SOP for Printed Packaging Material Inspection Plan

OBJECTIVE

To lay down a procedure for the 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 the 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 recalls.
• Major- These are acceptable at low levels. They affect the 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;

ALSO READ: SOP for Testing and Release of Packing Materials

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

SOP: Standard Operating Procedure

Q.A: Quality Assurance

No.: Number

Q.C: Quality control

ANNEXURE

Nil.

ALSO READ: SOP for Good Documentation Practice