Information

  • Audit Title

  • Document No.

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

Facility and Grounds

  • Anti-siphon devices on water outlets?

  • Shrubs are spaced away from outer walls?<br>21 CFR 110.20 (a)(1)

  • Rubbish is contained and grounds are clean? 21 CFR 110 (a)(1)

  • Entries into the facility are designed to prevent pest from entering the facility?<br>

  • Restrooms clean and sanitized?

  • Company has and follows SOPs for cleaning and maintenance of the facility and grounds?

  • Other GMP issues?

  • Misc. Pictures

Receiving Department

  • Quarantine area controlled or locked?

  • Quarantine area clean & organized?

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

  • Receiving log is documented correctly and up to date?

  • Raw Material Check-in Log is documented correctly and up to date?

  • Company has and follows SOPs for receiving and quarantine?

  • Other GMP issues?

  • Misc. Pictures

Warehouse

  • Doors leading to outside are closed?

  • All materials are stored up off the floor?

  • All raw materials bear a release sticker?

  • All containers are properly closed?

  • Warehouse floor is clean and free of debris?

  • ID tags are visible from isles?

  • All pallets identified with proper tags?

  • Empty containers have labels removed or defaced?

  • Trash receptacles are clearly marked and emptied when full?

  • Tube guards on lights and all lights working properly?

  • In process materials are clearly labeled?

  • Empty pallets are properly and neatly stored?

  • Pest control devices are not damaged and traps in place?

  • Pallet racks are mounted away from walls to allow for cleaning between walls and racks?

  • Tops of all containers are free from debris and residual dust?

  • Other GMP issues?

  • Misc. Pictures

Weighing/Subdividing Department

  • Floors/walls clean and undamaged?

  • Lights are clean, undamaged and have tube guards?

  • Room(s) are large enough for the operation of weighing materials?

  • Employees properly gowned and hairnets?

  • In process product is covered and labeled?

  • Only one product in a room at a time?

  • Scales have a current calibration sticker?

  • Daily Scale Check is documented and up to date?

  • Paperwork for processed materials is properly documented?

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

  • Dust collector is adequate and working?

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

  • Other GMP issues?

  • Misc. Pictures

Blending/Compounding/Processing Department

  • Floor/walls clean and undamaged?

  • Lights are clean, undamaged and have tube guards?

  • Room(s) are of suitable size and design for the blending operation?

  • Employees properly gowned and hairnets?

  • Machines and rooms properly identified?

  • In process product is covered and labeled?

  • Only one product in a room/area at a time?

  • Scales have a current calibration sticker?

  • Daily Scale Check is documented and up to date?

  • Paperwork properly documented?

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

  • Dust collector is adequate and working?

  • Trash receptacles are clearly marked and emptied when full?

  • 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 tools, supplies, and lubricants/liquids are properly stored and approved for use?

  • Does the company have equipment maintenance records?

  • Are the maintenance records are up to date?

  • Other GMP issues?

Quality Control Laboratory

  • Instrument logs are up to date and complete?

  • Current calibration or certification stickers on all analytical equipment?

  • Lab notebooks up to date and complete?

  • Scales calibrated and checked daily?

  • 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?

  • Retention room up to date and clean?

  • Scale calibration system documented?

  • Pest control system documented?

  • Enforcement of employees not wearing earrings, jewelry, fake nails?

  • Enforcement of employees wear gloves and hairnets at all times?

  • Quality assurance personnel have outlined duties (SOPs) to direct them in enforcing GMPs and SOPs?

  • Vendor qualifications are properly documented?

  • Company has a written HACCP program.

  • Company has an SOP regarding customer complaints?

  • Investigations are performed as required by GMPs?

  • 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/Compounding records are retrieved in an acceptable time?

  • Manufacturing/Compounding records are complete with no errors?

  • Packaging records or instructions are included showing documentation?

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

  • Distribution records for all finished compounded materials 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 for processed materials meet all GMP requirements?

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

  • Training records are up to date?

  • 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

  • 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

  • Signature of Company Representative

Disclaimer

The templates available in our Public Library have been created by our customers and employees to help get you started using SafetyCulture's solutions. The templates are intended to be used as hypothetical examples only and should not be used as a substitute for professional advice. You should seek your own professional advice to determine if the use of a template is permissible in your workplace or jurisdiction. You should independently determine whether the template is suitable for your circumstances.