21 CFR Part 110 – GMP Checklist
21 CFR Part 110 -GMP is the section of the U.S. Code of Federal Regulations that outlined the Good Manufacturing Practices (GMP) for food products. This regulation is designed to ensure that food was produced under conditions that minimized the risk of contamination and ensured safety and quality.
Personnel
- Health and Hygiene:
- Employees report illness and infections.
- Proper hair restraints are used.
- Does Employee wear clean and appropriate clothing?
- Are Employees following good hygiene practices, including proper handwashing?
Plant and Grounds
- Grounds:
- Grounds are maintained to prevent contamination.
- Waste and trash are managed properly.
- Building:
- Facilities are of suitable size, construction, and design.
- Adequate lighting in all areas.
- Adequate ventilation to prevent contamination.
- Floors, walls, and ceilings are clean and in good repair.
- Sufficient space for equipment and storage.
Sanitary Operations
- General Maintenance:
- Cleanliness of food contact surfaces.
- Regular cleaning schedules are followed.
- Detergents and sanitizers are used correctly.
- Pest Control:
- Effective pest control measures are in place.
- Regular inspections for pests.
- Waste Disposal:
- Waste is removed regularly and stored properly.
- Adequate drainage and plumbing.
Sanitary Facilities and Controls
- Water Supply:
- Safe and sanitary water supply.
- Water is tested regularly for safety.
- Plumbing:
- Plumbing systems are in good condition.
- Adequate drainage to prevent contamination.
- Toilet Facilities:
- Sufficient number of toilets.
- Toilets are clean and sanitary.
- Handwashing facilities are available and functional.
- Handwashing Facilities:
- Accessible and adequately stocked with soap and towels.
- Hot and cold running water available.
Equipment and Utensils
- Design and Maintenance:
- Equipment is designed for easy cleaning.
- Regular maintenance of equipment.
- Utensils are clean and sanitary.
- Cleaning and Sanitizing:
- Equipment and utensils are cleaned and sanitized regularly.
- Cleaning logs are maintained.
- Food Contact Surfaces:
- Surfaces are smooth, non-toxic, and easy to clean.
Processes and Controls
- Raw Materials:
- Raw materials are inspected upon receipt.
- Are Raw materials stored to prevent contamination.
- Manufacturing Operations:
- Adequate controls to prevent contamination.
- Allergen controls are in place.
- Ingredients are measured accurately.
- Temperature Controls:
- Appropriate temperatures are maintained during processing and storage.
- Temperature logs are maintained.
- Packaging and Labeling:
- Packaging materials are safe and sanitary.
- Labels are accurate and compliant with regulations.
Warehousing and Distribution
- Storage:
- Finished products are stored to prevent contamination.
- Storage areas are clean and organized.
- Distribution:
- Finished products are transported under conditions to prevent contamination.
- Records of distribution are maintained.
Record-Keeping
- Documentation:
- All GMP-related activities are documented.
- Records are kept for the required period.
- Documentation is accurate and complete.
Compliance
- Regulatory Compliance:
- Compliance with all applicable FDA regulations.
- Regular internal audits to ensure compliance.
- Corrective actions are documented and implemented.
Additional Considerations
- Training:
- Employees are trained in GMP practices.
- Training records are maintained.
- Recall Procedures:
- Recall procedures are in place.
- Regular mock recalls are conducted.
- Allergen Management:
- Allergen control program is in place.
- Cross-contact prevention measures are followed.
eAuditor Audits & Inspections Features for 21 CFR Part 110 Checklist Inspection
- User Authentication:
- Secure login for inspectors and staff.
- Customizable 21 CFR Part 110 Checklist:
- Allow users to customize 21 CFR Part 110 Checklist and add specific items.
- Photo Attachments:
- Option to attach photos for documentation.
- Real-Time Sync:
- Sync data in real-time with a central database.
- Offline Mode:
- Functionality to use the app without internet access and sync later.
- Automated Reports:
- Generate and email reports automatically.
- Notifications:
- Alerts for upcoming inspections, maintenance schedules, etc.
- Signature Capture:
- Allow inspectors to sign off on inspections digitally.
- Comment Section:
- Space for additional notes and observations.
- Scoring System:
- Automatically calculate compliance scores.
- Analytics Dashboard:
- Visualize inspection data over time.
