GMP/SOP Audit - RM Supplier

• Audit Title

• Document No.

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

Facility and Grounds

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Other GMP issues?

  Safe

  At Risk

  N/A

• Misc. Pictures

  Media

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Other GMP issues?

  Safe

  At Risk

  N/A

• Misc. Pictures

  Media

Warehouse

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Empty containers have labels removed or defaced?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Empty pallets are properly and neatly stored?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Other GMP issues?

  Safe

  At Risk

  N/A

• Misc. Pictures

  Media

Weighing/Subdividing Department

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Paperwork for processed materials is properly documented?<br>21 CFR 111.260(j)

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Component Control Cards or distribution records reflect distribution by lot and are up to date?

  Yes

  No

  N/A

• Other GMP issues?

  Safe

  At Risk

  N/A

• Misc. Pictures

  Media

Blending/Compounding/Processing Department

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Daily Scale Check is documented and up to date?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Other GMP issues?

  Safe

  At Risk

  N/A

• Misc. Pictures

  Media

Bulk Packaging Department

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Daily Scale Check is documented and up to date?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• No tools or rags on machines?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Other GMP issues?

  Safe

  At Risk

  N/A

• Misc. Pictures

  Media

General

• General use areas are clean and free from debris?

  Yes

  No

  N/A

• Unused equipment is properly covered and stored?

  Yes

  No

  N/A

• Washroom is kept clean and organized?

  Yes

  No

  N/A

Maintenance Department

• Does the company have equipment maintenance records?

  Yes

  No

  N/A

• Are the maintenance records are up to date?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Other GMP issues?

  Safe

  At Risk

  N/A

Quality Control Laboratory

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

  Yes

  No

  N/A

• Current calibration or certification stickers on all analytical equipment?<br>21 CFR 111.35(b(3))

  Yes

  No

  N/A

• Lab notebooks up to date and complete?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Employees wearing lab coats?

  Yes

  No

  N/A

• Lab kept clean and organized?

  Yes

  No

  N/A

• Sinks and area clean?

  Yes

  No

  N/A

• Other GMP issues?

  Safe

  At Risk

  N/A

• Misc. Pictures

  Media

Quality Assurance

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

  Yes

  No

  N/A

• Retention room up to date and clean?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Company has a written HACCP program.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Investigations are complete and review all possible causes?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Other GMP issues?

  Safe

  At Risk

  N/A

• Misc. pictures

  Media

Documentation

• Manufacturing/Compounding records are retrieved in an acceptable time?

  Yes

  No

  N/A

• Manufacturing/Compounding records are complete with no errors?

  Yes

  No

  N/A

• Packaging records or instructions are included showing documentation?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Distribution records for all finished compounded materials are included?

  Yes

  No

  N/A

• Raw material records are retrieved in an acceptable time?

  Yes

  No

  N/A

• Raw material records are complete with no errors?

  Yes

  No

  N/A

• Test records are included?

  Yes

  No

  N/A

• Certificate of analysis is included?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Master Specification/Test Records for each processed material and for each raw material meet GMP requirements?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Training records for each employee?

  Yes

  No

  N/A

• GMP training is included and is repeated?

  Yes

  No

  N/A

• SOP training is included as they apply to employee?

  Yes

  No

  N/A

• Other GMP issues?

  Safe

  At Risk

  N/A

• Misc. pictures

  Media

Final

• Misc. Notes

• 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.

• Signature of Auditor

  Sign

• Signature of Company Representative

  Sign