Warehouse #2

  • Lot clean and free of debris

  • Free of weeds and other plants

  • No standing water on premises

  • Gate closed when not in use

  • Pest control traps in place and up to date

  • Storage containers closed

  • Doors closed when not in use

  • Packaging quarantine area clean and free of debris

  • Packaging quarantine area chain on when not in use

  • Inside of warehouse is clean and orderly

  • Raw materials stored neatly

  • No spills or broken shrink and/or pallets

  • Raw materials have qc released stickers

  • Raws are sealed and undamaged

  • All floor pallets are a minimum of 12" away from walls

  • Only in-process pallets in the designated area

  • Pallets are identified correctly

  • Pallets are stored neat and orderly

  • Hallways clean

  • Parts sink clean

  • Restroom clean and sanitized

  • Break room clean

Receiving Department

  • Quarantine area locked

  • Quarantine area clean & organized

  • Logs are complete and up to date

  • Paperwork standards

Quality Control Laboratory

  • Lab kept clean and up to date

  • Employees wearing hairnets and labcoats

  • Paperwork standards

  • Logs are up to date and complete

  • Lab notebooks up to date and complete

  • Calibration stickers on all pertinent equipment

  • Scales calibrated and checked daily

Weighing Department

  • Room is clean

  • Floors/walls are clean and undamaged

  • Lights are clean and undamaged

  • Scales are calibrated

  • Workstations kept clean

  • Materials are covered and stored properly

  • Dust collector on while working in room

  • Raws are returned and stored properly to warehouse

  • Paperwork standards

Tablet Department

  • Room is clean

  • Floor/walls are clean and undamaged

  • Tablet press is properly identified

  • In process product is covered and labeled

  • Grinder is properly stored and identified

  • Lights are clean, undamaged and have tube guards

  • Scales are calibrated

  • Tablet paperwork standards

  • Grinder paperwork standards

  • Extra parts/machinery covered and tagged

Warehouse #1

  • Lot is clean and free of debris

  • Lot is free of weeds and other plants

  • No standing water on premises

  • Back gate 1/2 closed

  • Black side door closed

  • Pallets properly labeled and shrunk

  • Clean buckets drying off the floor

  • Finished pallets release and shrunk

  • Lids/buckets stored neatly

  • Door closed when not in use

  • Emergency door accesible

  • Warehouse clean and free of debris

  • Stored items faced and neat

  • All pallets identified with proper tags

  • Empty powder drums stored and labeled

  • Capsule boxes closed and faced

  • Tube guards on lights and all lights working properly

  • Staged items identified

  • In process capsules labeled and stored

  • In process buckets sealed with pink zip ties

  • Pallets clean and free of debris

  • Forklift log up to date

  • Delivery truck log up to date

  • Component cards up to date

  • Paperwork standards

  • Pest control traps in place and up to date

  • Scales calibrated

Encapsulation Department Room #1

  • Machines and room identified

  • Room clean

  • Floor/walls clean and undamaged

  • Paperwork standards

  • Employees properly gowned / hairnets

  • Only one product in a room at a time

  • Vibrators on while machine is running

  • Scales calibrated

  • Tube guards on

Encapsulation Department Room #2

  • Machines and room identified

  • Floor/walls clean and undamaged

  • Paperwork standards

  • Employees properly gowned and hairnets

  • Only one product in a room at a time

  • Vibrators on while machine is running

  • Scales calibrated

  • Tube guards on

Encapsulation Department Room #3

  • Floor/walls clean and undamaged

  • Paperwork standards

  • Employees properly gowned and hairnets

  • Only one product in a room at a time

  • Vibrators on while machine is running

  • Scales calibrated

  • Tube guards on

Encapsulation Department Room #4

  • Floor/Walls clean and undamaged

  • Paperwork standards

  • Employees properly gowned and hairnets

  • Only one product in a room at a time

  • Vibrators on while machine is running

  • Scales calibrated

  • Tube guards on

Encapsulation Department Room #5

  • Floor/walls clean and undamaged

  • Paperwork standards

  • Employees properly gowned and hairnets

  • Only one product in a room at a time

  • Vibrators on while machine is running

  • Scale calibrated

  • Tube guards on

Polish / Inspect Department

  • Room is clean

  • Floor/walls clean and undamaged

  • Machines properly identified

  • Only one product running at a time

  • Unused machinery properly identified and covered

  • Paperwork standards

  • Product off floor

  • Product sealed and identified

  • Employees properly gowned and hairnets used

  • Dust collector on while working

  • Tube guards on

Blending Department - V Blender Room

  • Room is clean

  • Floor/walls clean and undamaged

  • Machines properly identified

  • Scale calibrated

  • Paperwork standards

  • Employees properly gowned and hairnets

  • Tube guards

Blending Department - Ribbon Blender Room

  • Room is clean

  • Floor/walls clean and undamaged

  • Machines properly identified

  • Scales calibrated

  • Paperwork standards

  • Employees properly gowned and hairnets

  • Tube guards

Packaging Department

  • Room is clean

  • Floor/walls are clean and undamaged

  • Machines properly identified

  • Line properly identified

  • Only one product running at a time

  • Quality checks performed

  • Paperwork completed with initials

  • Pallet properly counted and tagged

  • Employees properly gowned and hairnets

  • No tools or rags in machines

  • Tube guards on

Powder Department

  • Room is clean

  • Floor/walls clean and undamaged

  • Machines properly identified

  • Only one product running at a time

  • Paperwork standards

  • Quality checks performed

  • Paperwork completed with initials

  • Employees properly gowned and hairnets

  • No tools or rags on machines

  • Scales calibrated

  • Unused machinery covered and identified

  • Tube guards

Maintenance Department

  • Red maintenance books up to date and complete

  • PMI's performed on all machinery

  • Proper lubricants used on machinery

Cleaning Department

  • Day cleaning duties performed

  • Night cleaning duties performed

Quality Unit

  • Sinks and area clean

  • Restrooms clean and sanitized

  • General cleaning of facility and production. Check wall and door sills.

  • Cleaning duties and crew reviewed

  • Scale calibration system updated

  • Retention room up to date and clean

  • Pest control system up to date

  • Fire extinguishers up to date

  • In process controls

  • Test records and releases

  • Employees not wearing earrings, jewelry, fake nails

  • Employees wear gloves and hairnets at all times

  • Random sop quizzing of employees

  • Sop question asked to employee. Please include question and employee name.

  • Sop question asked to employee. Please include question and employee name.

  • Sop question asked to employee. Please include question and employee name.

  • Training records reviewed

  • Random ATP testing performed

  • Verify certificate of analysis validations

Final

  • Misc. Notes

  • Misc. Picture

  • Misc. Picture

  • Misc. Picture

  • Signature of Auditor

  • Reviewed By

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