21 CFR Part 110 Checklist Structure
Personnel
- Health and Hygiene:
- Employees report illness and infections.
- Employees wear clean and appropriate clothing.
- Do Employees follow good hygiene practices, including proper handwashing?
- Proper hair restraints are used.
- Photo Attachment
- Comments
Plant and Grounds
- Grounds:
- Grounds are maintained to prevent contamination.
- Waste and trash are managed properly.
- Photo Attachment
- Comments
- Building:
- Facilities are of suitable size, construction, and design.
- Adequate lighting in all areas.
- Adequate ventilation to prevent contamination.
- Floors, walls, and ceilings are clean and in good repair.
- Sufficient space for equipment and storage.
- Photo Attachment
- Comments
Sanitary Operations
- General Maintenance:
- Cleanliness of food contact surfaces.
- Regular cleaning schedules are followed.
- Detergents and sanitizers are used correctly.
- Photo Attachment
- Comments
- Pest Control:
- Effective pest control measures are in place.
- Regular inspections for pests.
- Photo Attachment
- Comments
- Waste Disposal:
- Waste is removed regularly and stored properly.
- Adequate drainage and plumbing.
- Photo Attachment
- Comments
Sanitary Facilities and Controls
- Water Supply:
- Safe and sanitary water supply.
- Water is tested regularly for safety.
- Photo Attachment
- Comments
- Plumbing:
- Plumbing systems are in good condition.
- Adequate drainage to prevent contamination.
- Photo Attachment
- Comments
- Toilet Facilities:
- Sufficient number of toilets.
- Toilets are clean and sanitary.
- Handwashing facilities are available and functional.
- Photo Attachment
- Comments
- Handwashing Facilities:
- Accessible and adequately stocked with soap and towels.
- Hot and cold running water available.
- Photo Attachment
- Comments
Equipment and Utensils
- Design and Maintenance:
- Equipment is designed for easy cleaning.
- Regular maintenance of equipment.
- Utensils are clean and sanitary.
- Photo Attachment
- Comments
- Cleaning and Sanitizing:
- Equipment and utensils are cleaned and sanitized regularly.
- Cleaning logs are maintained.
- Photo Attachment
- Comments
- Food Contact Surfaces:
- Surfaces are smooth, non-toxic, and easy to clean.
- Photo Attachment
- Comments
Processes and Controls
- Raw Materials:
- Raw materials are inspected upon receipt.
- Are Raw materials stored to prevent contamination?
- Photo Attachment
- Comments
- Manufacturing Operations:
- Adequate controls to prevent contamination.
- Allergen controls are in place.
- Ingredients are measured accurately.
- Photo Attachment
- Comments
- Temperature Controls:
- Appropriate temperatures are maintained during processing and storage.
- Temperature logs are maintained.
- Photo Attachment
- Comments
- Packaging and Labeling:
- Packaging materials are safe and sanitary.
- Labels are accurate and compliant with regulations.
- Photo Attachment
- Comments
Warehousing and Distribution
- Storage:
- Finished products are stored to prevent contamination.
- Storage areas are clean and organized.
- Photo Attachment
- Comments
- Distribution:
- Finished products are transported under conditions to prevent contamination.
- Records of distribution are maintained.
- Photo Attachment
- Comments
Record-Keeping
- Documentation:
- All GMP-related activities are documented.
- Records are kept for the required period.
- Documentation is accurate and complete.
- Photo Attachment
- Comments
Compliance
- Regulatory Compliance:
- Compliance with all applicable FDA regulations.
- Regular internal audits to ensure compliance.
- Corrective actions are documented and implemented.
- Photo Attachment
- Comments
Additional Considerations
- Training:
- Employees are trained in GMP practices.
- Training records are maintained.
- Photo Attachment
- Comments
- Recall Procedures:
- Recall procedures are in place.
- Regular mock recalls are conducted.
- Photo Attachment
- Comments
- Allergen Management:
- Allergen control program is in place.
- Cross-contact prevention measures are followed.
- Photo Attachment
- Comments
Additional eAuditor Audits & Inspection Functionalities
- Signature Capture: Allow inspectors to sign off on inspections digitally.
- Comment Section: Space for additional notes and observations.
- Scoring System: Automatically calculate compliance scores.
- Analytics Dashboard: Visualize inspection data over time.