Pharmacovigilance Audit Checklist

A Pharmacovigilance (PV) Audit Checklist serves as a structured tool for evaluating the adequacy and effectiveness of a Pharmacovigilance system and its associated quality framework. The purpose of PV audits is to identify gaps and ensure compliance with regulatory requirements and best practices. This checklist facilitates systematic verification of processes, governance, and documentation within PV systems. It supports organizations in maintaining robust safety monitoring mechanisms, ensuring timely reporting, and upholding patient safety.

Category	Sub-Categories / Items to Check
Oversight by Marketing Authorization Holder	Safety governance
Roles and Responsibilities	QPPV roles and responsibilities
Local PV Department	Responsibilities and organization
Back-Up Procedures	Ensure existence and effectiveness
Quality Management Systems	Procedures, Quality Assurance, Quality Control, Record retention
Staff	Training and records, Job descriptions, Qualifications, PV experience, Non-PV staff involvement
SOPs	Including cross-functional SOPs
Case Processing	Individual AEFIs processing, Regulatory submissions
Aggregate Reports	PSURs/Annual Reports, Timely submissions to NRA
Signal Management	Signal identification and evaluation
Risk Management	Risk Management Plans (RMPs) and updates
Urgent Safety Issues	Crisis management, Handling urgent safety issues
Safety Inquiries	Responses to NRA inquiries
Safety Database	Review and evaluation
Literature Searches	Adequacy and documentation
Medical Information	Accuracy and management
Compliance Metrics	Review of compliance indicators
Labeling	CCDS/CCSI, SPC, PIL, Process for updates and implementation
Contracts for External Services	Content and management
Contracts with Partners	Co-marketing, Co-development, Co-manufacturing
Archiving	Archiving procedures and compliance

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