Audit Planning and Preparation
- Review prior GMP audit reports and corrective actions
- Determine audit scope and focus areas
- Develop audit checklist based on regulatory standards
- Schedule interviews and facility walkthroughs
- Communicate audit plans to facility management
Personnel and Training Verification
- Assess hygiene practices and PPE compliance
- Verify employee GMP training records and frequency
- Review competency assessment processes
- Check health monitoring and reporting systems
Facility and Equipment Inspection
- Inspect facility layout for contamination control
- Evaluate maintenance and sanitation of production areas
- Check equipment validation and calibration records
- Assess environmental monitoring systems
Documentation and Record Review
- Examine batch production and control records
- Verify accuracy and completeness of documentation
- Review SOPs and operational documentation
- Check electronic records and data integrity
Reporting and Follow-up
- Conduct closing meeting with audit findings
- Document non-conformances and corrective actions
- Distribute audit report to relevant stakeholders
- Establish timelines for implementing corrective actions
- Schedule follow-up audit to verify corrections