HOT POST

50/recent/ticker-posts

Header Ads Widget

SOP for Printed Packaging Material Inspection Plan


OBJECTIVE
To lay down a procedure for Printed packaging material inspection plan.

SCOPE
This procedure applies to the pharmaceutical manufacturing facilities of XYZ Limited.

RESPONSIBILITY
The Quality Control Chemist is responsible for implementation of the process.
The Quality Control Manager is responsible for the execution of the procedure.

PROCEDURE
  • Critical: These are unacceptable at any level because they affect the function of the product. They will inevitably cause product recall.
  • Major- These are acceptable at low levels. They affect acceptability of the product, not the function.
  • Anything not specified as critical or major, less important for the function or use to the product. acceptable at high levels.
  • Each printed material shall be examined individually during issuance as specified below;

PEOPLE ALSO READ: SOP for Handling and Storage of Control Samples

Cartons

Observe for

Defect

Mis-printing       

Critical

Missing text Matter       

Critical

Bad cutting And Creasing

Major

Self-Lock Bottom Pasting

Major

Ghost Images

Major

Colour Variation

Major

Wrong Paper Material

Major

Labels

Miss printing

Critical

Missing text Matter 

Critical

Bad cutting

Major

Ghost Images    

Major

Colour Variation

Minor

Wrong Paper Material

Major

Ink Stains

Major

Shippers

Missing text Matter

Critical

Miss printing

Critical

Wrong Cutting

Minor

Ghost Images

Minor


Defect

Acceptance Quality Level

Critical

NIL (0)

Major

2%

Minor

10%


  • On receipt of each consignment, sample randomly from about 3 boxes one bundle from each and inspect for the various defects. If there are critical defects, reject the consignment.
  • Major Defects shouldn’t exceed 2%.
  • Minor defects shouldn’t exceed 10%
  • During Issuance labels with defects shall be sorted out and rejected.

ABBREVIATION(s)
SOP : Standard Operating Procedure
Q.A : Quality Assurance
No. : Number
Q.C : Quality control

ANNEXURE(s)
Nil.

Post a Comment

0 Comments

close