Pharmacovigilance is vital when it comes to ensuring the safety and efficacy of medicinal products from development all the way to the end of the life cycle. A pharmacovigilance audit is the systematic and objective examination of the pharmacovigilance system within a company aimed at evaluating whether the pharmacovigilance activities meet all the regulatory requirements, internal guidelines, and global safety standards.

What Is a Pharmacovigilance Audit?

A pharmacovigilance audit is the process of evaluation of pharmacovigilance systems, processes, documentation, and safety activities performed by a pharmaceutical company or service provider. In other words, its purpose is to check whether the system works effectively and complies with the pharmacovigilance regulations of EMA, FDA, and other international agencies.

Pharmacovigilance audits can be carried out by internal auditors, external auditors, and regulatory bodies. This type of audit is an integral part of the quality management system and must be performed in order to provide a complete Pharmacovigilance System Master File (PSMF).

Objectives of a Pharmacovigilance Audit

Key objectives of conducting the audit are:

• Ensuring compliance with pharmacovigilance regulations;
• Evaluation of the proper collection, assessment, and reporting of adverse events;
• Evaluation of pharmacovigilance quality management system performance;
• Identifying risks and gaps;
• Patient and product safety;
• Inspection preparation.

Scope of Pharmacovigilance Audits

The scope of a pharmacovigilance audit could include the following pharmacovigilance activities:

• AE reporting and processing
• Signal generation and risk management
• Periodic safety update reports (PSURs)
• Risk Management Plans (RMPs)
• Lit surveillance
• Pharmacovigilance agreement or contract
• Training and qualifications
• Data management and safety databases
• Pharmacovigilance System Master File (PSMF)
• Vendor/third party pharmacovigilance activities 

Different Types of Pharmacovigilance Audits

The different types of pharmacovigilance audits include:

• Internal Audits

Internal audits can be performed by the audit or quality assurance team of the organization for ensuring internal process compliance according to the procedures established by the organization itself and the regulatory agencies.

• External Audits

External audits can be performed by partner companies, service providers, or any third party organization to ascertain whether there is compliance with the terms of agreement or with the regulatory requirements.

• Regulatory Authority Inspection

An inspection by the regulatory authority to check the compliance of a pharmaceutical company with its pharmacovigilance obligations can also be considered an important type of pharmacovigilance audit.

Pharmacovigilance Audit Process

Typically, the pharmacovigilance audit process is comprised of:

• Audit Planning Define the scope, objectives, audit plan, and audit team.
• Document Review Review SOPs, safety reports, training records, and compliance documentation.
• Audit Execution Conduct interviews, review case processing, and evaluate pharmacovigilance activities.
• Audit Findings Identify and classify findings such as critical, major, and minor findings.
• Audit Report Prepare and issue the audit report with observations and recommendations.
• CAPA Management Implement Corrective and Preventive Actions (CAPA) to address audit findings.
  
  
  

Follow-up Audit Verify that CAPA actions have been implemented and are effective.

Common Audit Findings in Pharmacovigilance

Some of the typical audit findings involve:

• Late adverse events reporting
• Insufficient case data
• Unsatisfactory SOPs and outdated procedure documentations
• Absence of training documentations
• Poor documentation practices
• Unsatisfactory PSMF
• No oversight of vendors
• Insufficient signal detection documentation

Importance of Pharmacovigilance Audits

Pharmacovigilance audits are essential for maintaining compliance, ensuring patient safety, and improving pharmacovigilance systems. They help organizations identify risks early, improve processes, and avoid regulatory penalties. Regular audits also help companies remain inspection-ready at all times.

Conclusion

A pharmacovigilance audit is an essential component of a pharmaceutical companys quality and compliance framework. It ensures that drug safety activities are conducted according to regulatory requirements and that patient safety is always prioritized. By conducting regular pharmacovigilance audits, organizations can maintain compliance, improve their pharmacovigilance systems, and ensure the safe use of medicinal products worldwide.

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By Shara Najimudeen, Digital Marketing Executive, GLC Europe, Colombo Office, Sri Lanka.