Evidence, not assurance
Compliance must be demonstrated through evidence, not verbal assurance.
Playbook
Preparing for regulatory and partner audits in Kenya
A structured approach to inspection readiness for pharmaceutical manufacturers, distributors, and MAHs operating in Kenya — documentation requirements, facility expectations, team preparation, and the gaps identified most often during PPB and WHO inspections.
01 — Core principles
Four things every inspector assumes you already know
Systems, not individuals
Inspectors evaluate systems, not individuals.
Complete and controlled
Documentation must be complete, current, and controlled.
Discipline, not preparation
Facilities must reflect consistent operational discipline, not temporary preparation.
02 — Documentation readiness
Complete, approved, and accessible
Ensure every one of the following is in place before an inspection date is confirmed — not after.
A Quality system
- Quality Manual
- SOPs — GSDP, GMP, Deviation, Change Control, CAPA, Recall, Complaints, QRM
- Training records
B Operations
- Batch records / distribution logs
- Supplier qualification files
- Cleaning and sanitization logs
- Temperature mapping reports
- Calibration & maintenance records
C Regulatory
- Product registration certificates
- Variations & renewal history
- Recall & mock recall reports
03 — Facility readiness
What inspectors expect to see on the floor
The facility either reflects the documentation or contradicts it. There is no third outcome.
Storage areas
Clean, organized, and clearly labeled.
Restricted zones
Controlled access, with entry logged and reviewable.
Calibrated equipment
With visible status labels showing current calibration state.
Temperature monitoring
Continuous systems with alarms, and excursions investigated.
Pest control records
Current contracts, service reports, and trend review.
Fire safety
Equipment in place with evacuation plans displayed.
Segregation
Quarantined, rejected, expired and returned goods physically separated.
04 — Team preparation
Train staff to
- Answer questions clearly and factually
- Demonstrate processes using SOPs
- Retrieve documents quickly
- Escalate issues appropriately
- Avoid speculation or assumptions
05 — Common findings
What goes wrong in Kenya
- Missing or obsolete SOPs
- Poor documentation practices
- Incomplete supplier qualification
- Temperature excursions not investigated
- Uncontrolled access to storage areas
- Inadequate recall readiness
06 — Final readiness review
Run the mock audit two to four weeks out
Conduct a mock audit two to four weeks before inspection. Document all findings and close gaps with CAPAs. Any closer and there is no time to correct what you find; any earlier and the evidence will have drifted by the time inspectors arrive.