A generic GMP self-audit checklist for food manufacturers, organized around the themes of 21 CFR Part 117, Subpart B. It is a best-practice starting point, not legal advice; tailor it to your products, processes, and the regulation text itself. Score each item Pass / Fail / N/A, note evidence, and assign an owner and due date to every failure.
1. Personnel (117.10) and training (117.4)
- ☐ Written hygiene policy covers illness reporting, exclusion of sick employees, and return-to-work rules.
- ☐ Clean outer garments, hair restraints, and beard covers worn correctly in production areas.
- ☐ Hand-wash stations stocked, functional, and used at entry and after contamination events.
- ☐ Jewelry, food, drink, and personal items controlled per policy in production areas.
- ☐ Glove use and glove condition consistent with policy for food-contact work.
- ☐ All employees trained in food hygiene and food safety appropriate to their role; training documented and current.
- ☐ Supervisors demonstrably enforcing hygiene rules on the floor.
2. Plant and grounds (117.20)
- ☐ Grounds free of harborage: waste, weeds, standing water, unused equipment.
- ☐ Building exterior sealed: doors, docks, screens, and wall penetrations pest-proofed.
- ☐ Layout separates raw from finished operations sufficiently to prevent cross-contamination.
- ☐ Floors, walls, and ceilings in production areas intact and cleanable; no flaking paint or condensation over exposed product.
- ☐ Lighting adequate and shielded/shatter-protected over exposed product zones.
- ☐ Ventilation adequate to control dust, odors, and condensation.
3. Sanitary operations (117.35)
- ☐ Master sanitation schedule exists, covers all areas and equipment, and is up to date.
- ☐ Cleaning and sanitizing procedures specify method, chemical, concentration, and frequency.
- ☐ Cleaning compounds and toxic chemicals labeled, stored away from product, and access-controlled.
- ☐ Pest control program in place with documented monitoring, device maps, and trend review.
- ☐ Pre-operational inspection verifies cleaning effectiveness before production starts.
- ☐ Food-contact and non-food-contact surfaces cleaned at defined frequencies with records.
4. Sanitary facilities and controls (117.37)
- ☐ Water supply adequate and from a safe source; test records available where required.
- ☐ Plumbing prevents backflow and cross-connection between potable and non-potable systems.
- ☐ Toilet and hand-washing facilities adequate, maintained, and not opening directly onto exposed product areas without controls.
- ☐ Sewage and rubbish disposal do not create contamination risk; waste containers covered and removed at adequate frequency.
- ☐ Drains flowing, trapped, and cleanable; no pooling in production areas.
5. Equipment and utensils (117.40)
- ☐ Food-contact surfaces are corrosion-resistant, non-toxic, non-absorbent, and cleanable.
- ☐ Equipment installed with access for cleaning around, under, and inside.
- ☐ No product-contact risk from lubricants, hydraulic fluids, flaking material, or loose fasteners.
- ☐ Instruments used for food safety measurements (thermometers, pH meters, scales) calibrated on schedule with records.
- ☐ Preventive maintenance schedule current; temporary repairs (tape, wire) absent from product zones.
- ☐ Compressed air or other gases contacting food filtered/treated appropriately.
6. Processes and controls (117.80)
- ☐ Incoming raw materials and ingredients inspected, approved, and stored to prevent contamination and allergen cross-contact.
- ☐ Allergen controls in place: segregation, scheduling, changeover cleaning, and label verification.
- ☐ Time and temperature controls defined and monitored where needed (refrigeration, cooking, cooling, holding).
- ☐ Work-in-process protected from contamination (foreign material, drip, splash) at each step.
- ☐ Rework handled under defined, documented conditions.
- ☐ Nonconforming product identified, segregated, and dispositioned with records.
- ☐ Batch/lot coding applied and legible to support traceability and recall.
7. Warehousing and distribution (117.93)
- ☐ Finished goods stored under conditions that protect against physical, chemical, and biological contamination.
- ☐ Temperature-controlled storage monitored with records and alarm/response procedures.
- ☐ Stock rotation (FIFO/FEFO) practiced; damaged or expired product segregated.
- ☐ Shipping vehicles inspected for cleanliness and condition before loading, with records.
8. Records and self-audit discipline (Subpart F, best practice)
- ☐ Records created at the time of the activity, legible, indelible, dated, and signed or initialed.
- ☐ Records retained per your retention policy (generally at least two years) and retrievable on request.
- ☐ Corrective actions from prior audits and inspections closed, with verification evidence.
- ☐ Internal GMP audit completed on schedule, findings logged, owners and due dates assigned.
- ☐ Management reviews audit results and trends at a defined frequency.