Information
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Audit Title
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Document No.
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
Facility and Grounds
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Anti-siphon devices on water outlets?<br>21 CFR 111.15(f(5))
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Shrubs are spaced away from outer walls?<br>21 CFR 111.15(a(1))
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Rubbish is contained and grounds are clean?<br>21 CFR 111.15(a(1))
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Entries into the facility are designed to prevent pest from entering the facility?<br>21 CFR 111.15(d(2))
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Restrooms clean and sanitized?<br>21 CFR 111.15(h)
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Company has and follows SOPs for cleaning and maintenance of the facility and grounds?<br>21 CFR 111.16
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Other GMP issues?
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Misc. Pictures
Receiving Department
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Quarantine area controlled or locked?<br>21 CFR 111.120(e), 111.155, 111.160, 111.165, 111.170, 111.370, 111.425, 111.510
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Quarantine area clean & organized?<br>21 CFR 111.15(b(1))
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Company has an acceptable area or room for taking samples?
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Receiving log is documented correctly and up to date?<br>21 CFR 111.180(b(2))
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Raw Material Check-in Log is documented correctly and up to date?<br>21 CFR 111.180(b(2))
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Packaging Material Check-in Log is documented correctly and up to date?<br>21 CFR 111.180(b(2))
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Label Check-in Log is documented correctly and up to date?<br>21 CFR 111.180(b(2))
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Finished Product Check-in Log is documented correctly and up to date?<br>21 CFR 111.180(b(2))
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Company has and follows SOPs for receiving and quarantine?<br>21 CFR 111.153
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Other GMP issues?
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Misc. Pictures
Warehouse
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Doors leading to outside are closed?<br>21 CFR 111.15(d(2))
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All materials are stored up off the floor?<br>21 CFR 111.365(f)
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All components bear a release sticker?<br>21 CFR 111.155(c(3))
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All containers are properly closed?<br>21 CFR 111.365(f)
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Warehouse floor is clean and free of debris?<br>21 CFR 111.15(b(1))
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ID tags are visible from isles?<br>21 CFR 111.20(c(1))
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All pallets identified with proper tags?<br>21 CFR 111.20(c(1))
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Empty containers have labels removed or defaced?
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Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)
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Tube guards on lights and all lights working properly?<br>21 CFR 111.20(f)
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In process materials are clearly labeled?<br>21 CFR 111.20(c(1))
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Empty pallets are properly and neatly stored?
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Pest control devices are not damaged and traps in place?<br>21 CFR 111.15(d(2))
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Scales, if applicable, have a current calibration sticker?<br>21 CFR 111.30(c)
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Pallet racks are mounted away from walls to allow for cleaning between walls and racks?<br>21 CFR 111.20(b)
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Tops of all containers are free from debris and residual dust?<br>21 CFR 111.15(b(1))
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Other GMP issues?
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Misc. Pictures
Weighing Department
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Floors/walls clean and undamaged?<br>21 CFR 111.15(b(1)), 111.15(b(2))
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Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)
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Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))
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In process product is covered and labeled?<br>21 CFR 111.460(a)
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Only one product in a room at a time?<br>21 CFR 111.460(a)
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Scales have a current calibration sticker?<br>21 CFR 111.30(c)
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Daily Scale Check is documented and up to date?<br>21 CFR 111.30(c)
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Paperwork properly documented?<br>21 CFR 111.260(j)
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Room Cleaning and Use Records are up to date and completed correctly?
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Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))
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Component Control Cards up to date?
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Other GMP issues?
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Misc. Pictures
Blending/Compounding Department
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Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))
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Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)
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Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))
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Machines and rooms properly identified?<br>21 CFR 111.365(k)
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In process product is covered and labeled?<br>21 CFR 111.460(k)
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Only one product in a room/area at a time?<br>21 CFR 111.460(a)
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Scales have a current calibration sticker?<br>21 CFR 111.30(c)
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Daily Scale Check is documented and up to date?
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Paperwork properly documented?<br>21 CFR 111.260(j)
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Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))
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Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))
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Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)
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Other GMP issues?
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Misc. Pictures
Tablet Department
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Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))
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Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)
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Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))
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Machines and rooms properly identified?<br>21 CFR 111.365(k)
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In process product is covered and labeled?<br>21 CFR 111.460(k)
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Only one product in a room at a time?<br>21 CFR 111.460(a)
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Scales have a current calibration sticker?<br>21 CFR 111.30(c)
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Daily Scale Check is documented and up to date?
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Paperwork properly documented?<br>21 CFR 111.260(j)
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Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))
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Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))
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Extra parts/machinery covered and tagged?<br>21 CFR 111.27(d)
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Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)
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Other GMP issues?
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Misc. Pictures
Tablet Coating Department
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Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))
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Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)
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Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))
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Machines and rooms properly identified?<br>21 CFR 111.365(k)
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In process product is covered and labeled?<br>21 CFR 111.460(k)
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Only one product in a room at a time?<br>21 CFR 111.460(a)
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Scales have a current calibration sticker?<br>21 CFR 111.30(c)
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Daily Scale Check is documented and up to date?
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Paperwork properly documented?<br>21 CFR 111.260(j)
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Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))
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Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))
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Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)
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Other GMP issues?
