Pharmacovigilance Audits

Training and Consultancy

The legal requirement for auditing

Pharmacovigilance audits are a regulatory necessity worldwide and an integral part of a Marketing Authorisation Holder’s (MAH’s) pharmacovigilance quality system. MAHs must conduct regular and planned audits to evaluate their pharmacovigilance system’s compliance with current regional and local legislation such as the EU’s Good Pharmacovigilance Practices (GVP) guidelines.

Pharmacovigilance audits need to be independently conducted and must cover all aspects of the pharmacovigilance system, including its outputs and the quality management system in place. The findings from PV audits should be fully documented, with deficiencies identified and remedies addressed through Corrective and Preventive Actions Plans (CAPAs).

This planned and structured approach to maintaining patient safety and meeting regulatory requirements also extends to a MAHs operational and outsourced partners and their own internal affiliates and processes.

Failure to comply with these regulatory requirements can lead to severe consequences, including legal actions, financial penalties, and reputational damage, and of course it can compromise patient health and safety.

Typical auditing activities.

The audit process covers and connects with a variety of areas and activities including:

In-depth Pharmacovigilance Audits (on-site or remote): Internal PV audits, targeted process audits (e.g. signal management, safety variations, ICSR management, etc.), PV audits on behalf of a client company.

Inspection Readiness: Tailored guidance and training for organisations to ensure their readiness for pharmacovigilance regulatory inspections.

Audit Report: The preparation of an audit report with an evaluation of the audit findings’ criticality and proposed actionable recommendations.

Audit Certificate: The issue of a formal certificate upon successful completion of the audit process, providing assurance of compliance, diligence, and commitment to pharmacovigilance excellence.

Follow-Up: Planning, overseeing, and providing support for CAPA plans in response to PV audits or inspections

Audit Program Management: Designing, overseeing, and refining a structured PV audit program alongside developing systematic tools for effective auditing.

iVigee Difference

iVigee’s audit team consists of senior PV auditors with years of auditing experience and important feedback gained from multiple PV inspections by various health authorities.

That experience allows us to provide practical examples of authority expectations, even when published PV guidance is hard to interpret. In addition, we use our world leading Regulatory Intelligence platform iViReg to ensure our approach is based on the latest PV relevant regulations in over 90 countries.

We believe in a tailored approach to PV audits, recognizing that each company has its unique challenges and needs. Our team works closely with you to develop customised audit strategies that address specific objectives, risk areas, and compliance goals, and our proactive approach involves not just identifying current compliance gaps but also anticipating future challenges, ensuring that our clients are always one step ahead in PV compliance.

Following an audit our auditors provide a structured audit report and give clear, actionable feedback on the findings. We can also support you with the CAPA preparation and management required to ensure your audit findings are implemented and evaluated.

iVigee is committed to the highest standards of ethical integrity and confidentiality, ensuring that all data and findings from audits are handled with the utmost care and discretion, building trust through a secure partnership. We work collaboratively with you to implement effective solutions, ensuring open and transparent communication throughout the audit process.