Biomedical Engineering Reference
In-Depth Information
34.5
attachment form
ANNEXURE I
Level 3
insPection of Physical attributes
caPsule
Product name:
Batch size:
Code No.:
Sample size:
Batch No.:
Description:
defects
batch siZe
samPle
accePtance
critical
siZe
aQl
0.0%
Foreign product/odor
ACC.
REJ.
Gross foreign matter
35,001 to 150,000
125
0
1
Unlock capsule
125
0
1
Cut capsule
150,001 to 500,000
200
0
1
Incorrect color/size/
200
0
1
Shape/print
500,001 and over
315
0
1
Other defects
315
0
1
Total critical
defects
Sample Size
maJor
AQL
1%
Dented capsule
ACC.
REJ.
Cracked/powder leakage
35,001 to 150,000
125
2
5
Print illegible/missing
125
6
7
Loose closure
150,001 to 500,000
200
3
7
Cap/body cutting into one
200
8
9
Another/pin hole
500,001 and over
315
5
9
Other defects
315
12
13
Total critical
defects
Sample Size
AQL
2.5%
minor
Dusty capsule
ACC.
REJ.
Print smudged
35,001 to 150,000
125
5
9
Other defects
125
12
13
150,001 to 500,000
200
7
11
200
18
19
Total critical
defects
500,001 and over
315
11
16
315
26
27
Sample Size
Disposition:
Conforms
Does not conform
Remarks:
Analyst
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