Monthly GMP Audit - CA

• Conducted on

  Date

• Prepared by

• Location

  Select

Previous inspection/corrective & preventative action review

• Has the previous month's inspection been reviewed by the management team?

  Yes

  No

  N/A

• Have all corrective/preventative actions been implemented from the previous inspection?

  Yes

  No

  N/A

• Corrective/preventative action items are not past due or behind schedule?

  Yes

  No

  N/A

• Have temporary measures been implemented for corrective actions that require capital projects or otherwise cannot be implemented immediately?

  Yes

  No

  N/A

Liquid production room

• Clean and orderly?

  Yes

  No

  N/A

• No evidence of off odors?

  Yes

  No

  N/A

• All lights functional, with no missing bulbs?

  Yes

  No

  N/A

• Adequate drainage and cleanable floor surface?

  Yes

  No

  N/A

• All walls, ceiling, and floor cleanable?

  Yes

  No

  N/A

• No signs of flaking or peeling paint?

  Yes

  No

  N/A

• Processing equipment clean and sanitary?

  Yes

  No

  N/A

• Covers in place over production equipment?

  Yes

  No

  N/A

• Mixing utensils and equipment clean and stored in a sanitary manner?

  Yes

  No

  N/A

• All fittings, spouts, clamps, gaskets, and filters stored in a clean and sanitary manner?

  Yes

  No

  N/A

• Cleaning supplies and equipment properly stored?

  Yes

  No

  N/A

• Compliance with GMP for buckets and brushes?

  Yes

  No

  N/A

• Review of MSS records show no deficiencies?

  Yes

  No

  N/A

Powder production room

• Clean and orderly?

  Yes

  No

  N/A

• No evidence of off odors?

  Yes

  No

  N/A

• All lights functional, with no missing bulbs?

  Yes

  No

  N/A

• Adequate drainage and cleanable floor surface?

  Yes

  No

  N/A

• All walls, ceiling, and floor cleanable?

  Yes

  No

  N/A

• No signs of flaking or peeling paint?

  Yes

  No

  N/A

• Processing equipment clean and sanitary?

  Yes

  No

  N/A

• Covers in place over production equipment?

  Yes

  No

  N/A

• Mixing utensils and equipment clean and stored in a sanitary manner?

  Yes

  No

  N/A

• All fittings, spouts, clamps, gaskets, and filters stored in a clean and sanitary manner?

  Yes

  No

  N/A

• Cleaning supplies and equipment properly stored?

  Yes

  No

  N/A

• Compliance with GMP for buckets and brushes?

  Yes

  No

  N/A

Refrigerated storage

• Clean and orderly?

  Yes

  No

  N/A

• No evidence of off odors?

  Yes

  No

  N/A

• All product properly sealed and packaged?

  Yes

  No

  N/A

• No product spills?

  Yes

  No

  N/A

• Proper product identification is visible?

  Yes

  No

  N/A

• All products stored on pallets in an orderly manner to reduce risk for damage/cross contamination?

  Yes

  No

  N/A

• Cold box temperature recording log in order?

  Yes

  No

  N/A

Flammable Room

• Clean and orderly?

  Yes

  No

  N/A

• No evidence of off odors?

  Yes

  No

  N/A

• All lights functional, with no missing bulbs?

  Yes

  No

  N/A

• All product properly sealed and packaged?

  Yes

  No

  N/A

• Rodent stations properly working, clean and in proper locations?

  Yes

  No

  N/A

• Proper product identification is visible?

  Yes

  No

  N/A

• All products stored on pallets in an orderly manner to reduce risk for damage/cross contamination?

  Yes

  No

  N/A

Finished Products Location

• Clean and orderly?

  Yes

  No

  N/A

• No evidence of off odors?

  Yes

  No

  N/A

• 18" warehouse buffer zone maintained?

  Yes

  No

  N/A

• All lights functional, with no missing bulbs?

  Yes

  No

  N/A

• No evidence of product spills. Any spills are cleaned immediately.

  Yes

  No

  N/A

• All product properly sealed and packaged?

  Yes

  No

  N/A

• Proper product identification is visible?

  Yes

  No

  N/A

• Rodent stations properly working, clean and in proper locations?

  Yes

  No

  N/A

Incoming raw material and bulk powder storage area

• Clean and orderly?

  Yes

  No

  N/A

• No evidence of off odors?

  Yes

  No

  N/A

• 18" warehouse buffer zone maintained?

  Yes

  No

  N/A

• All lights functional, with no missing bulbs?

  Yes

  No

  N/A

• All product properly sealed and packaged?

