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