Self Audit Checklist for Quality Control Department
Sr.
No.
Check
points
Observation
Recommendation
Action
taken
by
01
Is the control copy of QC department
SOP’s available?
02
Are the personnel having knowledge of
current GMP requirements?
03
Is the housekeeping maintained?
04
Is the weighting balance having proper
tag of calibration status?
05
Is the balance calibration record
available?
06
Are the calibrated standard weights
available?
07
Is the calibration certificates
available?
08
Is the standard weights are properly
stored?
09
Are the status labels
available on each instrument?
10
Is the instrument calibration record
available?
11
Check the temperature and humidity
record.
12
Check the cleaning record.
13
Check the cleaning of sampling devices.
14
Are all the sampling devices properly
stored?
15
Check the general cleaning and
housekeeping of QC.
16
Are the specifications available for
raw material, packing material, in-process samples, intermediates and
finished products?
17
Check the in-process testing record.
18
Check the raw material testing record.
19
Check the final product testing record.
20
Check the stability record.
21
Check the stability chamber record.
22
Check the solution preparation and
standardize record.
23
Check the control sample record.
24
Check all instrument log book.
25
Check the primary standards and its
storage.
26
Check the mobile phase status of GC and
HPLC.
27
Check the HPLC column record.
28
Check the test request slip record.
29
Check the personnel hygiene.
30
Check the safety equipments.
31
Check the other records.
32
Check the environment where control
sample store?.
33
Is log book of destruction of control
sample is maintained?
34
Is the out of calibrated instrument
well labeled?
35
Is QC Chemist validated?
36
Is the sample in QC lab well labeled?
37
Are the personnel following GLP?
38
Are training given to new
personnel?
39
Are all QC personnel in proper dress
code?
40
Is glassware breakage log book
maintained?
41
Check DM water analysis record.
42
Check reference standard records?
43
Is proper sampling plan available?
