Title Page
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Conducted on
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Prepared by
Monthly GMP Audit Checklist
Personnel
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Is the hand washing procedure being followed?
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Are the soap and hand sanitizer dispensers available and full?
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Is the correct PPE worn by staff?
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Is the correct disposable PPE available for staff at the entrances to manufacturing and storage areas?
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Is the PPE worn in clean and good condition?
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Are gloves being stored correctly when not in use?
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Is the jewelry policy followed (only plain wedding band permitted)?
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Is the area free from personal belongings?
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Is there evidence of eating or drinking in the manufacturing and storage areas?
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Are only company metal detectable pens in use within the manufacturing and storage areas?
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Any other issues?
Traceability
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Is the product correctly identified
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Are the checks completed clearly and in timely manner?
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Are the scales calibrated?
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Are the documents being used have the correct version number and issue date?
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Is the product being kept off of the floor?
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Is the packaging kept off of the floor and covered where required?
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Are the filters covered when not in use and in good condition?
Hygiene
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Is there evidence of 'clean as you go' in place?
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Is the product contact equipment in good condition, clean, and stored correctly.
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Is the cleaning equipment in good condition, clean, and stored correctly?
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Are the waste bins identified and in good, hygienic condition?
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Are the floors clear of debris build-up and any spillages?
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Are the ceilings and walls clear of cobwebs, mold, etc.?
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Is the cleaning verified?
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Are the chemicals labeled and being stored properly?
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Are there any other hygiene issues?
General
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Is the fabrication of the building intact (no flaking paint or labels, damaged walls, etc.)?
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Is glass and hard plastic intact?
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Are there any engineering issues (leaking oil, tools, etc.)?
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Are there any temporary repairs?
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Do the forklift trucks pose risk to product?
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Are the pest control traps and devices maintained in good condition and in the correct positions.
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Are all doors closed/secured?
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Is the area clear of broken pieces of wood?
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Are tools locked away when not in use?
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Are sharps used in good condition and identified?
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Any other general issues?