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 machines deep cleaned? Are records available?
Is regular fogging conducted? Are records available for review?
Do floor drains appear clean, free from odours and well maintained?
Is the filling area organized - i.e. equipment and spares stored in a neat and tidy fashion?
Do high level areas including overhead pipes, ducts, fans, etc. appear clean?
Is colour coding for cleaning utensils followed? If yes, please check its effectiveness
Condition of water hoses used for cleaning.

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 any loose nuts/bolts/washers observed near the filling machines?
Are any containers of Ingredients, In- process materials and finished products kept open?
Are any wooden pallets entering into the departments (high care production areas)?
Are any miscellaneous small engineering items, screws, nuts, washers etc. are stored in proper containers?
Is any broken glass or Perspex cover observed in the department? Are glass policy checks performed on weekly basis?
Are process equipment's closed to avoid any foreign body contamination from environment?
Is Air ventilation system available and working effectively to avoid any cross contamination in processing area?
Equipment segregation — people, materials, equipment and tools (including use of dedicated tools) are organized.
Are all packaging materials and engineering equipment's removed after breakdown repairing of a machine?
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 filling and downline area available?
Is there any leakage of juice/water/air/steam/nitrogen/lubrication/ greases etc?
Is proper signages related to safety and Quality maintained in the area?
Is Adequate lighting available in filling areas?
Are all equipment's are cleaned and free from rust/mold /dust?
Are there any leaks/ condensation from the ceiling or over head pipeworks?
Is the room temperature & humidity controlled?
Do maintenance team following all GMP practices?
Is posItive pressure maintained in the filling area?
- N/A
- Yes
- No (1)
- No (2-3)
- No (+3)
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?
Any other points observed?