Sr.
No. |
Check
points |
Observation |
Recommendation |
Action
Taken by |
01 |
Is the control copy of Maintenance Department
SOPs available? |
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02 |
Are the personnel having knowledge of
current GMP requirements? |
|||
03 |
Is the preventive maintenance schedule
available? |
|||
04 |
Check the preventive maintenance
records. |
|||
05 |
Are equipments labeled with last
maintenance date and next due maintenance date? |
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06 |
Are the equipment qualifications
available? |
|||
07 |
Check the equipment qualification record. |
|||
08 |
Is the temperature gauges calibration
record available? |
|||
09 |
Check the temperature gauges
calibration record. |
|||
10 |
Are the pressure / vacuum gauge
calibration record available? |
|||
11 |
Check the calibration record. |
|||
12 |
Check the break down maintenance
record. |
|||
13 |
Check the DM water generation record. |
|||
14 |
Check the AHU maintenance record. |
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15 |
Check the AHU’s filter cleaning record. |
|||
|
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16 |
Check the AHU’s differential pressure
record. |
|||
17 |
Is there any training schedule for new
entrant in maintenance department? |
|||
18 |
Are new entrant trained after join
maintenance department? |
|||
19 |
Are there any documents for
postponement of the schedule maintenance? |
|||
20 |
Is the department follow the
postponement of the schedule maintenance and send it to review by QA
department? |
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21 |
Is there check list for each equipment
for preventive maintenance? |
|||
22 |
Check the equipment check list. |
|||
23 |
Is all electrical motor labeled and
well maintained? |
|||
24 |
Check the status of the electrical motor. |
|||
25 |
Check the maintenance status of DG Set. |
|||
26 |
Is the maintenance store area clean? |
|||
27 |
Check the housekeeping of maintenance
store area. |
|||
28 |
Are all storage tanks properly labeled? |
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