Internal Audit check list for QC department
Internal Audit check list for Production department
Internal Audit check list for Production department
Sr. No. | Check points | Observation (Yes/No) | Comments | Recommendation | Action taken by |
1. | Is the control copy of production department SOPs available? | ||||
2. | Are the personnel having knowledge of current GMP requirements? | ||||
3. | Are the lots of raw material properly stored? | ||||
4. | Are the lots of raw material having proper labels of status? | ||||
5. | Is the housekeeping maintained? | ||||
6. | Is the weighting balance having proper tag of calibration status? | ||||
7. | Is the balance calibration record available? | ||||
8. | Are the calibrated standard weights available? | ||||
9. | Is the calibration certificate available? | ||||
10. | Is the standard weights are properly stored? | ||||
11. | Is the reactor area cleaned? | ||||
12. | Is the status label of reactor available? | ||||
13. | Is the BMR requisition slip record available? | ||||
14. | Check the calibration status of temperature gauges. | ||||
15. | Check the calibration status of pressure gauges. | ||||
16. | Check the status of centrifuge. | ||||
17. | Check the cleaning of centrifuge and centrifuging area. | ||||
18. | Check the condition of centrifuge bags. | ||||
19. | Check the status of dryer. | ||||
20. | Check the cleaning of dryer and drying area. | ||||
21. | Check the calibration status of temp, Gauge of dryer. | ||||
22. | Check the trays and trolley condition. | ||||
23. | Check the status of sifter. | ||||
24. | Check the cleaning of sifting area. | ||||
25. | Check the status of multi mill. | ||||
26. | Check the cleaning of milling area. | ||||
27. | Check the finished product packing area. | ||||
28. | Check the availability and stock of packing materials. | ||||
29. | Check the temperature and humidity record. | ||||
30. | Check the cleaning of sampling devices. | ||||
31. | Are all the sampling devices properly stored? | ||||
32. | Check the general cleaning and housekeeping of plant. | ||||
33. | Check the test request slip record. | ||||
34. | Check the personnel hygiene. | ||||
35. | Check the safety equipments. | ||||
36. | Check the other records. | ||||
37. | Is ECR available? | ||||
38. | Check the ECR. | ||||
39. | Check the condition of reactors. | ||||
40. | Are there work instruction labeled on all equipments. | ||||
41. | Are records maintained for Solvent Receipt, Usage & Recovery In Plant? | ||||
42. | Check the records of Solvent Receipt, Usage & Recovery In Plant. | ||||
43. | Is there any training record for new employee? | ||||
44. | Check the training record and training schedule. | ||||
45. | Is the pipeline properly marked with directional arrows? | ||||
46. | Is logbook of all Equipment properly maintained? |