1.0 Objective: To lay down the procedure for handling filled bottles labeled with improper labels.|
2.0 Scope:
This procedure is applicable for filled bottles with improper labels in the liquid packing department in Pharmaceuticals
3.0 Responsibility:
Officer – Production department to implement this standard operating procedure.
Manager- Production Department to overall compliance to this operating procedure
4.0 Procedure:
4.1 Types of improper labels can be listed as:
4.1.1 Improper printing on labels during printing.
4.1.2 Smudging of ink on labels during printing.
4.1.3 Slant label (improper pasting/alignment) during printing.
4.1.4 Untidy appearance (i.e. ink spot etc.) during the printing.
4.1.5 Colour, shade, variation on the label, etc.
4.2 Take purified water in an empty cleaned tray and place the bottle with improper labels vertically allow in the tray. The labeled portion is to soak for sufficient time. Ensure that the water level in-tray is not above the label level of the bottle and below the neck of the bottle.
4.3 After the socking time Remove the soaked labels from the bottle manually and wipe the outer surface of the bottles using the dry lint-free white cloth to dry.
4.4 Re-label the bottles with fresh labels.
5.0 abbreviations:
SOP: Standard operating procedure
No. : Number
NA: Not applicable
6.0 Reference
NA
7.0 Annexure
Nil
8.0 Distribution
8.1 Master copy: Quality Assurance
8.2 Controlled copy ( s): Production department
8.3 Reference copy (s): Production department
Related SOP: SOP on inspection unit for empty and filled bottles
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