GMP/Bag Audit

• Document No.

• Site

• Audit Area

• Conducted on

  Date

• Prepared by

• Area Supervisor

Personal hygiene

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

  5

  4

  3

  2

  1

GMP

• Product handling/surfaces

  5

  4

  3

  2

  1

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

  5

  4

  3

  2

  1

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

  5

  4

  3

  2

  1

• Waste control - bins closed, no loose rubbish

  5

  4

  3

  2

  1

• Metal detectable pens/markers etc.

  5

  4

  3

  2

  1

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

  5

  4

  3

  2

  1

Hygiene and sanitation

• Hygiene of control room & red line areas

  5

  4

  3

  2

  1

• No leaks

  5

  4

  3

  2

  1

• No foreign materials or unnecessary items in the area

  5

  4

  3

  2

  1

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

  5

  4

  3

  2

  1

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

  5

  4

  3

  2

  1

• General hygiene/cleanliness of the area

  5

  4

  3

  2

  1

Pest control

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

  0

  1-5

  6-10

  11+

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

  5

  4

  3

  2

  1

• Condition of pest control devices acceptable

  5

  4

  3

  2

  1

Bag Audit Extraneous Matter

• Number of extraneous matter items found in the area.

  0-10

  11-50

  51-100

  100+

• Types of items found

• Plastic

  0

  1-5

  6-10

  11+

• Paper/Cardboard

  0

  1-5

  6-10

  11+

• Metal

  0

  1-5

  6-10

  11+

• Wood

  0

  1-5

  6-10

  11+

• Other

  0

  1-5

  6-10

  11+

• Comments

  Media

Previous Audits

• Have items from previous GMP been corrected/actioned?

  5

  4

  3

  2

  1

Overall score

• >80 Excellent

  Yes

  N/A

• 70-79 Satisfactory (but room for improvement)

  Yes

  N/A

• 60-69 Unsatisfactory- corrective action required

  Yes

  N/A

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

  Yes

  N/A