Inspection Area

  • Area Inspected?

Facility

PPE Supplies

  • Are hairnets available to all employees via the dressing room bins?

  • Are beard nets available to all employees via the dressing room bins?

  • Are ear plugs available to all employees via the dressing room bins?

  • Are Shoe Covers available?

  • Are smocks/disposable lab coats available to all employees via the dressing room bins?

  • Are gloves located in the processing areas? (Please note any area that does not have gloves)

Hand Wash Sinks

  • Is soap available at all sinks in the area? (If No document the sink(s) and notify Housekeeping)

  • Is the water at the sinks warm? (If No document the sink(s) and notify Facilities)

  • Are hand dryers working properly? (If No document the sink(s) and notify Facilities)

  • Are hand sanitizers working properly? (If No document the sink(s) and notify Facilities)

Structural Inspection

  • Are all there any blown lights? (If Yes document area and take a picture for facilities work order)

  • Are all doors fully closed? (Interior and Exterior) If no, please document the doors that are not fully closed

  • Are all room properly tagged for there current status, i.e., (Clean, On Production, Cleaning in Process) If no, Document all rooms that are not properly tagged)

Employee Practices

Processing

  • Is First Article documented, attached to BMR and signed by QC and Production Management? (If no, document the line and product information)

  • Is line clearance occurring after product changes? (All items from previous production are not near the production line)

  • Is BMR present at the current stage of production?

  • Have materials from previous production be removed or staged for removal from the processing area? (If no, take a picture of the issue and document the area.)

  • Is all unused equipment/tools properly stored? (If no, take a picture and document the issues noted.)

  • Are broken pallets in the processing area? (If yes, take a picture and document the area.)

  • Are any miscellaneous items in the processing area that do not belong? (If yes, take a picture and document the area.)

GMP Adherence

  • Are hair nets being worn properly? (All hair should be covered as well as ears. (If not, be sure to inform lead/supervisor and document employee's name)

  • Are beard nets being properly worn? Any facial hair requires a beard net and all facial hair must be covered. (If not, be sure to inform lead/supervisor and document employee's name)

  • Are masks being worn properly? Nose must be covered. (If not, be sure to inform lead/supervisor and document employee's name)

  • Are shoe covers/booties being worm by employees without Steel-toe/facility shoes? (If not, be sure to inform lead/supervisor and document employee's name)

  • Are employees properly washing their hands prior to entering clean area of the facility? (If not, be sure to inform lead/supervisor and document employee's name)

  • Are glove being worn when in direct contact with product or any zone one equipment? (If not, be sure to inform lead/supervisor and document employee's name)

  • Are any gloves worn by those in direct product contact in good repair? Gloves should be fully intact with no tears or missing portions. (If not, be sure to inform lead/supervisor and document employee's name)

In Processing Lab

  • Have all samples been tested from the previous days production? (In-process and finished product) (If not, be sure to inform lead/supervisor and document product and lot information)

  • Have all test results been entered into QMS? (If not, be sure to inform lead/supervisor and document product and lot information)

  • Is lab in clean and orderly state? (If not, be sure to inform lead/supervisor)

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