Get a GMP inspection and certificate for a medicine factory (PPB)
Pharmacy and Poisons Board · sources read 3 Oct 2026
Apply for the GMP inspection on PPB's PRIMS portal and send your latest site master file. After the inspection, send your corrective action plan (CAPA) within 30 working days; once PPB accepts it, you get a GMP certificate with the inspection report.
- Fee
- We couldn't confirm a fee from the official page. Check it there before you pay.
- Where
- Online on PPB's PRIMS portal (prims.pharmacyboardkenya.org)
What you need
- Your latest site master file, in the WHO format
- After the inspection: your CAPA (corrective and preventive actions, with dates)
Steps
- Apply for the inspection on PRIMS (prims.pharmacyboardkenya.org).
- PPB draws up inspection schedules every six months and gives you a tentative date and team.
- Inspectors visit, interview staff and check documents. At the closing meeting they explain any deficiencies and the deadlines to fix them.
- Submit your CAPA on the GMP PRIMS system within 30 working days of getting the preliminary report (15 working days in a second round).
- If PPB accepts your CAPA, you are issued a GMP certificate with the inspection report.
Watch out
- Missing the CAPA deadlines, or sending a weak CAPA, can mean having to apply for GMP certification all over again.
- PPB only certifies blocks that make human medicines. Veterinary blocks are not covered and must be separate.
- Factories abroad may avoid a site visit: PPB can rely on GMP decisions or inspection reports from recognised regulators.
Who can apply
- Holders of a manufacturing licence in Kenya
- Factories abroad that hold, or want, a Kenyan marketing authorisation
Official sources (3)
- Kenya Good Manufacturing Practices Guideline (Rev. 03, August 2026) web.pharmacyboardkenya.org · read 3 Oct 2026
- Good Manufacturing Practices Division web.pharmacyboardkenya.org · read 3 Oct 2026
- PPB Online Services Portal (PRIMS) prims.pharmacyboardkenya.org · read 3 Oct 2026