Preparing for WHO PQ Inspections: A Practical Audit Checklist for East African Manufacturers
WHO Prequalification audits remain the gold standard for accessing donor-funded tenders across EAC and SADC markets. Drawing from recent inspection experiences across Kenya, Tanzania and Uganda, our team breaks down the 14 most common deficiencies and how to address them before the inspector arrives.
By the ECP Regulatory TeamNairobi, Kenya
WHO Prequalification (PQ) inspection readiness is less about a heroic push in the final weeks and more about whether your quality system works on an ordinary Tuesday. Inspectors look for evidence that procedures are followed, that records tell a consistent story, and that management actually owns quality.
How to use this checklist
Work through the areas below as a self-inspection, assigning an owner and a due date to every gap. Evidence matters more than intention: for each item, ask what record would convince an inspector who has never visited your site.
The patterns that repeat
Across audits, the same themes recur: procedures that describe an ideal rather than the actual practice, investigations that stop at “operator error”, and records completed after the fact. None of these are fixed by writing more SOPs. They are fixed by simplifying procedures to what people really do, then training and checking against that.
In the last 90 days
Run a full mock inspection with someone who has not seen the site before.
Close or formally justify every open CAPA, and be ready to show effectiveness checks.
Walk the inspector’s likely route yourself: receiving, warehouse, production, QC, then documentation.
Brief the whole team: who answers questions, how to say “I don’t know, let me find the record”, and where records live.
ECP supports manufacturers through gap assessment, remediation planning and mock inspections. Get in touch if you would like us to review your readiness before the audit date is confirmed.
