Global Pharmaceuticals Pvt. Ltd.

SOR 17054 Effective Date Review date Revision 00

01-04-2020 31-03-2022
Internal Audit Checklist Page 1 of 4

ENGINEERING
Department Section

Auditee Name Sign

25/05/2021 Target Date for
Audit Date
Completion
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Participant (Auditor)
Name Designation Signature/ Date

Lead Auditor

Note: During Inspection CAPA will be raised where system needs improvement / amendments.
 Global Pharmaceuticals Pvt. Ltd.
SOR 17054 Effective Date Review date Revision 00
01-04-2020 31-03-2022
Internal Audit Checklist Page 2 of 4

Observations
(Tick the relevant)
Yes No Comments
ENGINEERING
A) HOUSE KEEPING
1. Is the area properly cleaned and dusted?
2. Are waste bins cleaned and closed?
Does the floors, walls, windows, ceilings, doors, tables, etc properly
3.
clean?
Are the tube lights, electrical switches/panels cleaned and free from
4.
dust?
B) EQUIPMENT
Are written operating procedures available for each equipment /
5.
machines used in factory to perform respective operation?
6. Are all equipment / machines suitable in their size / capacity?
7. Are the equipment / machines properly designed and installed?
Are clean instruments and tools used for the maintenance
8.
equipment/machines?
9. Are all equipment of Central Utility area identified and tagged properly?
C) CALIBRATION
10. Are calibration tags available on all equipment?

D)
PERSONNEL
Is sufficient number of personnel available in engineering department
11. to fulfill all responsibilities?
12. Does all responsible staff have their specific duties recorded in
written job descriptions?
13. Are all personnel aware about their job responsibilities and GMP
principles?
14. Are all personnel trained in the practices of personal hygiene?
15. Have the employees undergone training in the following areas on
yearly basis?
 Job responsibilities
 Good manufacturing practices
 Standard operating procedures
 Equipment/ machines
 AHUs.
 Global Pharmaceuticals Pvt. Ltd.
SOR 17054 Effective Date Review date Revision 00
01-04-2020 31-03-2022
Internal Audit Checklist Page 3 of 4

Observations
(Tick the relevant)
Yes No Comments
 Water System
16. Is the training record available and maintained?
17. Question several employees about the operations they are performing.
Are they knowledgeable about their job functions?
18. Are all personnel wearing uniforms along with face masks, safety
goggles and safety shoes?
E) DOCUMENTATION
19. Are documentation meticulously maintained as per rules and kept up to
date?
20. Is the record of written procedures for each activity performed
available and maintained?
21. Is there an organogram for the departments?
22. Does department have mechanical drawings and maintenance manual
of all manufacturing equipment?
23. Is preventive maintenance done as per schedule and record kept?
24. Are proper breakdown entries made in history card?
25. Are written records for maintenance of all equipment/machines and
their parts available and maintained?
26. Check whether calibration/validation for all key equipment is carried
out as per relevant Performance Qualification Protocol and record kept
and maintained for:
a. Air Compressors
b. Effluent Treatment Plant (ETP) etc
27. Is the list of equipment/machines available?
28. Is the IQ, OP and PQ done for new equipment and record thereof
maintained?
29. Are records maintained if documented procedure changes due to
CAPA?
F) General Considerations
i) WATER SUPPLY
30. Is there any SOP available for water system?
31. Is line diagram of water system available and updated?
32. Is there any deviation and change control reports available for water
system?
33. Are log books of incidents, filter changes, shut down periods,
 Global Pharmaceuticals Pvt. Ltd.
SOR 17054 Effective Date Review date Revision 00
01-04-2020 31-03-2022
Internal Audit Checklist Page 4 of 4

Observations
(Tick the relevant)
Yes No Comments
cleaning/sanitization, maintenance available and maintained?
34. Is there adequate supply of purified and potable water?
35. Are the Water treatment records available and maintained?
36. Is the water quality as per specifications and record thereof being kept/
maintained?
37. Is direction of the water flow clearly labeled?
38. Are the covers of the main water holding tank locked?
39. Is access to the main water holding tank for the factory
restricted?
40. Examine the validation file for the purified water system

ii) HVAC
41. Is there any SOP available for HVAC system?
42. Are there any validation protocols available for HVAC?
43. Are the Log books for maintenance and calibration of HVAC available
and maintained?
44. Is line diagram of HVAC available and updated?
45. Are the ducts of HVAC system are properly identified and cleaned?
46. Is the position of inlets and air return acceptable as per GMP?
47. Is cleaning of HVAC filters done as per SOP and the record thereof
maintained?
48. Are all filters with proper identification mark?
49. Is the smoke test done?
50. Are rooms for the production of products equipped with HVAC in
accordance with GMP requirements?
51. Is there any HVAC alarm system available for KPI’s out of
specification?
52. Is there any deviation and change control reports available for HVAC?
53. Is buffer stock of filters kept?
54. Is preventive maintenance done as per schedule?
55. Are safety wears used during maintenance work?