PV Audits & Inspections
Audits of your pharmacovigilance system and your partners — plus preparation for and support during regulatory inspections.
What are PV audits and inspections?
A pharmacovigilance audit checks whether the system as described matches the system as practised — in-house or at partners and service providers. An inspection is the authority’s examination of the same system. Both follow the same logic: demonstrating that the processes exist, are applied and are documented.
Why does it matter?
If you only find out during an inspection where your system falls apart, you are negotiating from the weakest position. An internal audit finds the same points beforehand — with time to fix them. Partners are particularly underestimated: outsourced activities remain your responsibility, and a service provider that has never been audited is a blind spot in your own system.
Who needs it?
Marketing authorisation holders whose pharmacovigilance system is subject to audit, companies with outsourced activities, and all those for whom an inspection has been announced or is due.
What do the regulations require?
- GVP Module IV — risk-based audits of the pharmacovigilance system
- GVP Module III — pharmacovigilance inspections
- Audit obligation also for outsourced activities and contracted third parties
- Follow-up of findings through a documented CAPA process
How VigiPRO supports you
- Audits of entire pharmacovigilance systems or individual parts thereof
- Audits of partners and service providers nationally and internationally
- Preparation for inspections, including a review of the documentation
- Support during the inspection
- Follow-up: assessing findings, planning CAPA and tracking it through to closure
Why VigiPRO
VigiPRO has worked as lead pharmacovigilance auditor and knows both sides of the table. Audits are conducted against what is actually inspected — not against a generic checklist.
Frequently asked questions
How often does the pharmacovigilance system have to be audited?
On a risk basis. The frequency follows from a justified audit plan that takes criticality, changes and previous findings into account. The plan itself is subject to inspection.
Do we have to audit our service providers?
Outsourced activities remain the responsibility of the marketing authorisation holder. They must therefore be covered by the risk-based audit programme and governed by the pharmacovigilance contract.
How long does it take to prepare for an inspection?
That depends on the state of the documentation. If the PSMF is up to date and training and CAPA records are complete, it is a matter of weeks. If they are not, the preparation becomes the actual project — which is why a preliminary check makes sense before an inspection is announced.
Tell us what it is about — you get a quote, not a brochure.
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