacovigilance personnel and other stakeholders to gather additional information and clarify any issues that arise during the audit.
The purpose of a pharmacovigilance audit is to assess the effectiveness of a company’s pharmacovigilance system and ensure compliance with relevant regulations and guidelines. The FDA may issue observations or warning letters based on the findings of the audit, and may require the company to take corrective action to address any deficiencies identified during the audit.