Information

  • Audit Title

  • Document No.

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

Facility and Grounds

  • Anti-siphon devices on water outlets?<br>21 CFR 111.15(f(5))

  • Shrubs are spaced away from outer walls?<br>21 CFR 111.15(a(1))

  • Rubbish is contained and grounds are clean?<br>21 CFR 111.15(a(1))

  • Entries into the facility are designed to prevent pest from entering the facility?<br>21 CFR 111.15(d(2))

  • Restrooms clean and sanitized?<br>21 CFR 111.15(h)

  • Company has and follows SOPs for cleaning and maintenance of the facility and grounds?<br>21 CFR 111.16

  • Other GMP issues?

  • Misc. Pictures

Receiving Department

  • 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

  • Quarantine area clean & organized?<br>21 CFR 111.15(b(1))

  • Company has an acceptable area or room for taking samples?

  • Receiving log is documented correctly and up to date?<br>21 CFR 111.180(b(2))

  • Raw Material Check-in Log is documented correctly and up to date?<br>21 CFR 111.180(b(2))

  • Packaging Material Check-in Log is documented correctly and up to date?<br>21 CFR 111.180(b(2))

  • Label Check-in Log is documented correctly and up to date?<br>21 CFR 111.180(b(2))

  • Finished Product Check-in Log is documented correctly and up to date?<br>21 CFR 111.180(b(2))

  • Company has and follows SOPs for receiving and quarantine?<br>21 CFR 111.153

  • Other GMP issues?

  • Misc. Pictures

Warehouse

  • Doors leading to outside are closed?<br>21 CFR 111.15(d(2))

  • All materials are stored up off the floor?<br>21 CFR 111.365(f)

  • All components bear a release sticker?<br>21 CFR 111.155(c(3))

  • All containers are properly closed?<br>21 CFR 111.365(f)

  • Warehouse floor is clean and free of debris?<br>21 CFR 111.15(b(1))

  • ID tags are visible from isles?<br>21 CFR 111.20(c(1))

  • All pallets identified with proper tags?<br>21 CFR 111.20(c(1))

  • Empty containers have labels removed or defaced?

  • Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)

  • Tube guards on lights and all lights working properly?<br>21 CFR 111.20(f)

  • In process materials are clearly labeled?<br>21 CFR 111.20(c(1))

  • Empty pallets are properly and neatly stored?

  • Pest control devices are not damaged and traps in place?<br>21 CFR 111.15(d(2))

  • Scales, if applicable, have a current calibration sticker?<br>21 CFR 111.30(c)

  • Pallet racks are mounted away from walls to allow for cleaning between walls and racks?<br>21 CFR 111.20(b)

  • Tops of all containers are free from debris and residual dust?<br>21 CFR 111.15(b(1))

  • Other GMP issues?

  • Misc. Pictures

Weighing Department

  • Floors/walls clean and undamaged?<br>21 CFR 111.15(b(1)), 111.15(b(2))

  • Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)

  • Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))

  • In process product is covered and labeled?<br>21 CFR 111.460(a)

  • Only one product in a room at a time?<br>21 CFR 111.460(a)

  • Scales have a current calibration sticker?<br>21 CFR 111.30(c)

  • Daily Scale Check is documented and up to date?<br>21 CFR 111.30(c)

  • Paperwork properly documented?<br>21 CFR 111.260(j)

  • Room Cleaning and Use Records are up to date and completed correctly?

  • Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))

  • Component Control Cards up to date?

  • Other GMP issues?

  • Misc. Pictures

Blending/Compounding Department

  • Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))

  • Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)

  • Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))

  • Machines and rooms properly identified?<br>21 CFR 111.365(k)

  • In process product is covered and labeled?<br>21 CFR 111.460(k)

  • Only one product in a room/area at a time?<br>21 CFR 111.460(a)

  • Scales have a current calibration sticker?<br>21 CFR 111.30(c)

  • Daily Scale Check is documented and up to date?

  • Paperwork properly documented?<br>21 CFR 111.260(j)

  • Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))

  • Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))

  • Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)

  • Other GMP issues?

  • Misc. Pictures

Tablet Department

  • Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))

  • Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)

  • Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))

  • Machines and rooms properly identified?<br>21 CFR 111.365(k)

  • In process product is covered and labeled?<br>21 CFR 111.460(k)

  • Only one product in a room at a time?<br>21 CFR 111.460(a)

  • Scales have a current calibration sticker?<br>21 CFR 111.30(c)

  • Daily Scale Check is documented and up to date?

  • Paperwork properly documented?<br>21 CFR 111.260(j)

  • Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))

  • Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))

  • Extra parts/machinery covered and tagged?<br>21 CFR 111.27(d)

  • Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)

  • Other GMP issues?

  • Misc. Pictures

Encapsulation Department

  • Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))

  • Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)

  • Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))

  • Machines and rooms properly identified?<br>21 CFR 111.365(k)

  • In process product is covered and labeled?<br>21 CFR 111.460(k)

  • Only one product in a room at a time?<br>21 CFR 111.460(a)

  • Scales have a current calibration sticker?<br>21 CFR 111.30(c)

  • Daily Scale Check is documented and up to date?

  • Paperwork properly documented?<br>21 CFR 111.260(j)

  • Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))

  • Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))

  • Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)

  • Other GMP issues?

