Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
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LEVEL 3
SOP No.: QAS-011
Issued on:
Revision No:
Initiator name:
critical defects aQl 0.0%
major defects aQl 1.0%
minor defects aQl 2.5%
cumul. sample
size
lot size or batch size code letter
sample size
acc.
reJ.
acc.
reJ.
acc.
reJ.
501-1200
G
20
20
0
1
0
2
0
3
20
40
0
1
1
2
3
4
1201-3200
H
32
32
0
1
0
2
1
4
32
64
0
1
1
2
4
5
3201-10,000
J
50
50
0
1
0
3
2
5
50
100
0
1
3
4
6
7
10,001-35,000
K
80
80
0
1
1
4
3
7
80
160
0
1
4
5
8
9
35,001-150,000
L
125
125
0
1
2
5
5
9
125
250
0
1
6
7
12
13
150,001-500,000
M
200
200
0
1
3
7
7
11
200
400
0
1
8
9
18
19
500,001 and over
N
315
315
0
1
5
9
11
16
315
630
0
1
12
13
26
27
Notes: •ACC.= acceptance number, REJ. = rejection number, Cumul. = cumulative sample.
•Iftheacceptancenumberisexceededontheirstsamplebuttherejectionnumberisnotcrossed,inspectanothersample.
•Iftherejectionnumberisexceededontheirstsample,nosecondsampleistaken.
 
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