Perform 21 CFR Part 110 – GMP Inspection using eAuditor
21 CFR Part 110 – GMP refers to the section of the Code of Federal Regulations (Title 21, Part 110) established by the U.S. Food and Drug Administration (FDA) that outlines the Current Good Manufacturing Practices (GMP) for manufacturing, packing, or holding human food. It was a foundational regulation intended to ensure food safety and sanitary processing conditions.
Performing 21 CFR Part 110 – GMP Inspection using eAuditor ensures a systematic evaluation of food manufacturing practices, sanitation standards, and facility conditions to maintain product safety, hygiene, and regulatory compliance as outlined in legacy FDA Good Manufacturing Practices.
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Purpose of the Inspection
The goal of conducting a 21 CFR Part 110 – GMP Inspection using eAuditor is to verify that food processing, packaging, and storage operations follow hygienic practices and maintain sanitary conditions, minimizing the risk of contamination and ensuring product safety. Though superseded by 21 CFR Part 117, many facilities still use Part 110 principles for internal audits or training.
This inspection aims to:
- Identify potential sources of contamination or cross-contamination
- Confirm the proper use and maintenance of equipment and utensils
- Ensure personnel follow hygienic practices
- Validate sanitation processes and facility upkeep
- Prepare for FDA inspections or third-party audits using traditional GMP benchmarks
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Setting Up the eAuditor Template
2.1 Key Areas to Include from 21 CFR Part 110
To align your digital checklist with the core elements of 21 CFR Part 110, include the following sections:
- Personnel Practices
- Hand hygiene and glove usage
- Illness and injury protocols
- Clean protective clothing and hair restraints
- Training in sanitation and food handling
- Plant and Grounds
- Exterior conditions are free of debris and pests
- Well-maintained drainage to avoid standing water
- Controlled access to food processing areas
- Sanitary Operations
- Cleaning and sanitization schedules
- Proper use and labeling of cleaning chemicals
- Pest control measures are in place and documented
- Facilities and Controls
- Functioning handwashing stations and restrooms
- Adequate lighting and ventilation
- Proper plumbing, wastewater, and waste management
- Equipment and Utensils
- Made of non-toxic, corrosion-resistant materials
- Designed for easy cleaning and proper drainage
- Cleaned and sanitized at appropriate intervals
- Processes and Controls
- Time and temperature control for food safety
- Prevention of allergen cross-contact
- Measures to avoid contamination from employees or the environment
- Storage and Distribution
- Clean, dry storage areas with proper labeling
- FIFO (First In, First Out) applied to raw materials and finished goods
- Secure transportation practices that maintain integrity
- Defect Action Levels
- Monitoring for unavoidable defects (e.g., insect fragments)
- Corrective actions are taken if limits are exceeded
2.2 Checklist Features in eAuditor
Build the template in eAuditor with:
- Yes/No/NA response options for quick checks
- Photo fields for evidence capture
- Notes/comments section for observations
- Auto-score fields to rate compliance
- Signature capture for inspector verification
- Conditional logic to hide/show relevant sections based on prior answers
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Conducting the Inspection
3.1 Preparation
- Notify teams of the inspection and its scope
- Ensure inspectors have mobile devices with the updated checklist
- Review previous audit results to focus on high-risk or repeat areas
3.2 Execution of the Inspection
Walk through the facility in a logical sequence, assessing:
- Staff behavior and hygiene during active operations
- Cleanliness of equipment, walls, floors, and ceilings
- Placement and condition of pest control devices
- Storage areas for raw materials, packaging, and finished products
- Maintenance and calibration of thermometers, refrigerators, and freezers
- Sanitation logs and chemical storage practices
Inspectors should:
- Mark the compliance status for each item
- Document violations or areas needing attention with photos
- Interview staff when clarification is needed
- Check records for training, cleaning, pest control, and maintenance
3.3 Real-Time Documentation
- All inspection data is instantly saved and backed up
- Notes and visual documentation strengthen the integrity of findings
- Time stamps and GPS data validate inspection activity
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Reporting and Follow-Up
4.1 Generate and Share Reports
Once the inspection is complete:
- eAuditor automatically compiles a full audit report
- Includes a compliance score summary, photos, notes, and signatures
- Reports can be exported as PDF, Word, or Excel and emailed to stakeholders
4.2 Assigning and Tracking Corrective Actions
For each non-compliant item:
- Assign a corrective task to the relevant team or individual
- Set deadlines, attach instructions, and monitor through the eAuditor’s Actions dashboard
- Track completion status and document follow-up actions with photos or notes
4.3 Analysis and Continuous Improvement
- Use eAuditor’s analytics dashboard to:
- Track trends in non-compliance
- Identify recurring issues or high-risk areas
- Support planning of staff training or facility upgrades
- Maintain historical records for audit readiness and regulatory reference
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Best Practices for Ongoing Compliance
- Transition to 21 CFR Part 117 checklists while using Part 110 as a foundation
- Schedule regular self-inspections and unannounced checks
- Cross-train staff on GMP procedures and personal hygiene standards
- Conduct mock FDA audits using eAuditor to simulate real-world inspection scenarios
- Integrate SOP documentation, cleaning logs, and temperature records into eAuditor for centralized visibility
Summary
Performing 21 CFR Part 110 – GMP Inspection using eAuditor enhances food safety compliance by digitizing the evaluation of personnel hygiene, facility conditions, equipment cleanliness, and process controls. Though Part 110 has been replaced by modern FSMA regulations, it remains a valuable framework for foundational GMP assessments. eAuditor’s customizable checklists, real-time documentation, and corrective action tracking make it an ideal tool to ensure your facility consistently meets essential hygiene and operational standards while preparing for the transition to more advanced regulatory expectations.