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).
All Employees abide to wearing clean uniform, hairnets- incase of need.

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?
No equipment or supplies are stored outside, in an open area. In case of temporary storage, the equipment/supplies are protected, placed on labeled, dedicated areas.
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
Is the Utilities area organized - i.e. equipment and spares stored in a neat and tidy fashion?
Do Eye rinsers and safety showers working as intended? They should be easily accessible.

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 utilities machines?
Are any miscellaneous small engineering items, screws, nuts, washers etc. are stored in proper containers?
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?
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?

Is their standing water found on the floors? Are there any damaged at floors observed?
Access to the utilities is controlled.
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?
PPE available and used when required.
Are all equipment's are cleaned and free from rust/mold /dust?
Adequate lighting provided in utilities?
There are no evidence of leaks or drips at the pipe connections of pipes and taps; no temporary fixes.
Do maintenance team following all GMP practices?
Are all Walls/Floors/Ceiling/Drains/Equipment/External Areas kept in a good condition?
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?