Pre-Audit Preparation
- Review previous GMP audit reports and corrective actions
- Analyze recent quality data and trends
- Prepare a detailed audit checklist tailored to the facility
- Identify and prioritize high-risk areas for inspection
- Schedule interviews with key quality personnel
Documentation Review
- Verify the control and currency of SOPs
- Review completeness and accuracy of batch records
- Inspect deviation reports and corrective actions
- Examine validation records for critical processes
- Assess training documentation and compliance
Facility and Equipment Inspection
- Observe employee hygiene and gowning practices
- Check cleanliness and sanitation of production areas
- Verify equipment qualification and maintenance status
- Inspect storage and handling of raw materials
- Ensure environmental control systems are effective
Production Process Observation
- Observe critical manufacturing operations closely
- Confirm adherence to documented procedures
- Monitor in-process controls and testing procedures
- Evaluate the effectiveness of cleaning procedures
- Assess employee proficiency and procedure compliance