GMP AUDIT CHECKLIST

Title Page

Section 1: PERSONNEL HYGIENE

Are employees washing and sanitizing their hands before starting work each day, after using the restroom, after breaks and whenever hands may be contaminated?
Is hand washing stations clean? Is hand sanitizers are in good condition?
Are employees with infected wounds or exhibiting signs of food borne illness excluded from operations involving direct and indirect food contact?
Is jewellery confined to a plain wedding ring?
Is smoking, eating, chewing and drinking confined to designated areas?
All employees must wear the correct, clean, protective clothing including hair nets & over beard in the correct manner.
All personnel have to store there personnel belongings away from the work place& not supposed to wear watches or jewelery or earrings.
Contractors must comply with company regulations.
No cross contamination risk observed related to personnel hygiene (dirty clothing, shoes, etc).
Is there any evidence of individuals working within the area wearing strong smelling cosmetic products or any uncovered bodily accessory that has the potential to come loose (e.g. false fingernails, false eye lashes)?

Section 2 : CLEANING & SANITATION

Cleaning regimes for equipment are in place and followed. Records to support this must be available for review.
Cleaning regimes for floors, walls etc are in place and followed. Records to support this must be available for review.
Is Cleaning effective in the area (spillages cleaned immediately, no packaging cups or foils, no product deposits, etc)?
Correct cleaning utensils for all cleaning purposes must be available and used in the appropriate manners and stored properly when not in use.
Are waste and garbage frequently removed from production and storage areas?
Are proper containers for waste disposal available?
Are Spare parts, flow blends and other cleaning materials stored properly, when not in use?
Are all forklifts in Loading, unloading, Cold store, PM, RM, and FG area are cleaned and free from dust/rust/ etc?
Do floor drains appear clean, free from odours and well maintained?
Are the warehouse areas organized - i.e. FG, RM, PM, Chemicals, and Spare parts stored in a neat and tidy fashion?
Is colour coding for cleaning utensils followed? If yes, please check its effectiveness
Are empty pallets cleaned and in good repair condition and kept in the designated area?

Are all pest control programmes followed regularly?
Are plant and storage areas free of insects/rodents/birds or any evidence of them?
Are equipment's free of insects/rodents/birds or any evidence of them?
Are Insect-o-cutors in correct position, operational and cleaned regularly?
Are all doors kept closed (Self closing) when not in use? Are door seals intact?
Are all pest control devices identified by a number or other code? Are all pest control devices properly installed and secured?

Are there any opened materials observed?
Doors and windows secured - looking in good condition- no birds nest on the ceiling.
Primary/Secondary packaging materials are stored in marked designated areas (closures, cartons, preforms, films, pallets).
Are all WIP materials returned from Production stored in one designated location and properly covered to avoid any cross contamination?
Is any broken glass or Perspex cover observed in the department? Are glass policy checks performed on weekly basis?
Walls, doors and windows are clean with no evidence of contamination or cross contamination.
Are there any birds' droppings found in the area?
Are there any unwanted materials in the Loading, unloading, Cold store, PM, RM, and FG area?
Do controlling of safety knives or scissors maintained in the department?

Is their standing water found on the floors? Are there any damaged at floors observed?
Is Access control to the warehouse area available?
Are Gasoline- or diesel-powered fork-lift trucks are used in the warehouse and controlled?
Is Adequate lighting available in warehouse areas?
Is proper signages related to safety and Quality maintained in the area?
Is the store temperature & humidity controlled and monitored?
Is Allergen materials identified very clearly in the storage area? Are allergens stored separately to non-allergen areas?
Is FEFO/FIFO maintained effectively?
Are all the primary packaging materials properly maintained to avoid any cross contamination?
Are all Walls/Floors/Ceiling/Drains/Equipment/External Areas kept in a good condition?
Are all the documents(logs/records) filled correctly and completely for compliance? Are these documents stored properly?
Do we have continuous monitoring of temperature for chilled and frozen stores?