Standard Operating Procedure for Label Inspection for Transdermal Patches

1) Purpose

To define procedures for inspecting labels used in the packaging of transdermal patches to ensure accuracy, consistency, and compliance with regulatory requirements.

2) Scope

This SOP applies to the quality control department responsible for inspecting labels during the packaging process of transdermal patches.

3) Responsibilities

3.1 Quality Control Inspector: Perform label inspections according to defined procedures.
3.2 Production Supervisor: Ensure labels are applied correctly and in accordance with approved artwork.
3.3 QA Personnel: Review and approve label inspection procedures and reports.
3.4 Regulatory Affairs: Ensure compliance with labeling regulations and requirements.

4) Procedure

4.1 Label Inspection Setup:

4.1.1 Verify the availability of correct label stock and artwork specifications.

4.1.2 Prepare inspection area with adequate lighting and magnification tools if necessary.

4.2 Inspection Process:

4.2.1 Retrieve labeled transdermal patches from the packaging line at predefined intervals.

4.2.2 Compare labels against the approved artwork and specifications.

4.2.3 Inspect for correct text, fonts, colors, barcodes, lot numbers, and expiration dates.

4.3 Defect Identification:

4.3.1 Identify and document any labeling defects or discrepancies.

4.3.2 Classify defects