PPB Pharmacovigilance Audit Checklist for Kenyan MAHs

PPB inspections — routine and unannounced — can be conducted at the MAH's or its outsourced provider's offices, and your QPPV is expected to represent the company throughout. Preparation isn't something to start once an inspection is scheduled.

What inspectors typically review

• Whether your QPPV is properly nominated, contactable, and aware of current product-level obligations
• Whether your PSMF accurately reflects how your PV system actually operates day to day
• PSUR and ADR submission history against required timelines
• Evidence of ongoing literature surveillance and signal detection, not just SOPs describing them
• Staff training records for anyone involved in PV workflows

Common gaps that surface during audits The most frequent finding isn't a missing document — it's a mismatch between what the PSMF describes and what the team's actual day-to-day process looks like, or a paper trail with gaps around specific PSUR cycles.

A practical pre-audit checklist

• Confirm QPPV contact details are current with PPB
• Reconcile your PSUR submission log against actual due dates for every active product
• Spot-check that recent ADRs were logged and reported within their 15-day/90-day windows
• Confirm literature surveillance documentation exists for the current reporting period, including negative findings
• Review staff training records for currency

How PvSentinel keeps an always-current audit trail across your portfolio

FAQ

How much notice does PPB give before an inspection? Inspections can be unannounced, which is why ongoing documentation — not last-minute preparation — is the more reliable strategy. Who is held responsible for gaps found during an audit? Sanctions can apply to the MAH, LTR, manufacturer, or QPPV depending on where the gap originated.