Pharmacovigilance
GVP audits

Safety with System – GVP Audit Services

A functioning pharmacovigilance system thrives on transparency, quality, and continuous improvement. GVP audits (Good Pharmacovigilance Practice audits) are a central instrument in achieving this.

We take responsibility.

GVP audits are not only necessary to meet regulatory requirements but also to strengthen the quality and performance of your PV system. This builds trust and promotes collaboration with partners and authorities.

As an interdisciplinary team with many years of experience in drug safety, we advise you on all aspects of pharmacovigilance and support you in conducting GVP audits – fully aligned with current GVP guidelines. This includes, among other things, the planning, conduct, and follow-up of your GVP audits.

We guide you through the entire audit process – from strategic planning to final CAPA implementation.

Our services around GVP audits

GVP audit consulting

The EU QPPV (Qualified Person for Pharmacovigilance) is responsible for ensuring that all required pharmacovigilance activities are performed in accordance with GVP. This includes the development of initial audit processes, risk-based assessment of potential partner companies using PV questionnaires, as well as the creation of a strategic audit plan. Additionally, Safety Data Exchange Agreements (SDEAs) are concluded with local partners, if not already in place. We support you with the following:

Strategic audit planning, i.e., risk-based audit programs spanning multiple years
Tactical & operational implementation, i.e., selection of relevant partners, scheduling, and definition of focus
Development of a GVP-compliant audit process, including documentation and clear role allocation
PV questionnaires & partner assessments

Conducting GVP audits

Audits are generally carried out by two auditors. The subjects of the audit are the quality management and pharmacovigilance systems of the partner, co-distributor or supplier.
We offer:

Provision of the required number of auditors by HWI
Coordination of audit scheduling
Objective, structured audit execution by our EU QPPV
Document review, including analysis of PSMF (Pharmacovigilance System Master File), contracts, SOPs, training documents, and more
Audit interviews conducted as structured dialogues, including evidence review
Categorization of findings and structured documentation according to GVP criteria (Critical, Major, Minor)
Preparation of the audit report

Post-audit follow-up

Thorough post-audit follow-up is essential for the continuous improvement of the pharmacovigilance system. We support you not only during the audit but also in the professional post-processing phase. We assist with the structured analysis of audit results, audit report creation, development of effective CAPA plans, and sustainable optimization of your PV system.

We offer:

CAPA management: Development and follow-up of Corrective and Preventive Action Plans
Implementation & monitoring: Assignment of responsibilities, setting deadlines, continuous progress tracking, documentation for internal records and external inspections
Effectiveness checks
Evaluation of CAPA measures and adjustment of processes, if needed
System optimization, i.e., integrating audit findings into SOPs, training materials, and processes