  • Misc. Pictures

Polish / Inspect Department

  • Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))

  • Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)

  • Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))

  • Machines and rooms properly identified?<br>21 CFR 111.365(k)

  • In process product is covered and labeled?<br>21 CFR 111.460(k)

  • Only one product in a room at a time?<br>21 CFR 111.460(a)

  • Scales have a current calibration sticker?<br>21 CFR 111.30(c)

  • Daily Scale Check is documented and up to date?

  • Paperwork properly documented?<br>21 CFR 111.260(j)

  • Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))

  • Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))

  • Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)

  • Other GMP issues?

  • Misc. Pictures

Packaging Department

  • Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))

  • Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)

  • Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))

  • Machines and rooms properly identified?<br>21 CFR 111.365(k)

  • In process product is covered and labeled?<br>21 CFR 111.460(k)

  • Only one product in a room at a time?<br>21 CFR 111.460(a)

  • Scales have a current calibration sticker?<br>21 CFR 111.30(c)

  • Daily Scale Check is documented and up to date?

  • Paperwork properly documented?<br>21 CFR 111.260(j)

  • Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))

  • Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))

  • No tools or rags on machines?

  • No tape or cardboard or other unapproved materials used on packaging lines?<br>21 CFR 111.25(c)

  • Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)

  • Other GMP issues?

  • Misc. Pictures

Powder Filling Department

  • Floor/walls clean and undamaged?<br>21 CFR 111.20(d(1(I)))

  • Lights are clean, undamaged and have tube guards?<br>21 CFR 111.20(f)

  • Employees properly gowned and hairnets?<br>21 CFR 111.10(b(6))

  • Machines and rooms properly identified?<br>21 CFR 111.365(k)

  • In process product is covered and labeled?<br>21 CFR 111.460(k)

  • Only one product in a room at a time?<br>21 CFR 111.460(a)

  • Paperwork properly documented?<br>21 CFR 111.260(j)

  • Equipment and Room Cleaning and Use Records are up to date and completed correctly?<br>21 CFR 111.35(b(2))

  • Dust collector is adequate and working?<br>21 CFR 111.20(d(1(iii)))

  • No tools or rags in machines?

  • No tape or cardboard or other unapproved materials used on packaging lines?<br>21 CFR 111.25(c)

  • Trash receptacles are clearly marked and emptied when full?<br>21 CFR 111.15(j)

  • Other GMP issues?

  • Misc. Pictures

General

  • General use areas are clean and free from debris?

  • Unused equipment is properly covered and stored?

  • Washroom is kept clean and organized?

Maintenance Department

  • Maintenance records for all equipment?

  • Does the company have equipment maintenance records?

  • Are the maintenance records are up to date?

  • Maintenance tools, supplies, and lubricants/liquids are properly stored and approved for use?<br>21 CFR 111.15(c)

  • Other GMP issues?

Quality Control Laboratory

  • Instrument logs are up to date and complete?<br>21 CFR 111.35(b(2, 3))

  • Calibration stickers on all pertinent equipment?<br>21 CFR 111.35(b(3))

  • Lab notebooks up to date and complete?

  • Scales calibrated and checked daily?<br>21 CFR 111.35(b(3))

  • Employees wearing lab coats?

  • Lab kept clean and organized?

  • Sinks and area clean?

  • Other GMP issues?

  • Misc. Pictures

Quality Assurance

  • Retain samples are kept and stored properly?<br>21 CFR 111.465

  • Retention room up to date and clean?

  • Scale calibration system documented?<br>21 CFR 111.35(b(3))

  • Pest control system documented?<br>21 CFR 111.23(b)

  • Enforcement of employees not wearing earrings, jewelry, fake nails?<br>21 CFR 111.10(b(4))

  • Enforcement of employees wear gloves and hairnets at all times?<br>21 CFR 111.10(b(6))

  • Quality assurance personnel have outlined duties (SOPs) to direct them in enforcing GMPs and SOPs?<br>21 CFR 111.103

  • Vendor qualifications are properly documented?<br>21 CFR 111.75(a(2(ii(A-E))))

  • Investigations are performed as required by GMPs?<br>21 CFR 111.135, 140, 530

  • Investigations are complete and review all possible causes?

  • Investigations show final dispositions and/or corrections and precautions to prevent repeated problems?

  • Other GMP issues?

  • Misc. pictures

Documentation

  • Manufacturing records are retrieved in an acceptable time?

  • Manufacturing records are complete with no errors?

  • Packaging records are included?

  • Test records for in-process, final bulk, and final packaged product are included?

  • Distribution records are included?

  • Raw material records are retrieved in an acceptable time?

  • Raw material records are complete with no errors?

  • Test records are included?

  • Certificate of analysis is included?

  • Distribution records (control cards) are included for lots that have been depleted?

  • Master files meet all GMP requirements?<br>21 CFR 111.210

  • Training records are up to date?<br>21 CFR 111.14(b(2))

  • Training records for each employee?

  • GMP training is included and is repeated?

  • SOP training is included as they apply to employee?

  • Other GMP issues?

  • Misc. pictures

Final

  • Misc. Notes

  • Misc. Pictures

  • Signature of Auditor

  • Signature of Company Representative

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