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Sanitary Facility Design & GMP Zoning Checklist
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Assess plant grounds, construction, and hygienic zoning to prevent contamination and support sanitary operations under current Good Manufacturing Practices.
21 CFR 117FDA Food Code
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Grounds
- Are the grounds kept free of litter, waste, and debris that could constitute an attractant or harborage for pests? *
- Are roads, yards, and parking areas maintained to prevent contamination from dust and standing water? *
- Is drainage adequate to prevent contamination and pooling that could harbor pests? *
Building Construction
- Is the plant suitable in size, construction, and design to facilitate maintenance and sanitary operations? *
- Is there adequate space for equipment placement and storage of materials? *
- Are floors, walls, and ceilings constructed of cleanable materials and kept in good repair? *
- Are aisles and working spaces kept unobstructed and of adequate width?
Hygienic Zoning
- Are the facility zones classified (e.g., raw, transitional, ready-to-eat / high-care) with defined boundaries? *
- Do process flows and personnel movement prevent cross-traffic from lower-hygiene to higher-hygiene zones? *
- Are separate or controlled entrances, footwear controls, and hand-hygiene stations provided at zone transitions? *
- Is air pressure or airflow managed to protect higher-hygiene zones where required?
Utilities and Services
- Is lighting adequate and are bulbs over exposed product shatter-protected? *
- Is ventilation adequate to minimize odors, vapors, and condensation in processing areas? *
- Are screens or other protection provided against pests where openings to the outside exist? *
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