Checklist for USFDA Audit Preparation in Quality Control : Pharmaceutical Guidelines

Checklist for USFDA Audit Preparation in Quality Control


Following are the points those must be checked and implemented before the USFDA audit in the quality control laboratory.
1. Verification/updating of specimen signature log.
2. Review of QC manuals and its updation.
3. Analyst certification according to the current job description.
4. Individuals training file updation.
5. Analyst certification schedule and its compliance in last 3 years.
6. Training record review as per the current job.
7. The availability of current specification.
8. Physical availability of the stability protocols.
9. Stability sample indexing and reconciliation of samples.
10. Checking of obsolete/ expired/ any old unwanted documentation in the individual sections of QC and their appropriate disposal.

11. Review of the GTPs for their current versions.
12. Index of working standards /impurity standards and their reconciliation of quantities.
13. Physical presence and review of calibration of all the equipments in individual sections.
14. IQ, OQ & PQ of Instrument / Equipments and their review.
15. Listing of all the equipments section wise and their maintenance records.
16. Verification and labeling as per SOP of Reagent / Indicator with expiry, removal of expired items.
17. Checking of the calibration ranges for QC Equipments w.r.t to the actual operating range [especially for ovens, incubators, muffle furnace, thermometers etc].
18. Review of volumetric solutions record and also the review of their shelf life determination documentation.
19. Removal of broken glassware.
20. Removal of any unwanted items/documents/personal belongings.
21. Removal of unwanted equipment / very old equipment/ accessory fittings.
22. Cleaning of PCs for any unwanted files.
23. Indexing of the documents kept in QC and to ensure the access control with lock and key.
24. Library arrangement & indexing of library.
25. Review of working standard records of last 3 years.
26. Outside party calibration reports and its review w.r.t their current traceability standards.
27. Cleaning of personal lockers for any unwanted items/ documents.
28. Review of preventive maintenance schedule & Breakdown reports.
29. Housekeeping and cleaning of the lab.
30. Cleaning of the area below the staircase.
31. Chamber calibration & its validation.
32. Temp. mapping of refrigerator, autoclave and chambers.
33. Temp. study of WS chamber/refrigerator.
34. Temp. study products, raw data and compiled report and list.
35. GC lab silica gel verification/replacement if required.
36. Proper marking and maintenance of GC lines.
37. Availability and usage of PPE and lab safety equipments.
38. Glassware cleaning validation review for all labs inclusive of reusable HPLC / GC vials.
39. Proper labeling of drawers/shelves.
40. Cleaning of hot room/ storage in surroundings.

41. Verification of HPLC & GC column records.
42. Training of workmen.
43. Review of validation of calculators.
44. Review of validation of excel sheet.
45. Availability of the Class A certificates of glassware.
46. Verification and review of AR number register of all sections.
47. Sample storage condition checking.
48. Disposal of leftover samples.
49. Contract lab Audit Schedule & its audit files.
50. Verification and working of existing fire extinguisher and other safety equipment.
51. Safety shower/eye washer verification and safety training.
52. Review of AMCs and service reports of QC instruments.
53. Traceability of calibration data sheets.
54. Master list of calibrators used for calibration with a proper review.
55. Reviewed of all instrument/ equipment usage logs and others logs.
56. HPLC & GC data back-up SOP to check for its actual compliance and challenge.
57. Reconciliation of WS vials/stability samples.
58. Stock verification of WS/RS/TS.
59. Analytical method validation availability of FP.
60. Analytical method validation availability of cleaning method validation.

61. Analytical method validation availability of IP.
62. Analytical method validation availability of FP/IP/RM.
63. Review of all pH meters for their standardization procedures and logs.
64. Review of all the balances for their calibrations with respect to the current standard weight box.
65. Checking of available weight boxes and physical checking of weights.
66. Review and checking of the traceability certificate for weights.
67. Availability of MSDS in the lab for all reagents and chemicals.
68. List of the hazardous chemicals used and its SOP availability.
69. Physical availability of all the sieves with their certifications.
70. Availability of magnifying glass near the storage places of single-use vials of working standards.
71. List of test performed from outside lab.
72. List of approved contract laboratory.
73. Raw data review of RM.
74. Raw data review of the formulation (FP and stability).
75. Raw data review of cross-contamination study.





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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