1. Is appropriate clothing worn by all personnel in production area (arm coverings when exposure to bulk and raw materials)?
2. Are the hair nets properly covering ears, hair and beard (when applicable)?
3. Are protective coverings such as gloves and aprons in a proper condition (no rips, contamination)?
4. Is the face mask properly used and covering the nose?
5. Are status tags available and correct (In Use, Dirty, Clean and Sanitized)?
6. Are all vessels with product, currently being used [ie. Should be no vessel sitting with old product in it; should be cleaned right away]
7. Is unused, clean, vessels properly covered to prevent contamination? (ex. Plastic bags, lids closed)
8. Are the equipment Clean/Sanitize Logs being filled out correctly and kept up to date, following GMPs (no open fields, skipped rows)?
NOTE: Print the equipment log for the department in the Oxygen Share Drive under Metrics / Calibration Program / Equipment Log. Select 5 instruments that are with status “IN USE” part of the list
9. Is the calibration up to date based on the calibration frequency on the log? Sticker must be visible by the calibration company on the equipment or if in house calibration log must be filled out accordingly.
10. Are the scales in good condition (ie all knobs present)?
11. Is the min value present on each scale?
12. Is the equipment in the right location as per the log?
13. If scales, was verification performed on a daily basis? Were issues found? If yes, were corrective actions taken properly?
"does not apply to the scales in the Warehouse"
14. Is the temperature of the raw material refrigerator being recorded daily? (corner of 03-04 isle in the warehouse)
44. This viscometer is calibrated every year by an outside company and verified every month by the Manufacturing Department (Liquid Manufacturing only)
15. Is the staging area clean and properly labeled (no containers from other work orders or rejected items)?
16. Is equipment not in use clear of unused materials? (Ex. components, boxes, Bulk/Raw Materials, labels etc.)
17. Are the tools properly stored? (no tools should be present on a line where batch is in process)
18. Are containers properly labeled? (Label contains correct information of the product inside the container, no multiple labels with different information)
19. Drums, buckets, boxes containing bulk have 2 labels (1 on the container and on the lid for drums and buckets- cartons have 2 labels on opposite side)
20. Is the line with materials used for the batch / work order in process with line clearance properly performed and documented - there should not been items that do not belong to the work order ?
21. Are utensils used in direct contact with product or raw material kept clean to prevent contamination? (Spatulas for mixing, weighing scoops, etc.)
22. Is disposal area properly identified?
23. Are the drums with wastage properly identified (F/A and Manufacturing)?
24. Is work station/area clear of personal items (no chewing gum, white out, medications, cell phones)?
25. Are containers free of cross out labels with hand written information (Manufacturing only)?
26. Are primary components to be used in plastic bags and in containers properly labeled? (Primary components refer to components that are in direct contact with the bulk - F/A only)
27. Is there only 1 raw material in the weighing zone (there should never be more than one RM code) (Pre-weigh only)?
45. There are no wood pallets in Pre-Weigh and Manufacturing?
48. There is no standing water on the floor"?
28. Are containers on the racks properly sealed and closed?
29. Are the bay doors closed (no gaps)?
30. Are boxes stored in the warehouse in good condition?
31. Are the material haldlers from warehouse picking up the labels authorized to do so? (employees on the labels pickup log matching the authorized list of employees that is displayed in the label storage area)
46. Is there a list with pictures, printed name, signatures and initials of the employees (per shift) allowed to pick up labels for work orders?
47. There is no food and drinks in the warehouse / quality offices located by Shipping?
32. Are all cleaning/sanitization containers properly labeled with item code, lot number/expiration date? (IPM, Alcohol, etc.)
33. Are cleaning materials away from the batch being made to avoid contamination?
34. Are all mop buckets clean with no standing dirty water?
35. Is the DI water system operational? (conductivity light on, Resistivity light Green)
36. Are all hose sanitization materials available and properly labeled?
37. Is the flush bucket available and properly labeled and without standing water?
38. Is the hose nozzle properly covered according to the procedure?
39. Is the system free of water leaks?
40. Is the DI Water system area kept clean and organized?
41. Is the DI water log book being filled out correctly and up to date (water collection, sanitization of the hose and preparation of the Sani-T-10 and Bleach solutions)?
42. Is the area absent of maintenance being performed while production running?
43. If no to the previous answer, is the maintenance being done taking precaution to avoid contamination?