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?
|
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