GMP Audit - Dispatch Warehouse

• Site conducted

  Select

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

Finished Goods Storage - Site 2

• Warehouse is clean & tidy with no evidence of gross build up. Includes but not exclusive to: walls, overhead, fixtures, racking.

  Yes

  No

  N/A

• No evidence of food stuff &/or waste build up present on floor &/or racking

  Compliant

  Non-Compliant

  N/A

• Finished product packaging, vessels are clean and show no evidence of gross build up

  Compliant

  Non-Compliant

  N/A

• Underside of equipment is clean (tables, trolleys, tubs etc.)

  Compliant

  Non-Compliant

  N/A

• Waste bins are in good condition and kept clean with no evidence of gross build up

  Compliant

  Non-Compliant

  N/A

• Waste bins are not full and overflowing

  Compliant

  Non-Compliant

  N/A

• No evidence of pest activity sighted in Ambient Warehouse area, Anteroom &/or Chiller storage

  Compliant

  Non-Compliant

  N/A

• All internal pest traps are appropriately secured & identified (ID# 10, 10a, 11, 12 & 13)

  Compliant

  Non-Compliant

  N/A

• Internal pest traps show no signs of damage, deterioration &/or activity

  Compliant

  Non-Compliant

  N/A

• Co2 analyser clean & in good working order. Sanitiser solution available to ensure sterility of parts / tools is maintained when not in use

  Yes

  No

  N/A

• Chemicals correctly stored, secured and identified

  Yes

  No

  N/A

• Cleaning tools are available, adequate, properly stored and clean when not in use

  Yes

  No

  N/A

• Packaging stored correctly, secured with no evidence of damage

  Yes

  No

  N/A

• All access doors are in working order and closed when not in use

  Yes

  No

  N/A

• Lights throughout storage areas (Dry, Chiller, Tote Co2 testing) are covered, in working order with no damage evident

  Yes

  No

  N/A

• Temperature of Finished Product Chiller Storage room compliant (Range 0°C to +15°C)

  Yes

  No

  N/A

• Record the temperature of the Finished Product Chiller

• Unisex toilet clean & tidy. No evidence of gross build up

  Compliant

  Non-Compliant

  N/A

• Unisex toilet / fixtures in good condition. No evidence of major damage

  Yes

  No

• Hand wash soap and drying facilities available in unisex toilet

  Yes

  No

  N/A

• Locker / change room clean & tidy

  Yes

  No

  N/A

• Lunchroom clean & tidy. Includes but not exclusive to: Microwave, fridge, stools, sink, bench

  Yes

  No

  N/A

• Lunchroom in good condition. No evidence of major damage

  Compliant

  Non Compliant

Production Loading Dock - Site 1

• Finished product loading dock clean & tidy with no evidence of rubbish / debris build up

  Yes

  No

  N/A

• Cleaning utensils available in area to maintain cleaning.

  Yes

  No

  N/A

• Cleaning tool are maintained in clean, sound condition and stored correctly when not in use

  Yes

  No

  N/A

Verification - Auditor to sight

• 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

• No evidence of leaking packaging / vessels. Tote gate valve lever is correctly closed.

  Compliant

  Non Compliant

• Dispatch operators are following prescribed WI practices (AFDIS-WI-0002 Step 6.3) for inspection of the Tote Gate valve cleanliness & a sanitised soaked sponge shows no evidence of leakage &/or soiling

  Compliant

  Non Compliant

• Finished product correctly identified and secured appropriately with tamperproof security tape (tote gate valve / BIB pallets

  Compliant

  Non Compliant

• Sterility is maintained by despatch operator during connection and manipulation of totes with PRV gauge when testing Co2 levels (refer Work instruction AFDIS-WI-0002)

  Compliant

  Non Compliant

• Calibration of Co2 Analyser is being conducted periodically and correctly as per WI AFDIS-WI-0001.

  Compliant

  Non Compliant

• Cleaning master schedule (AFQA-F-0021) in place, available & completed correctly for Dispatch warehouse

  Yes

  No