Biomedical Engineering Reference
In-Depth Information
29.4
attachment form
INSPECTION OF PHYSICAL ATTRIBUTES
ABC PHARMACEUTICAL COMPANY
LEVEL 3
TABLET/CAPSULES
SOP No.: QAS-
Tablet
Tablet
Capsule
Time
No.
Hardness (kp)
Thickness (mm)
Lock/Length
Barrel No.
Limit:
Limit:
Limit:
Sample size
(mm)
1
Foreign product/odor
2
Gross foreign matter
3
Unlock capsules
4
ick & thin tablet
5
Total critical
6
defects Sample size
7
Major
8
Capping/laminated
9
Sticking
10
Dirty (specks/particles)
11
Picking >2mm
12
Dented capsule
13
Pin holes
14
Others
15
T
Total major
defects Sample size
Minor
C
hipping
Friability
D.T
Temp.
Sticking
Limit:
%
Limit:
min
RH:
Picking <2mm
Small specks
Porous surface
Before
After
%
TIME
D.T.
TIME
TEMP °C
RH %
1
Dusty capsule
2
Others
3
4
Total minor
5
d
efects Sample size
Description of any corrective action:
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