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Misc. Pictures
Hard Shell Encapsulation Department
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Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))
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Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)
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Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))
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Machines and rooms properly identified?<br>21 CFR 111.365(k)
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In process product is covered and labeled?<br>21 CFR 111.460(k)
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Only one product in a room at a time?<br>21 CFR 111.460(a)
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Scales have a current calibration sticker?<br>21 CFR 111.30(c)
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Daily Scale Check is documented and up to date?
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Paperwork properly documented?<br>21 CFR 111.260(j)
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Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))
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Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))
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Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)
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Other GMP issues?
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Misc. Pictures
Hard Shell Capsule Polish / Inspect Department
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Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))
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Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)
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Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))
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Machines and rooms properly identified?<br>21 CFR 111.365(k)
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In process product is covered and labeled?<br>21 CFR 111.460(k)
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Only one product in a room at a time?<br>21 CFR 111.460(a)
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Scales have a current calibration sticker?<br>21 CFR 111.30(c)
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Daily Scale Check is documented and up to date?
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Paperwork properly documented?<br>21 CFR 111.260(j)
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Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))
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Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))
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Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)
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Other GMP issues?
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Misc. Pictures
Packaging Department
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Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))
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Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)
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Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))
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Machines and rooms properly identified?<br>21 CFR 111.365(k)
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In process product is covered and labeled?<br>21 CFR 111.460(k)
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Only one product in a room at a time?<br>21 CFR 111.460(a)
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Scales have a current calibration sticker?<br>21 CFR 111.30(c)
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Daily Scale Check is documented and up to date?
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Paperwork properly documented?<br>21 CFR 111.260(j)
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Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))
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Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))
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No tools or rags on machines?
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No tape or cardboard or other unapproved materials used on packaging lines?<br>21 CFR 111.25(c)
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Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)
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Other GMP issues?
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Misc. Pictures
Powder Filling Department
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Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))
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Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)
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Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))
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Machines and rooms properly identified?<br>21 CFR 111.365(k)
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In process product is covered and labeled?<br>21 CFR 111.460(k)
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Only one product in a room at a time?<br>21 CFR 111.460(a)
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Paperwork properly documented?<br>21 CFR 111.260(j)
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Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))
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Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))
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No tools or rags in machines?
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No tape or cardboard or other unapproved materials used on packaging lines?<br>21 CFR 111.25(c)
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Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)
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Other GMP issues?
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Misc. Pictures
General
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General use areas are clean and free from debris?
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Unused equipment is properly covered and stored?
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Washroom is kept clean and organized?
Maintenance Department
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Maintenance records for all equipment?
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Does the company have equipment maintenance records?
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Are the maintenance records are up to date?
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Maintenance tools, supplies, and lubricants/liquids are properly stored and approved for use?<br>21 CFR 111.15(c)
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Other GMP issues?
Quality Control Laboratory
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Instrument logs are up to date and complete?<br>21 CFR 111.35(b(2, 3))
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Calibration stickers on all pertinent equipment?<br>21 CFR 111.35(b(3))
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Lab notebooks up to date and complete?
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Scales calibrated and checked daily?<br>21 CFR 111.35(b(3))
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Employees wearing lab coats?
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Lab kept clean and organized?
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Sinks and area clean?
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Other GMP issues?
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Misc. Pictures
Quality Assurance
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Retain samples are kept and stored properly?<br>21 CFR 111.465
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Retention room up to date and clean?
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Scale calibration system documented?<br>21 CFR 111.35(b(3))
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Pest control system documented?<br>21 CFR 111.23(b)
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Enforcement of employees not wearing earrings, jewelry, fake nails?<br>21 CFR 111.10(b(4))
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Enforcement of employees wear gloves and hairnets at all times?<br>21 CFR 111.10(b(6))
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Quality assurance personnel have outlined duties (SOPs) to direct them in enforcing GMPs and SOPs?<br>21 CFR 111.103
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Vendor qualifications are properly documented?<br>21 CFR 111.75(a(2(ii(A-E))))
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Investigations are performed as required by GMPs?<br>21 CFR 111.135, 140, 530
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Investigations are complete and review all possible causes?
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Investigations show final dispositions and/or corrections and precautions to prevent repeated problems?
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Other GMP issues?
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Misc. pictures
Documentation
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Manufacturing records are retrieved in an acceptable time?
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Manufacturing records are complete with no errors?
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Packaging records are included?
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Test records for in-process, final bulk, and final packaged product are included?
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Distribution records are included?
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Raw material records are retrieved in an acceptable time?
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Raw material records are complete with no errors?
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Test records are included?
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Certificate of analysis is included?
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Distribution records (control cards) are included for lots that have been depleted?
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Master files meet all GMP requirements?<br>21 CFR 111.210
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Training records are up to date?<br>21 CFR 111.14(b(2))
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Training records for each employee?
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GMP training is included and is repeated?
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SOP training is included as they apply to employee?
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Other GMP issues?
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Misc. pictures
Final
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Misc. Notes
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Qualification standards can be measured by a point system or a percentage system. Companies may decide to use either or possibly both for final evaluation. For the purposes of this audit, a percentage is given. Generally, the qualification standard by percentage is determined by the client requesting the audit. ISPEph requires a score of 90 percent for compliance qualification, however certain situations may be taken into account such as the severity of the findings or violation. In such cases, ISPEph requires a score of no less than 85 percent.
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Signature of Auditor
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Signature of Company Representative