Title Page
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Document No.
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Audit Title
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
Previous inspection/corrective & preventative action review
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Has the previous month's inspection been reviewed by the management team?
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Have all corrective/preventative actions been implemented from the previous inspection?
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Corrective/preventative action items are not past due or behind schedule?
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Have temporary measures been implemented for corrective actions that require capital projects or otherwise cannot be implemented immediately?
Exterior building & grounds
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Litter free?
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Adequate drainage?
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No evidence of off odors?
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All doors and windows closed with no visible gaps?
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Building entrances secured?
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Grass and weeds controlled?
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Wastewater treatment system locked to restrict access?
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Review of wastewater treatment charts show no violations?
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Rodent stations properly working, clean and in proper locations?
Finished product warehouse
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Clean and orderly?
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No evidence of off odors?
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18" warehouse buffer zone maintained?
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All lights functional, with no missing bulbs?
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No evidence of product spills. Any spills are cleaned immediately.
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All product properly sealed and packaged?
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Proper product identification is visible?
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Rodent stations properly working, clean and in proper locations?
Shipping and receiving docks area
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Clean and orderly?
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No evidence of off odors?
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All lights functional, with no missing bulbs?
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18" warehouse buffer zone maintained?
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Product in quarantine area clearly labeled?
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All product properly sealed and packaged?
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Proper product identification is visible?
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Rodent stations properly working, clean and in proper locations?
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Review of shipping and receiving paperwork shows no gaps or missing information?
Incoming raw material and bulk powder storage area
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Clean and orderly?
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No evidence of off odors?
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18" warehouse buffer zone maintained?
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All lights functional, with no missing bulbs?
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All product properly sealed and packaged?
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Proper product identification is visible?
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Rodent stations properly working, clean and in proper locations?
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All entrances can be secured properly?
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Raw materials and key expiration check- randomly choose one raw material and one key from warehouse shelves, refrigerator, or drum racks and inspect for compliance with expiration date program (2.4.9 Stock Rotation). <br><br>Take a photo of RM / key label. Are the selected items in compliance?<br><br>Note discrepancies.
General warehouse
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Clean and orderly?
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No evidence of off odors?
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All products stored on pallets in an orderly manner to reduce risk for damage/cross contamination?
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All lights functional, with no missing bulbs?
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All product properly sealed and packaged?
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Rodent stations properly working, clean and in proper locations?
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Proper product identification is visible?
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Laboratory storage racks orderly and clean?
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Glass pouring station kept neat and orderly to prevent cross contamination/adulteration.
Flammable warehouse
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Clean and orderly?
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No evidence of off odors?
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All lights functional, with no missing bulbs?
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All product properly sealed and packaged?
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Rodent stations properly working, clean and in proper locations?
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Proper product identification is visible?
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All products stored on pallets in an orderly manner to reduce risk for damage/cross contamination?
Refrigerated storage
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Clean and orderly?
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No evidence of off odors?
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All product properly sealed and packaged?
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No product spills?
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Proper product identification is visible?
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All products stored on pallets in an orderly manner to reduce risk for damage/cross contamination?
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Cold box temperature recording log in order?
Boiler and cleaning chemicals area
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Clean and orderly?
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Compliance with GMP for buckets and brushes?
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All food grade material separated, identified, and stored properly?
Custodial closet
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Clean and orderly?
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Compliance with GMP for buckets and brushes?
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All food grade material separated, identified, and stored properly?
Liquid production room
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Clean and orderly?
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No evidence of off odors?
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All lights functional, with no missing bulbs?
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Adequate drainage and cleanable floor surface?
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All walls, ceiling, and floor cleanable?
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No signs of flaking or peeling paint?
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Processing equipment clean and sanitary?
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Covers in place over production equipment?
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Mixing utensils and equipment clean and stored in a sanitary manner?
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All fittings, spouts, clamps, gaskets, and filters stored in a clean and sanitary manner?
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Cleaning supplies and equipment properly stored?
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Compliance with GMP for buckets and brushes?
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Review of MSS records show no deficiencies?
Powder production room
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Clean and orderly?
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No evidence of off odors?
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All lights functional, with no missing bulbs?
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Adequate drainage and cleanable floor surface?
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All walls, ceiling, and floor cleanable?
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No signs of flaking or peeling paint?
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Processing equipment clean and sanitary?
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Covers in place over production equipment?
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Mixing utensils and equipment clean and stored in a sanitary manner?
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All fittings, spouts, clamps, gaskets, and filters stored in a clean and sanitary manner?
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Cleaning supplies and equipment properly stored?
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Compliance with GMP for buckets and brushes?
Emulsion production room
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Clean and orderly?
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No evidence of off odors?
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All lights functional, with no missing bulbs?
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Adequate drainage and cleanable floor surface?
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All walls, ceiling, and floor cleanable?
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No signs of flaking or peeling paint?
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Processing equipment clean and sanitary?
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Covers in place over production equipment?
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Mixing utensils and equipment clean and stored in a sanitary manner?
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All fittings, spouts, clamps, gaskets, and filters stored in a clean and sanitary manner?
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Cleaning supplies and equipment properly stored?
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Compliance with GMP for buckets and brushes?
Break room, restrooms and locker room areas
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Clean and orderly?
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Refrigerator is orderly and clean?
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All trash disposed of properly?
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Employee locker area is orderly and clean?
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No evidence of food stored in lockers?
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Toilets are clean and orderly?
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Paper towels, soap, and warm water available for proper hand washing?
Personal hygiene compliance observations
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Hairnets and beard nets worn properly?
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Uniforms and lab coats are clean and worn properly?
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Everyone is washing and sanitizing hands?
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No one is wearing jewelry in plant?
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Shoes and boots are clean and in good condition?
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Work areas are clean and orderly?
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Color coding for buckets and utensils being followed per the policy guidelines?
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No injuries or illnesses are present in personnel in the plant?
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No tobacco, gum, candy, drinks, false fingernails, fingernail polish, items in shirt pockets, and medications are found in plant?