Standard Operating Procedure for Labeling of Transdermal Patches

1) Purpose

The purpose of this SOP is to define the procedure for labeling transdermal patches to ensure accurate and compliant labeling for identification, traceability, and regulatory adherence.

2) Scope

This SOP applies to all labeling activities for transdermal patches within the facility, including preparation, printing, application, and inspection of labels.

3) Responsibilities

The Labeling Department is responsible for executing the labeling process as per this SOP. The Labeling Manager ensures compliance with the procedure and regulatory requirements.

4) Procedure

4.1 Preparation

• 4.1.1 Verify the cleanliness and readiness of the labeling area and equipment.
• 4.1.2 Ensure the availability of approved label templates and materials.
• 4.1.3 Review the batch labeling record for accuracy and completeness.

4.2 Label Printing

• 4.2.1 Load the printer with the appropriate label stock.
• 4.2.2 Select the approved label template for the specific batch.
• 4.2.3 Print a test label and inspect for clarity, accuracy, and compliance.
• 4.2.4 Print the required number of labels for the batch.

4.3 Label Application

• 4.3.1 Verify the printed labels against the approved label copy.
• 4.3.2 Apply the labels to the primary and secondary packaging of the transdermal patches.
• 4.3.3 Ensure that the labels are affixed securely and correctly positioned.

4.4 Inspection and Verification

• 4.4.1 Conduct an inspection of the labeled packages to check for accuracy and legibility.
• 4.4.2 Verify the batch number, expiry date, and other critical information on the labels.
• 4.4.3 Document any discrepancies or deviations observed during inspection.

4.5 Documentation

• 4.5.1 Record all labeling activities in the batch labeling record.
• 4.5.2 Retain samples of labeled packages as per retention policy.
• 4.5.3 Archive all labeling records as per regulatory requirements.

5) Abbreviations, if any

None

6) Documents, if any

Batch Labeling Record
Approved Label Templates

7) Reference, if any

21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
FDA Guidance for Industry: Labeling for Human Prescription Drug and Biological Products

8) SOP Version

Version 1.0