21 CFR Part 110 GMP Checklist eAuditor Audits and inspection

https://eauditor.app/2024/08/08/21-cfr-part-110-gmp-checklist/

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.

21 CFR Part 110

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.

1. 21 CFR Part 110 GMP Checklist
21 CFR Part 110 is the section of the U.S. Code of Federal Regulations that outlines Good
Manufacturing Practices (GMP) for food products. This regulation ensures food is produced
under conditions that minimize contamination risk and guarantee safety and quality.

2. Personnel Standards
Health & Hygiene
Employees must report illness and infections,
maintaining strict hygiene protocols.
Proper Attire
Clean, appropriate clothing and proper hair
restraints are required at all times.
Handwashing Practices
Employees follow rigorous handwashing and
and personal hygiene practices.

3. Plant and Grounds Requirements
Grounds Maintenance
• Grounds maintained to prevent contamination
• Proper waste and trash management systems
• Regular inspection schedules
Building Standards
• Suitable size, construction, and design
• Adequate lighting and ventilation
• Clean floors, walls, and ceilings in good repair
• Sufficient space for equipment and storage

4. Sanitary Operations & Controls
1
General Maintenance
Food contact surfaces must be clean
clean with regular cleaning schedules
schedules followed. Detergents and
and sanitizers are used correctly and
and documented.
2
Pest Control
Effective pest control measures are in
place with regular inspections
conducted to identify and eliminate
potential infestations.
3
Waste Disposal
Waste is removed regularly and stored properly. Adequate drainage and plumbing
plumbing systems prevent contamination risks.

5. Sanitary Facilities Standards
Water Supply
Safe and sanitary water supply with regular testing for safety
compliance. Water quality is monitored and documented continuously.
continuously.
Plumbing Systems
Plumbing systems maintained in good condition with adequate
drainage to prevent contamination throughout the facility.
Toilet Facilities
Sufficient number of clean, sanitary toilets with functional
handwashing facilities available to all personnel.
Handwashing Stations
Accessible stations adequately stocked with soap and towels, featuring
featuring hot and cold running water for proper hygiene.

6. Equipment, Processes & Controls
Equipment Standards
•Designed for easy cleaning
•Regular maintenance schedules
•Clean and sanitary utensils
•Smooth, non-toxic food contact surfaces
•Cleaning logs maintained
Manufacturing Operations
•Raw materials inspected upon receipt
•Adequate contamination controls
•Allergen controls in place
•Accurate ingredient measurement
•Temperature logs maintained
Packaging & Labeling
•Safe and sanitary packaging materials
•Accurate, compliant labels
•Proper storage conditions
•Contamination prevention during transport

7. eAuditor Digital Inspection Features
Customizable Checklists
Customize 21 CFR Part 110 checklists with specific
items, photo attachments, and real-time sync
capabilities.
Digital Documentation
Signature capture, automated reports, and offline
mode functionality for seamless inspections
anywhere.
Analytics & Reporting
Automated scoring system, analytics dashboard,
and notifications for upcoming inspections and
maintenance schedules.

8. Compliance & Documentation
Excellence
Record-Keeping
All GMP-related activities documented
documented with records kept for
required periods. Documentation must
must be accurate and complete.
Regulatory Compliance
Compliance with all applicable FDA
regulations through regular internal
internal audits. Corrective actions
documented and implemented.
Training & Procedures
Employees trained in GMP practices with maintained training records. Recall procedures
procedures and allergen management programs in place.
eAuditor Audits & Inspections provides comprehensive digital tools to streamline 21 CFR Part
110 compliance, ensuring food safety and quality through efficient, accurate documentation
and real-time monitoring.