GVP/VGVP Auditing & Inspections.
Compliance support for marketed human and animal products.

What are GVP/VGVP Auditing & Inspections?

The need for pharmacovigilance Auditing & Inspections.

Regulatory requirements mandate that Marketing Authorisation Holders (MAHs) have a legal obligation to conduct GVP & VGVP Auditing on pharmacovigilance activities conducted with their marketed human or animal products.

This includes the pharmacovigilance system in place, and the quality system that supports it.

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

GVP and VGVP Auditing & Inspections are therefore an essential legal requirement to maintain and demonstrate a fully documented and organised proof of compliance, and of course to be inspection ready if required. Their planning, and especially across a portfolio of products, is the basis of Audit Program Management.

Click here for more information from the EMA on GVP auditing.

Click here for more information from the EMA on VGVP auditing.

Audit objective & criteria.

The objective of conducting a GVP or VGVP audit is to ensure that both the pharmacovigilance system and the supporting pharmacovigilance quality system comply with regulatory requirements. The audit criteria serve as benchmarks for the expected standards of performance and control within these systems.

GVP and VGVP audits should be a methodical, independent, and well-documented process involving the systematic collection of necessary evidence, such as relevant documentation and statements. This evidence is then objectively evaluated to determine the extent to which the audit criteria are met.

It is essential for pharmacovigilance audits to adopt a risk-based approach, emphasising the identification of areas with the highest risk to the pharmacovigilance system, quality system for pharmacovigilance, and, most importantly, public health.

 

Risk is assessed at the following audit planning levels:

Strategic Level Audit Planning: This phase involves the development of a long-term audit strategy requiring endorsement from senior management.

Tactical Level Audit Planning: The tactical level focuses on creating an audit program that outlines audit objectives and the scope of audits within that program.

Operational Level Audit Planning: At the operational level, the focus is on crafting an audit plan for individual audit engagements. This involves prioritizing audit tasks based on a risk-based methodology, reporting audit findings in alignment with their relative risk levels and providing ranked or graded audit recommendations.

Common areas within a GVP/VGVP safety audit.

Planned audits will vary in scope but a GVP/VGVP audit will typically review the following areas:

  • Pharmacovigilance System Master File (PSMF).
  • Marketing Authorisations and Registrations.
  • Standard Operating Procedures (SOPs) review.
  • Risk Management Plan (RMP).
  • Risk Minimisation Measures (RMMs).
  • Signal Management.
  • Safety Database validation and review.
  • Adverse Event Reports (AERs) and Individual Case Safety Reports (ICSRs) and timelines.
  • Internal and external reporting timelines.
  • Report quality.
  • Authority communications.
  • IT systems and backups.
  • Business Continuity Plan.
  • Affiliates, Vendors, and safety and data agreements with them.
  • Previous audit findings and plans.
  • Organisational change.

Why choose Aegisana for your GVP and VGVP Auditing?

Experience & expertise.

Aegisana’s compliance team has a comprehensive understanding of pharmacovigilance processes, including the associated quality system requirements.

Our GVP/VGVP Auditing & Inspections services cover the entire spectrum of compliance and inspection readiness for Post-marketing and Veterinary Pharmacovigilance across your product portfolio.

Audits are conducted with both internal and external auditors, all of whom are experienced with the requirements for GVP/VGVP and the latest regional legislative changes.

Communication, reliability, trust.

Our goal is to provide you with peace of mind and confidence by thoroughly reviewing and assessing all your pharmacovigilance compliance processes, with all levels of risk clearly identified and communicated in our audit findings.

Through effective communication, reliability, and trust, we aspire to establish a successful and robust strategic compliance and auditing partnership throughout the entire life cycle of your human and animal products.

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