Sr. No. | Check points | Observation (Yes/No) | Comments | Recommendation | Action taken by |
01 | Is the control copy of Maintenance department SOPs available? | | | | |
02 | Is 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? | | | | |
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. | | | | |
15 | Check the AHU’s filter cleaning record. | | | | |
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? | | | | |
21 | Is there check list for each equipment for preventive maintenance? | | | | |
22 | Check the equipment check list. | | | | |
23 | Are 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? | | | | |
This Blog is created for the updation of knowledge on Quality Assurance, current Good Manufacturing Practices (cGMP) and current Updates from all regulatory authorities. Also one can archive Standard Operating Procedures (SOPs), specification and pharma jobs etc. for any Pharma plant.
Friday, December 24, 2010
Internal Audit Check list for Maintenance department
Internal Audit Check list for Maintenance department
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