Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-007.00 Effective date: mm/dd/yyyy
Approved by:
26.3.5 d
efinitionS
of
d
efectS
r
elated
to
u
ncoated
t
aBletS
Critical defects
Foreign tablets: Any tablet other than the actual product.
Major defects
A. Capping
: Any tablet showing separation of a part of tablet partly or throughout its horizontal
axis. Such tablets may or may not break into two parts.
B. Broken
: Any tablet broken into two or more pieces.
C. Picking
: Any tablet having depression of 2 mm or more on its surface.
D. Dirty
: Any tablet with a spot of different color (not due to entrapped specks) or oil spots
from machine.
E. Large
: Any tablet with entrapped speck or foreign material of 2 mm or more in size.
Minor defects
A. Picking
:
A depression of less than 2 mm in size.
B. Small specks
:
Specks of less than 2 mm in size.
C. Porous surface :
Unsmooth surface, resulting in loss of shine.
26.3.6
d
efinition
of
“d
efective
”
a.
Critical defective
: Critical defective by virtue of having one or more critical defects.
Additionally a critical defective can have major or minor defects as well.
b.
Major defective
: By virtue of having one or more major defects. Additionally, a major
defective can have minor defects but no critical defects.
c.
Minor defective
: By virtue of having one or more minor defects. A minor defective does
not have major or critical defects.
26.3.7 d
ocumentation
The findings/results will be entered in the format for physical attributes of coated or core tablets.
The disposition will be decided on the basis of the acceptance plan attached.
a. If the sample is having defectives less than or equal to the acceptance number, then the lot
is accepted.
b. If the sample is having defectives equal to or more than the rejected, then the lot is rejected.
c. Whereas if defectives are more than the acceptance number but less than the rejected num-
ber, then a second sample of the same size is taken and is inspected and the disposition is
decided on the cumulative sample (the first and the second).
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