Information
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Document No.
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Site
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Audit Area
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Conducted on
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Prepared by
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Area Supervisor
Personal hygiene
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Correct hygiene procedures being followed- no jewellery, uniform correct, hair covered.
GMP
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Product handling/surfaces
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Cleaning equipment -stored correctly, correct color, good condition.
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Chemical control, food grade chemicals, stored correctly, labelled correctly
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Waste control - bins closed, no loose rubbish
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Metal detectable pens/markers etc.
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Knifes - approved knives and scissors only in the area.
Hygiene and sanitation
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Hygiene of control room & red line areas
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No leaks
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No foreign materials or unnecessary items in the area
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Everything in its place. Eg tools returned, shadow boards complete.
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General repair of the area. Eg cracks, holes, flaking paint, rust marks, broken glass etc.
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General hygiene/cleanliness of the area
Pest control
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Absence of pests - number of insects/pests found in the area.
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No pest access points (ie holes in walls, door jams.)
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Condition of pest control devices acceptable
Bag Audit Extraneous Matter
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Number of extraneous matter items found in the area.
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Types of items found
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Plastic
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Paper/Cardboard
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Metal
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Wood
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Other
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Comments
Previous Audits
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Have items from previous GMP been corrected/actioned?
Overall score
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>80 Excellent
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70-79 Satisfactory (but room for improvement)
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60-69 Unsatisfactory- corrective action required
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<59 Unsuitable for production of MG products- immediate corrective action and AR submission required.