Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
LEVEL 3
SOP No.: QAS-017
Issued on:
Revision No.:
Initiator name:
MILITARY STANDARD SAMPLING PLAN FOR VARIOUS CONTROL LEVELS FOR
PROCESS AUDIT FILL CHECKS FROM FILLING POINT
grouP ii
check
accePtance
number
reJection
number
Clarity
1st
5 Units
0
2
2nd
5 Units
Combined
10 Units
1
2
Less counts
1st
5 Units
0
2
2nd
5 Units
Combined
10 Units
1
2
Less fill checks (liquid)
1st
2nd
Combined
As per the number of nozzles of the machines and
none should be out of in-process limits for different
production dosage forms
Less fill checks (granules)
1st
2nd
Combined
3 Units
None should be out of in-process
limits
Less removal torque
1st
5 Units
0
2
(Liquid & granules)
2nd
5 Units
Combined
10 Units
1
2
Cotton or silica
1st
5 Units
0
2
2nd
5 Units
Combined
10 Units
1
2
Chipped brim
1st
5 Units
0
2
2nd
5 Units
Combined
10 Units
1
2
Broken plastic cap
1st
20 Units
0
2
Cracked container
2nd
20 Units
Combined
40 Units
1
2
Leak test (liquid)
1st
13 Units
0
2
2nd
13 Units
Combined
26 Units
1
2
grouP ii
Liquid spill
1st
13
1
4
PP caps broken bridges
2nd
13
Cut marks on caps
Combined
26
4
5
Improper sealing/crimping
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