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-syphon devices on water outlets? 21 CFR 111.15(f(5))
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Shrubs are spaced away from outer walls? 21 CFR 111.15(a(1))
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Rubbish is contained and grounds are clean? 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 for taking samples?
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Receiving log is documented correctly and up to date? 21 CFR 111.180(b(2))
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Raw Material Check-in Log is documented correctly and up to date? 21 CFR 111.180(b(2))
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Packaging Material Check-in Log is documented correctly and up to date? 21 CFR 111.180(b(2))
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Label Check-in Log is documented correctly and up to date? 21 CFR 111.180(b(2))
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Finished Product Check-in Log is documented correctly and up to date? 21 CFR 111.180(b(2))
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Company has and follows SOPs for receiving and quarantine? 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? 21 CFR 111.15(d(2))
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All materials are stored up off the floor? 21 CFR 111.365(f)
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All components bear a release sticker? 21 CFR 111.155(c(3))
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All containers are properly closed? 21 CFR 111.365(f)
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Warehouse floor is clean and free of debris? 21 CFR 111.15(b(1)).
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ID tags are visible from isles? 21 CFR 111.20(c(1))
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All pallets identified with proper tags? 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? 21 CFR 111.15(j)
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Tube guards on lights and all lights working properly? 21 CFR 111.20(f)
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In-process materials are clearly labeled? 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 are in place? 21 CFR 111.15(d(2))
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Scales, if applicable, have current calibration stickers? 21 CFR 111.30(c)
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Pallet racks are mounted away from walls to allow for cleaning between walls and racks? 21 CFR 111.20(b)
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Tops of all containers are free from debris and residual dust? 21 CFR 111.15(b(1))
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Other GMP issues?
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Miscellaneous Pictures
Weighing Department
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Floors/walls clean and undamaged? 21 CFR 111.15(b(1)), 111.15(b(2))
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Lights are clean, undamaged and have tub guards? 21 CFR 111.20(f)
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Employees properly gowned and wearing hair covering? 21 CFR 111.10(b(6))
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In-process product is covered and labeled? 21 CFR 111.460(a)
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Only one product in a room at a time? 21 CFR 111.460(a)
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Scales have current calibration stickers? 21 CFR 111.30(c)
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Daily Scale Check is documented and up to date? 21 CFR 111.30(c)
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Paperwork is properly documented? 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? 21 CFR 111.20(d(1(iii)))
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Trash receptacles are clearly marked and emptied when full? 21 CFR 111.15(j)
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Component Control Cards are being used and are up to date?
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Other GMP issues?
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Misc. Pictures
Softgel Encapsulation Department
Softgel Blending Area
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Floor/walls clean and undamaged? 21 CFR 111.20(d(1(l)))
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Lights are clean, undamaged and have tub guards? 21 CFR 111.20(f)
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Employees properly gowned and wearing hair covering? 21 CFR 111.10(b(6))
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Machines and rooms properly identified? 21 CFR 111.365(k)
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Only one product in a room at a time? 21 CFR 111.460(a)
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In-process product is covered and labeled? 21 CFR 111.460(a)
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Scales have current calibration stickers? 21 CFR 111.30(c)
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Daily Scale Check is documented and up to date? 21 CFR 111.30(c)
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Paperwork is properly documented? 21 CFR 111.260(j)
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Equipment and Room Cleaning and Use Records are up to date and completed correctly? 21 CFR 111.35(b(2))
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Dust collector is adequate and working? 21 CFR 111.20(d(1(iii)))
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Trash receptacles are clearly marked and emptied when full? 21 CFR 111.15(j)
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Other GMP issues?
