Biomedical Engineering Reference
In-Depth Information
36.5
attachment forms
abc Pharmaceutical comPany
LEVEL 3
SOP No.: QAS-017
Issued on:
Revision No.:
Initiator name:
DEFECTS (ATTRIBUTES TO BE CHECKED)
From filling point
From packing
Group I
Critical defects
Clarity
Wrong batch number/expiry/mfg. dates
Less count (tablets & capsules)
Empty unit
Less fill check (liquid & granules)
Foreign material
Less removal torque
Incorrect number of units
Chipped brim
Wrong commodity
Broken plastic cap
Cracked container
Deshaped or dented tubes
Major defects
Pinholes
Missing component
Empty unit
Illegible batch number/mfg./exp. dates
Others
Improper cutting
Pitting
Cracking
Minor defects
Edges
Open label
Cavity
Crooked label
Hole
Torn label
Leak test
Excessive shrinkage
Smeared overprinting
Group II
D-shaped cartons
Liquid spills
Excessive gumming
P.P. caps broken bridges
Double labels
Cutmarks on P.P. caps
Smeared printing
Improper crimping/sealing
Improper shrink wrap
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