cGMP Audit - Production (Weekly)

• Site

  Select

• Conducted on

  Date

• Prepared by

Entrance

• PPE are available, placed or stored at the designated location

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Food Bath, Sink, Hand Soap/Sanitizer/Towels Dispensers, Water Taps, Hand Dryers are clean and functional

  Select Yes No N/A

  • Yes
  • No
  • N/A

• The signs of entry polices on wall are updated and followed

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Entry Doors are sealed and kept closed when not in used

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Changeroom is clean and neat. Bins are not overflow

  Select Yes No N/A

  • Yes
  • No
  • N/A

Wall/Doors/Floor/Drains

• Doors, windows and exterior openings are sealed or screened and kept close when not in used to prevent pest entry

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Doors/Plastic Curtains are clean without damaged, funtional, no mold detected

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Walls / Windows and Ceilings are in good state of repair with no damage, without peeling paint, clean, no mould detected

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Refrigeration Fans are clean, free of damage, funtional, no mould detected

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Lights are in good condition and are shielded, functioning and bright (> 600 lux is recommended in production)

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Overhead (piping, fans, door frames etc.) over production or storage zones are free of dust accumulation, condensation water removed timely, no mould detected

• Floors / Platfrom are properly sealed, no cracked or damaged, pooling water removed timely with reasonable clean state

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Drains are no block, no back flow, waste removed timely

  Select Yes No N/A

  • Yes
  • No
  • N/A

Personnel Behaviours

• Everyone conducts hand washing and sanitising, wearing the correct PPE and not wearing unauthorized jewellery prior to entering production

  Select Yes No N/A

  • Yes
  • No
  • N/A

• No eating, No smoking, No drinking, No Food, No chewing gum and No person items in production area

  Select Yes No N/A

  • Yes
  • No
  • N/A

• All wounds or injuries are adequately covered and protected

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Operators are wearing gloves when handling products, gloves changed after touch any non-product contact surface, every break and when glove damaged

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Operators do not have acrylic nails or nail polish that contains glitter or stones of any kind?

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Product Package, WIP, Finished Goods, clean Crates, Product Contact Equipment Parts, Water Hoses and Product Contact Surface Cleaning Tools are kept off floor/platform or any unclean surface by operators

  Select Yes No N/A

  • Yes
  • No
  • N/A

• QA inspection and record are completed and signed timely

  Select Compliant Partial Compliant Non-Compliant NA

  • Compliant
  • Partial Compliant
  • Non-Compliant
  • NA

Equipment

• Fixed Equipment and Mobile Equipment are in good state of repair, clean, no leaking, no rust, no scratching, no damaged present and no missing screws, nuts, or bolts

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Product and washing water direct contact surface of the Equipment are made by food grade material, with smooth sealing, flat and easy to clean, free of the scratching, grinding or product residue trapping risks

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Hose Reels, Cleaning Hoses and Airlines are no damaged and no leaking, functional, off floor hock or holder is setup at use point

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Pallets are in good state and are heat treated? Damaged pallets are removed from production or storage area in time manner

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Permitted Tools are in good sate, toolbox is inspected daily, missing tool or broken tool is followed up and recoreded

  Select Yes No N/A

  • Yes
  • No
  • N/A

• QA In-process check equipment (Balances, Weights, Water Activity Meters, Hardness Tester, Friability Tester, Metal Detector, etc.) are in good condition? In calibration? Logbooks are maintained and follow GDP?

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Use food grade lubricant only, no excessive grease detected on the equipment

  Select Yes No N/A

  • Yes
  • No
  • N/A

• No temporary repairs on equipment (tape, zip ties, etc. )

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Tools used for cleaning are in good state, no damaged, suitable to use and free product contamination risk

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Standby Equipment, Spare Parts and Production Utensils are clean and stored seperated to prevent away from cross-contamination risk, covered as reqruied

  Select Yes No N/A

  • Yes
  • No
  • N/A

Line Cleanrance & Storage

• Line clearance and changeover are conducted properly, no last batch product and packaging left at the production line

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Products, WIP or Packaging with Quality or Food Safety concerned are isolated and labelled properly

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Items not related to production are not stored within production

  Select Yes No N/A

  • Yes
  • No
  • N/A

• The organic crates and organic products are separated to conventional products

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Allergen Products and Batch Records are properly identified and labeled in production

  Yes

  No

  N/A

• Storage Rack and Storage Room are clean and neat, containers or itmes are clean, labelled and stored properly

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Items on working station and QC station are clean and neat, itmes are clean, labelled and stored properly

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Expired Materials are properly identified and in quarantine for destruction?

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Part opened or used package and WIP are labelled with item description and batch information

  Select Yes No N/A

  • Yes
  • No
  • N/A

• There is no overflow in the bin or container for waste collection

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Labels are collected or kept at designated location prevent from lost or contamination to product

  Select Yes No N/A

  • Yes
  • No
  • N/A

Pest Control

• Pest Control facilities are located at designated spot matching to Pest Map and functioning

  Select Yes No N/A

  • Yes
  • No
  • N/A

• No Pest activities detected

  Select Yes No N/A

  • Yes
  • No
  • N/A