Biomedical Engineering Reference
In-Depth Information
30.5
attachment forms
abc Pharmaceutical comPany
SOP No.:
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 No./expiry/mfg.
Less count (tablet and capsule)
Wrong special stamping
Less fill check (liquid and granules)
Empty unit
Less removal torque
Foreign material
Chipped brim
Incorrect number of unit
Broken plastic cap
Cracked container
Major Defects
Deshaped tubes, dented tubes
Wrong commodity
Pin holes
Missing component
Empty unit
Illegible batch No./mfg./expiry
Improper cutting
+ Others
Pitting
Cracking
Minor Defects
Edges
Open label
Cavity
Crooked label
Hole
Torn label
Split apex in suppository
Excessive shrinkage
Air bubbles
Smeared overprinting
D-shaped cartons
Group II
Excessive Gumming
Liquid spills
Double labels
P.P. caps broken bridges
Smeared printing
Cutmarks on P.P. caps
Improper shrink wrap
Improper crimping/sealing
Leak test
Rough surface (suppository)
Concave pit (suppository)
Shiny/dull (suppository)
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