Standard Operating Procedure for Inkjet or Laser Coding Process

Purpose

The purpose of this SOP is to establish procedures for the accurate and consistent coding of pharmaceutical products using inkjet or laser coding technology, ensuring compliance with regulatory standards and product traceability.

Scope

This SOP applies to all personnel involved in the inkjet or laser coding process, including operators, technicians, and quality control personnel.

Responsibilities

• Operators: Responsible for setting up and operating the inkjet or laser coding equipment according to established procedures.
• Technicians: Responsible for monitoring and maintaining coding equipment to ensure proper functionality.
• Quality Control Personnel: Responsible for verifying the accuracy and quality of coded products through inspections and testing.

Procedure

1. Inspect the inkjet or laser coding equipment for any visible damage or defects before each use.
2. Ensure that the equipment is clean, free from residues, and calibrated before starting the coding process.
3. Verify the accuracy of the code to be applied, including batch numbers, expiration dates, and any other required information.
4. Load the product into the coding area, ensuring proper alignment and spacing for accurate coding.
5. Set up the coding parameters (position, size, font, etc.) as specified in the approved coding procedure.
6. Initiate the coding process and monitor the equipment to ensure clear and accurate code application.
7. Perform periodic checks on coded products to