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-siphon devices on water outlets?<br>
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Rubbish is contained and grounds are clean?<br>
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Entries into the facility are designed to prevent pest from entering the facility?<br>
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Restrooms clean and sanitized?
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Company has and follows SOPs for cleaning and maintenance of the facility and grounds?
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Other GMP issues?
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Misc. Pictures
Receiving Department
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Quarantine area controlled or locked?
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Quarantine area clean & organized?
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Company has an acceptable area or room for taking samples?
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Receiving log is documented correctly and up to date?
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Raw Material Check-in Log is documented correctly and up to date?
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Packaging Material Check-in Log is documented correctly and up to date?
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Label Check-in Log is documented correctly and up to date?
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Finished Product Check-in Log is documented correctly and up to date?
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Company has and follows SOPs for receiving and quarantine?
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Other GMP issues?
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Misc. Pictures
Warehouse
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Doors leading to outside are closed?
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All materials are stored up off the floor?
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All components bear a release sticker?
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All containers are properly closed?
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Warehouse floor is clean and free of debris?
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ID tags are visible from isles?
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All pallets identified with proper tags?
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Empty containers have labels removed or defaced?
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Trash receptacles are clearly marked and emptied when full?
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Tube guards on lights and all lights working properly?
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In process materials are clearly labeled?
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Empty pallets are properly and neatly stored?
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Pest control devices are not damaged and traps in place?
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Scales, if applicable, have a current calibration sticker?
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Pallet racks are mounted away from walls to allow for cleaning between walls and racks?
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Tops of all containers are free from debris and residual dust?
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Other GMP issues?
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Misc. Pictures
Pre-Weigh Department
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Floors/walls clean and undamaged?
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Lights are clean, undamaged and have tube guards?
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Employees properly gowned and hairnets?
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In process product is covered and labeled?
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Only one product in a room at a time?
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Scales have a current calibration sticker?
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Daily Scale Check is documented and up to date?
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Paperwork properly documented?
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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?
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Component Control Cards up to date?
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Other GMP issues?
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Misc. Pictures
Compounding Department
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Floor/walls clean and undamaged?
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Lights are clean, undamaged and have tube guards?
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Employees properly gowned and hairnets?
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Machines and rooms properly identified?
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In process product is covered and labeled?
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Only one product in a room/area at a time?
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Scales have a current calibration sticker?
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Daily Scale Check is documented and up to date?
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Paperwork properly documented?
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Equipment and Room Cleaning and Use Records are up to date and completed correctly?
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Dust collector is adequate and working?
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Trash receptacles are clearly marked and emptied when full?
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Other GMP issues?
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Misc. Pictures
Packaging Department
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Floor/walls clean and undamaged?
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Lights are clean, undamaged and have tube guards?
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Employees properly gowned and hairnets?
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Machines and rooms properly identified?
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In process product is covered and labeled?
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Only one product in a room at a time?
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Scales have a current calibration sticker?
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Daily Scale Check is documented and up to date?
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Paperwork properly documented?
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Equipment and Room Cleaning and Use Records are up to date and completed correctly?
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Dust collector is adequate and working?
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No tools or rags on machines?
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No tape or cardboard or other unapproved materials used on packaging lines?
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Trash receptacles are clearly marked and emptied when full?
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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 the company have equipment maintenance records?
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Are the maintenance records are up to date?
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Maintenance tools, supplies, and lubricants/liquids are properly stored and approved for use?
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Other GMP issues?
Quality Control Laboratory
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Instrument logs are up to date and complete?
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Calibration stickers on all pertinent equipment?
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Lab notebooks up to date and complete?
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Scales calibrated and checked daily?
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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?
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Retention room up to date and clean?
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Scale calibration system documented?
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Pest control system documented?
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Enforcement of employees not wearing earrings, jewelry, fake nails?
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Enforcement of employees wear gloves and hairnets at all times?
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Quality assurance personnel have outlined duties (SOPs) to direct them in enforcing GMPs and SOPs?
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Vendor qualifications are properly documented?
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Investigations are performed as required by GMPs?
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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?
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Training records are up to date?
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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
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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, dietary supplements, or cosmetics, enter 21 CFR 210, 21 CFR 111, or 21 CFR 700 in the search window of the FDA's home page. You may also want to view the Food, Drug, and Cosmetic Act Regulations. 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.
