1. Personnel Hygiene & Practices
- Verify proper use of gloves, hairnets, and uniforms
- Check employee handwashing procedures and signage
- Inspect training logs for hygiene and safety protocols
- Confirm no eating or personal items in production areas
2. Facility Sanitation
- Review sanitation schedules and cleaning records
- Check effectiveness of cleaning procedures and tools
- Ensure waste disposal bins are covered and labeled
- Inspect drains, walls, ceilings, and vents for cleanliness
3. Pest Control Measures
- Validate pest control logs and third-party service contracts
- Inspect traps, bait stations, and entry point seals
- Document sightings or pest incidents with corrective actions
- Ensure perimeter and storage areas are free of infestations
4. GMP Documentation & Records
- Review SOPs, GMP policies, and flow diagrams
- Check calibration records for equipment and tools
- Audit training documentation and competency assessments
- Verify batch records, traceability forms, and non-conformance logs
5. Regulatory & Audit Readiness
- Review previous audit findings and closure reports
- Ensure signage for allergen control, hygiene, and emergency exits
- Conduct mock inspections simulating audit scenarios
- Maintain updated contact list of quality assurance team and inspectors