GMP Audit - Powders

• Site conducted

  Select

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

PPE

• Hair nets worn correctly by staff with no exposed hair

  Compliant

  Non Compliant

• Company uniforms worn and in clean / sound condition

  Yes

  No

  N/A

• No loose items worn that could enter raw material

  Compliant

  Non Compliant

• No inappropriate jewellery / cosmetics worn (earrings, watches, false fingernails)

  Compliant

  Non Compliant

• Staff complying to Eating / Drinking GMP policy: No eating, drinking (apart from supplied drinking water fountains / cups) or chewing in production area

  Compliant

  Non Compliant

Powder Room (non-allergenic raw material)

• Powder room clean & tidy. No evidence of gross build up &/or mould on walls, fixtures, ceiling, power points, racking etc.

  Yes

  No

  N/A

• Powder Room - Structure such as Walls, floor, ceiling, doors etc. are in good condition

  Yes

  No

  N/A

• Correct colour coded cleaning tools are available, adequate, properly stored and clean when not in use

  Compliant

  Non Compliant

• Correct colour coded utensils / equipment used in room for handling non-allergenic raw material.

  Compliant

  Non Compliant

• Utensils / Equipment are clean, in good condition with no evidence of gross build up or damage

  Yes

  No

  N/A

• Underside of equipment, scales, trolleys etc are clean with no evidence of gross build up

  Yes

  No

  N/A

• Storage tubs for raw material clean with no evidence of gross build up

  Yes

  No

  N/A

• Storage tubs correctly identified when in use for the applicable raw material

  Yes

  No

  N/A

• Large (grey) IBC tubs that are used to store & transfer raw material are visually clean with no evidence of debris &/or waste build up.

  Compliant

  Non Compliant

• Allergenic raw material, equipment &/or tools are not stored / used in non allergenic powder room

  Safe

  At Risk

  N/A

• Waste not lying on floor &/or waste bins full & overflowing

  Compliant

  Non Compliant

• Correct colour coded tools available, used to remove waste materials. Equipment stored appropriately when not in use

  Yes

  No

  N/A

• No evidence of pest activity

  Compliant

  Non Compliant

• Raw material Packaging compliant with no evidence of damage for potential cross contamination

  Compliant

  Non Compliant

• Raw Material shelf life is acceptable. In the event of expired RM it has been appropriately identified (QA Hold) and isolated

  Compliant

  Non Compliant

• Plastic drinking bottles & wooden items excluded from area (i.e. pallets, brooms, tools)

  Compliant

  Non Compliant

• No electronic devices (i.e. mobile phones) are being used by staff in the Powders room

  Compliant

  Non Compliant

• Pens used are metal detectable

  Yes

  No

  N/A

• Area compliant to 5s

  Good

  Fair

  Poor

  N/A

Allergen Room

• Allergen room clean & tidy. No evidence of gross build up &/or mould on walls, fixtures, ceiling, power points, racking etc.

  Yes

  No

  N/A

• Allergen Room - Structure such as Walls, floor, ceiling, doors etc. are in good condition

  Yes

  No

  N/A

• Correct colour coded utensils / equipment used in room for handling Allergenic raw material.

  Compliant

  Non Compliant

• Utensils / Equipment are clean, in good condition with no evidence of gross build up or damage

  Yes

  No

  N/A

• Underside of equipment, scales, trolleys etc are clean with no evidence of gross build up

  Yes

  No

  N/A

• Storage tubs for raw material clean with no evidence of gross build up

  Yes

  No

  N/A

• Storage tubs correctly identified when in use for the applicable raw material

  Yes

  No

  N/A

• Non-allergenic raw material, equipment &/or tools are not stored / used in allergenic powder room

  Compliant

  Non Compliant

• Waste not lying on floor &/or waste bins full & overflowing

  Compliant

  Non Compliant

• Correct colour coded cleaning tools are available, adequate, properly stored and clean when not in use

  Yes

  No

  N/A

• No evidence of pest activity

  Compliant

  Non Compliant

• Raw material Packaging compliant with no evidence of damage for potential cross contamination

  Compliant

  Non Compliant

• Raw Material shelf life is acceptable. In the event of expired RM it has been appropriately identified (QA Hold) and isolated

  Yes

  No

  N/A

• Plastic drinking bottles & wooden items excluded from area (i.e. pallets, brooms, tools)

  Compliant

  Non Compliant

• Pens used are metal detectable

  Yes

  No

  N/A

• Area compliant to 5s

  Good

  Fair

  Poor

  N/A

• Cleaning master schedule (AFQA-F-0021) in place, available & completed correctly for Powder / Allergen Batching section

  Yes

  No