  Yes

  No

  N/A

• Proper product identification is visible?

  Yes

  No

  N/A

• Rodent stations properly working, clean and in proper locations?

  Yes

  No

  N/A

• All entrances can be secured properly?

  Yes

  No

  N/A

• Raw materials and key expiration check- randomly choose one raw material and one key from warehouse shelves, refrigerator, or drum racks and inspect for compliance with expiration date program (2.4.9 Stock Rotation). <br><br>Take a photo of RM / key label. Are the selected items in compliance?<br><br>Note discrepancies.

  Yes

  No

  N/A

Shipping and receiving docks area

• Clean and orderly?

  Yes

  No

  N/A

• No evidence of off odors?

  Yes

  No

  N/A

• All lights functional, with no missing bulbs?

  Yes

  No

  N/A

• 18" warehouse buffer zone maintained?

  Yes

  No

  N/A

• Product in quarantine area clearly labeled?

  Yes

  No

  N/A

• All product properly sealed and packaged?

  Yes

  No

  N/A

• Proper product identification is visible?

  Yes

  No

  N/A

• Rodent stations properly working, clean and in proper locations?

  Yes

  No

  N/A

• Review of shipping and receiving paperwork shows no gaps or missing information?

  Yes

  No

  N/A

Warehouse

• Clean and orderly?

  Yes

  No

  N/A

• No evidence of off odors?

  Yes

  No

  N/A

• All products stored on pallets in an orderly manner to reduce risk for damage/cross contamination?

  Yes

  No

  N/A

• All lights functional, with no missing bulbs?

  Yes

  No

  N/A

• All product properly sealed and packaged?

  Yes

  No

  N/A

• Rodent stations properly working, clean and in proper locations?

  Yes

  No

  N/A

• Proper product identification is visible?

  Yes

  No

  N/A

• Laboratory storage racks orderly and clean?

  Yes

  No

  N/A

• Glass pouring station kept neat and orderly to prevent cross contamination/adulteration.

  Yes

  No

  N/A

Key Production Room

• Clean and orderly?

  Yes

  No

  N/A

• All lights functional, with no missing bulbs?

  Yes

  No

  N/A

• All walls, ceiling, and floor cleanable?

  Yes

  No

  N/A

• No signs of flaking or peeling paint?

  Yes

  No

  N/A

• Processing equipment clean and sanitary?

  Yes

  No

  N/A

• Covers in place over production equipment?

  Yes

  No

  N/A

• Mixing utensils and equipment clean and stored in a sanitary manner?

  Yes

  No

  N/A

Sanitation Chemicals Room

• Clean and orderly?

  Yes

  No

  N/A

• Compliance with GMP for buckets and brushes?

  Yes

  No

  N/A

• Chemical Inventory Log current?

  Yes

  No

  N/A

Personal hygiene compliance observations

• Hairnets and beard nets worn properly?

  Yes

  No

  N/A

• Uniforms and lab coats are clean and worn properly?

  Yes

  No

  N/A

• Everyone is washing and sanitizing hands?

  Yes

  No

  N/A

• No one is wearing jewelry in plant?

  Yes

  No

  N/A

• Shoes and boots are clean and in good condition?

  Yes

  No

  N/A

• Work areas are clean and orderly?

  Yes

  No

  N/A

• Color coding for buckets and utensils being followed per the policy guidelines?

  Yes

  No

  N/A

• No injuries or illnesses are present in personnel in the plant?

  Yes

  No

  N/A

• No tobacco, gum, candy, drinks, false fingernails, fingernail polish, items in shirt pockets, and medications are found in plant?

  Yes

  No

  N/A

Break room, Restrooms and Locker room areas

• Clean and orderly?

  Yes

  No

  N/A

• Refrigerator is orderly and clean?

  Yes

  No

  N/A

• All trash disposed of properly?

  Yes

  No

  N/A

• No evidence of food stored in lockers?

  Yes

  No

  N/A

• Employee locker area is orderly and clean?

  Yes

  No

  N/A

• Toilets are clean and orderly?

  Yes

  No

  N/A

• Paper towels, soap, and warm water available for proper hand washing?

  Yes

  No

  N/A

Exterior building & grounds

• Litter free?

  Yes

  No

  N/A

• Signs of infestation?

  Yes

  No

  N/A

• Area under dumpster clean?

  Yes

  No

  N/A

• No evidence of off odors?

  Yes

  No

  N/A

• All doors and windows closed with no visible gaps?

  Yes

  No

  N/A

• Building entrances secured?

  Yes

  No

  N/A

• Rodent stations properly working, clean and in proper locations?

  Yes

  No

  N/A