GVP/VGVP Compliance & Auditing.
Compliance services for all your human & animal products.

What is GVP/VGVP Compliance & Auditing?

Common compliance requirements.

Since 2012 there has been a legal requirement for EEA Member states, the European Medicines Agency (EMA) and Marketing Authorisation Holders (MAHs) to perform audits on their Pharmacovigilance systems and quality systems supporting pharmacovigilance activities in accordance with the EMA’s Good Pharmacovigilance Practices (GVP) guidelines.

More recently the EMA introduced companion measures for Veterinary Vigilance with the Veterinary Good Vigilance Practices (VGVP) guidelines on January 28th, 2022, in line with European Union regulations (EU) 2109/6 and (EU) 2021/1281.

In most key areas the processes and requirements for GVP and VGVP are the same with both needing a Pharmacovigilance System Master File (PSMF), however there are some minor differences such as Adverse Effects Reporting (AER) timelines and Signal Management practices.

Auditing overview.

Pharmacovigilance auditing activities applicable to both GVP and VGVP, should focus on substantiating the suitability, efficiency and functioning of a pharmacovigilance system through the examination and evaluation of objective evidence, including an assessment of its quality system.

Pharmacovigilance audits should align with an approved risk-based audit program. Using suitable risk-based sampling and testing methods, auditors should identify and assess the risks for the specific area under review, and thoroughly document all their findings in an audit plan.

Click for more information from the EMA on GVP auditing.

Click for more information from the EMA on VGVP Auditing.

Supporting your GVP/VGVP Compliance & Auditing requirements.

Our GVP Compliance & GVP/VGVP Auditing & Inspections services cover the full scope of Post-marketing and Veterinary Vigilance activities across your quality assurance universe. Our auditing pool includes experienced and qualified GVP/VGVP auditors that work with the latest in regional legislation changes and requirements.

Our robust Quality Management System (QMS) can easily and efficiently adapt to the compliance needs of your marketed products. Through good communication, reliability, and trust, we aim to build a successful and strong strategic partnership across the whole life cycle of your product portfolio.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.