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Misc. Pictures
Softgel Encapsulation Area
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Floor/walls clean and undamaged? 21 CFR 111.20(d(1(l)))
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Lights are clean, undamaged and have tub guards? 21 CFR 111.20(f)
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Employees properly gowned and wearing hair covering? 21 CFR 111.10(b(6))
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Machines and rooms properly identified? 21 CFR 111.365(k)
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Only one product in a room at a time? 21 CFR 111.460(a)
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In-process product is covered and labeled? 21 CFR 111.460(a)
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Scales have current calibration stickers? 21 CFR 111.30(c)
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Daily Scale Check is documented and up to date? 21 CFR 111.30(c)
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Paperwork is properly documented? 21 CFR 111.260(j)
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Equipment and Room Cleaning and Use Records are up to date and completed correctly? 21 CFR 111.35(b(2))
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Dust collector is adequate and working? 21 CFR 111.20(d(1(iii))
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Trash receptacles are clearly marked and emptied when full? 21 CFR 111.15(j)
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Other GMP issues?
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Misc. Pictures
Softgel Capsule Polish / Inspection Department
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Floor/walls clean and undamaged? 21 CFR 111.20(d(1(l)))
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Lights are clean, undamaged and have tub guards? 21 CFR 111.20(f)
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Employees properly gowned and wearing hair covering? 21 CFR 111.10(b(6))
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Machines and rooms properly identified? 21 CFR 111.365(k)
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Only one product in a room at a time? 21 CFR 111.460(a)
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In-process product is covered and labeled? 21 CFR 111.460(a)
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Only one product in a room at a time? 21 CFR 111.460(a)
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Scales have current calibration stickers? 21 CFR 111.30(c)
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Daily Scale Check is documented and up to date? 21 CFR 111.30(c)
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Equipment and Room Cleaning and Use Records are up to date and completed correctly? 21 CFR 111.35(b(2))
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Trash receptacles are clearly marked and emptied when full? 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? 21 CFR 111.20(d(1(l)))
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Lights are clean, undamaged and have tub guards? 21 CFR 111.20(f)
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Employees properly gowned and wearing hair covering? 21 CFR 111.10(b(6))
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Machines and rooms properly identified? 21 CFR 111.365(k)
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In-process product is covered and labeled? 21 CFR 111.460(a)
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Only one product in a room at a time? 21 CFR 111.460(a)
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Scales have current calibration stickers? 21 CFR 111.30(c)
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Daily Scale Check is documented and up to date? 21 CFR 111.30(c)
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Paperwork is properly documented?
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Equipment and Room Cleaning and Use Records are up to date and completed correctly? 21 CFR 111.35(b(2))
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Air handler system is working properly? 21 CFR 111.20(d(1(iii))
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No tools or rags on the machines?
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No tape or cardboard or other unapproved materials used on packaging lines? 21 CFR 111.25(c)
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Trash receptacles are clearly marked and emptied when full? 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 company have maintenance records for all equipment?
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Are the maintenance records up to date?
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Maintenance tools, supplies, and lubricants/liquids are properly stored and approved for use? 21 CFR 111.15(c)
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. GMP Consulting Services 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, GMP Consulting Services requires a score of no less than 85 percent.
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Signature of Auditor
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Signature of Company Representative
Disclaimer
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Disclaimer:
The assessors believe the information contained within this risk assessment report to be correct at the time of printing. The assessors do not accept responsibility for any consequences arising from the use of the information herein. This report is based on matters which were observed or came to the attention of the assessors during the day of the assessment and should not be relied upon as an exhaustive record of all possible risks or compliance issues that may exist or potential improvements that can be made. Although Raw Material Suppliers are not regulated by 21 CFR 111, this audit may include such regulations as they might apply in control procedures for any operation
handling food or other ingredients that may be consumed by the public. Information on the latest FDA regulations can be found at www.fda.gov. For specific information regarding Good Manufacturing Practices for drugs or dietary supplements, enter 21 CFR 210, 21 CFR 111, or 21 CFR 110 in the search window of the FDA's home page. You can also go to our website at www.comply2000.com and click on the FDA website at the bottom of our Services page.
Confidentiality Statement:
In order to maintain the integrity and credibility of the risk assessment processes and to protected the parties involved, it is understood that the assessors will not divulge to unauthorized persons any information obtained during this risk assessment unless legally obligated to do so.
