Checklist for Audit in Warehouse : Pharmaceutical Guidelines

Checklist for Audit in Warehouse


Checklist to prepare for audit in warehouse/ stores.
1. Whether the storage area is adequately designed for better storage conditions? (i.e. temperature, light, humidity & cleanliness). Whether Cleaning record is maintained or not.
2. Is there adequate space for orderly storage of all starting materials, intermediates, bulk, finished product, and also a product in quarantine, released, rejected, returned, or recalled.
3. Are the materials properly checked with BOM respect to Quantity, Item code and suppliers’ name by Store & production officers and cross-checked by QA before and after dispensing?
4. Are the containers of incoming materials cleaned before storage? Is there any provision for that?
5. Whether each container of every consignment is passing the qualifications like integrity, type of materials, delivery details, material details (mfg. & exp.), PO references & damage etc?
6. Inspect process of at least one material receipt and check whether the SOP of material receipt is followed. Check that, during receipt materials are checked physically for any damage and damaged containers are treated as per SOP.

7. Whether starting materials after receiving and finished products after processing are quarantined immediately?
8. Whether the received material is properly stored with segregation and status labels?
9. Check that material requiring storage under controlled temperature are stored separately under controlled temperature.
10. Whether the SOPs are available & followed for receipt of the materials? Also, check the SOPs are of the latest version.
11. Check the material stock ledger and check the physical correctness of the material stock of one material
12. Whether each batch of each material (separate sample of separate batch No. In a single consignment) is taken for sampling, testing and release?
13. Checks that the assigned pesto-flash and roda-box. are kept at the position and check the cleaning records.
14. Check the pest control records.
15. Observe the warehouse personnel for material movement from warehouse to sampling room and dispensing room.
16. Inspect dispensing operation of one batch and check whether the SOP of dispensing is followed.
17. Whether the materials are sampled in the sampling area under RLAF booth? Whether the area is clean?
18. Whether the RLAF pressure is within the specified limit? Whether the sampling log book is maintained?
19. Check that after sampling of every raw material sampling booth is cleaned.
20. Whether the materials are segregated and stored with proper status labels of Quarantined, sampled, Under Test & Approved with a proper readable label with QC AR No.?
21. Check that after sampling of every raw material sampling booth is cleaned.
22. Whether dispensing is done in the identified areas under Reverse LAF?
23. Whether the secondary gowning procedure is followed?
24. Is there a written procedure to follow FIFO/FEFO for starting materials used in Mfg. and also the products transferred at different stages of production?
25. Whether raw materials are dispensed only by designated persons?
26. Whether each dispensed material and its weight or volume are independently checked and recorded?
27. Is there a control on unauthorized access to the printed packaging material?
28. Is the Utensils and equipment used for Dispensing of raw materials cleaned from all types of extraneous matters?
29. Are the dispensed materials with proper status labeled?
30. Is there any disposal operation after a spillage of any materials in the floor?

31. Is there provision for dispensing of raw materials as per sequence and color & actives dispensed at the last stage of Dispensing?
32. Whether packaging materials are issued by only designated persons?
33. Whether the balance is checked daily for performance checks? Whether the balance is calibrated monthly? Whether the status labels are appropriate?
34. Whether the standard weights are calibrated and stored properly?
35. Is the utensil wash area cleaned? Are the cleaned utensils stored and identified?
36. Whether each consignment/lot of material is being identified by reference number?
37. Whether outdated or obsolete primary and printed packing material is destroyed and recorded?
38. Verify the physical stock of any printed packaging material.
39. Check that packaging material of different product or strengths are segregated
40. Check that rejected material list is maintained. Check whether Material Destruction Record is maintained.
41. Is raw and packing materials stores are separated and provided with adequate space, storage racks, pallets, etc.?
42. Check the record of material issuance43. Is the approved vendor list available in the stores?
44. Are starting materials issued against an authorized work order only?
45. Is dispensing activity is carried out under RLAF or not?
46. Is dispensing checked independently by Stores / Production / QA?
47. Are the materials measured into clean, properly labeled containers?
48. Are the stocks dispensed in FIFO/FEFO order and ledgers signed by the responsible person?
49. Is dispensed area supplied with filtered air & return raiser?
50. Is adequate post measuring staging area available?
51. Is there a provision for storage or reprocessing or destruction of the rejected materials/products?
52. Whether these are recorded and approved by authorized personnel?
53. Whether the recalled products are appropriately identified and stored?
54. Is there an SOP to critically evaluate the reprocessing of the returned products or if required destruction of the same?
55. Is there a separate rejection area provided with lock and key?

56. Whether the temperature and humidity are recorded in Raw material stores and BSR? (wherever applicable)
57. Whether the temperature and humidity are recorded in Packing material stores? (wherever applicable)
58. Is there an effective system to highlight raw materials due for retesting?
59. Are there any expired raw materials in stores?
60. Is the distribution record in the finished goods stores enable specific batches to be traced?
61. Whether each container or pack is labeled appropriately during the period of storage in stores like the name of the material, code reference, batch no., lot no. & material status label like quarantine, on-test, released, rejected, returned & also retest date?

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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