5 tips for successful PV audits

How to master GVP audits with structure, expertise, and foresight

Pharmacovigilance audits - or GVP audits for short - are a central component of a functioning PV system. They not only help to meet regulatory requirements, but also strengthen trust and cooperation with internal and external partners.

But what makes an audit successful? We summarize the 5 most important tips for you.

1. An audit is more than just a date in the calendar

An audit does not begin on the day of the meeting - but weeks or months beforehand. Successful audits are based on a three-stage planning process:

• Strategic planning (2-5 years): How will partner and affiliate risk be captured and how will it be assessed?
• Tactical planning (annually): Who is at high risk? Which partners and affiliates will be audited this year?
• Operational Planning: Who audits whom, when and with what focus?

Tip: Anchor the planning logic in your SOP and document the risk assessment in a comprehensible manner.

2. The right preparation saves nerves - and time

A good audit report starts with good preparation. This means requesting the right documents in good time and evaluating them in a structured manner.

• PSMF and associated annexes
• QM manual (table of contents is often sufficient)
• Contracts
• Organizational charts of the audited company
• Qualifications of the QPPV or local contact person

Tip: Use checklists and templates for preparation and implementation. These save time and increase the quality of your audits.

3. Objectivity is mandatory - and sometimes a challenge

A frequent stumbling block in small companies: The most competent PV experts (QPPVs) are not allowed to audit for their own company because they are responsible for the PV processes. GVP Module IV requires independence and objectivity.

Tip: If no suitable auditors are available internally, bring in external service providers - especially for sensitive or complex PV issues. Find out more here: PV services.

4. Turn the audit meeting into a joint working phase

The actual audit is more than just a control event. It thrives on dialog, on understanding the processes and - very importantly - on mutual respect.
A typical procedure:

• Opening meeting
• Company presentation
• Questions & evidence check (e. g. SOPs, training documents)
• Inspection (on site)
• Final meeting with initial results

Tip: Keep the meeting structured but open. Find the balance between control and cooperation.

5. Categorise findings clearly - and act consistently

Not every finding is equally critical. The GVP distinguishes between:

• Critical (serious, system-endangering)
• Major (significant weaknesses)
• Minor (minor deviations)

Critical findings should be communicated immediately and included in the PSMF body (Pharmacovigilance System Master File). Remediation must be prioritized. If necessary, even a business relationship must be called into question.

Tip: Ask for a clear CAPA plan (Corrective and Preventive Action Plan) - and only officially conclude the audit once the measures have been defined.

Conclusion

A good PV audit is no coincidence. With structured planning, professionally qualified and empathetic auditors and a clear focus on communication and quality, audits can not only be successful - they can also improve processes, build trust, and strengthen cooperation.
Use internal training courses, external workshops, and practical tools such as checklists - then your next audit will not be a stress factor, but a real opportunity. So, stay curious and ask questions.
We are happy to support you in all areas of pharmacovigilance: https://www.hwi-group.de/en/services/pharmacovigilance/pv-services

Any questions?

Many more tips and guidelines - including typical findings from inspections by authorities - can be found on the BfArM website or in DIN EN ISO 19011.