Biomedical Engineering Reference
In-Depth Information
33.5
attachment forms
abc Pharmaceutical comPany
LEVEL 3
SOP No.: QAS-014
Issued on:
Revision No.:
Initiator name:
ANNEXURE I
DEFECTS (ATTRIBUTES TO BE CHECKED)
From Filling Point
From Packing
Group I
Critical defects
Clarity
Wrong batch number/expiry/mfg. dates
Less count (tablets and capsules)
Empty unit
Less fill check (liquid and granules)
Foreign material
Less removal torque
Incorrect number of units
Chipped brim
Broken plastic cap
Cracked container
Deshaped or dented tubes
Major defects
Pinholes
Wrong commodity
Empty unit
Missing component
Improper cutting
Illegible batch number/mfg./expiry dates
Pitting
Others
Cracking
Edges
Minor defects
Cavity
Open label
Hole
Crooked label
Torn label
Excessive shrinkage
Group II
Smeared overprinting
Liquid spills
D-shaped cartons
P.P. caps broken bridges
Excessive gumming
Cutmarks on P.P. caps
Double labels
Improper crimping/sealing
Smeared printing
Leak test
Improper shrink wrap
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