Information

  • Document No.

  • Site

  • Audit Area

  • Conducted on

  • Prepared by

  • Area Supervisor

Personal hygiene

  • Correct hygiene procedures being followed- no jewellery, uniform correct, hair covered.

GMP

  • Product handling/surfaces

  • Cleaning equipment -stored correctly, correct color, good condition.

  • Chemical control, food grade chemicals, stored correctly, labelled correctly

  • Waste control - bins closed, no loose rubbish

  • Metal detectable pens/markers etc.

  • Knifes - approved knives and scissors only in the area.

Hygiene and sanitation

  • Hygiene of control room & red line areas

  • No leaks

  • No foreign materials or unnecessary items in the area

  • Everything in its place. Eg tools returned, shadow boards complete.

  • General repair of the area. Eg cracks, holes, flaking paint, rust marks, broken glass etc.

  • General hygiene/cleanliness of the area

Pest control

  • Absence of pests - number of insects/pests found in the area.

  • No pest access points (ie holes in walls, door jams.)

  • Condition of pest control devices acceptable

Bag Audit Extraneous Matter

  • Number of extraneous matter items found in the area.

  • Types of items found

  • Plastic

  • Paper/Cardboard

  • Metal

  • Wood

  • Other

  • Comments

Previous Audits

  • Have items from previous GMP been corrected/actioned?

Overall score

  • >80 Excellent

  • 70-79 Satisfactory (but room for improvement)

  • 60-69 Unsatisfactory- corrective action required

  • <59 Unsuitable for production of MG products- immediate corrective action and AR submission required.

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