Standard Operating Procedure for Packaging of Transdermal Patches

1) Purpose

The purpose of this SOP is to define the process for packaging transdermal patches to ensure product integrity, protection, and compliance with regulatory standards.

2) Scope

This SOP applies to all packaging activities related to transdermal patches within the facility, covering the preparation, packaging process, labeling, and final inspection.

3) Responsibilities

The Packaging Department is responsible for carrying out the packaging process as per this SOP. The Packaging Manager ensures adherence to the procedure and maintains the necessary documentation.

4) Procedure

4.1 Preparation

• 4.1.1 Verify the cleanliness and readiness of the packaging area and equipment.
• 4.1.2 Ensure all packaging materials are available and meet the required specifications.
• 4.1.3 Review the batch packaging record for completeness and accuracy.

4.2 Packaging Process

• 4.2.1 Primary Packaging:
  • 4.2.1.1 Load the transdermal patches into the designated packaging machine.
  • 4.2.1.2 Operate the machine to seal each patch in its individual pouch or blister pack.
  • 4.2.1.3 Inspect the sealed packages for defects or damage.
• 4.2.2 Secondary Packaging:
  • 4.2.2.1 Group the primary packaged units as per the packaging instructions.
  • 4.2.2.2 Place the grouped units into secondary cartons or boxes.
  • 4.2.2.3 Seal the cartons and label them appropriately.

4.3 Labeling

• 4.3.1 Verify the accuracy of all labels against the approved label copy.
• 4.3.2 Affix labels to the individual packages and secondary cartons as per the labeling instructions.
• 4.3.3 Inspect the labeled packages for legibility and correctness.

4.4 Final Inspection

• 4.4.1 Conduct a final inspection of the packaged units for compliance with specifications.
• 4.4.2 Document the inspection results in the packaging record.
• 4.4.3 Approve the packaged batch for release or document any deviations.

4.5 Documentation

• 4.5.1 Complete the batch packaging record with all relevant details.
• 4.5.2 Retain samples of the packaged product as per retention policy.
• 4.5.3 Archive all packaging records as per regulatory requirements.

5) Abbreviations, if any

None

6) Documents, if any

Batch Packaging Record
Label Copy Approval

7) Reference, if any

21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
EU GMP Annex 15 – Qualification and Validation

8) SOP Version

Version 1.0