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
- Inspect the inkjet or laser coding equipment for any visible damage or defects before each use.
- Ensure that the equipment is clean, free from residues, and calibrated before starting the coding process.
- Verify the accuracy of the code to be applied, including batch numbers, expiration dates, and any other required information.
- Load the product into the coding area, ensuring proper alignment and spacing for accurate coding.
- Set up the coding parameters (position, size, font, etc.) as specified in the approved coding procedure.
- Initiate the coding process and monitor the equipment to ensure clear and accurate code application.
- Perform periodic checks on coded products to
ensure legibility and consistency.
If adjustments to the coding parameters are necessary, document the changes made and the reason for the adjustments.
Perform in-process quality control checks, including visual inspections and code verification using barcode scanners if applicable.
Collect samples for additional quality control testing, including readability testing and ink adhesion testing.
Submit samples to the quality control laboratory, ensuring that the coded products meet the predefined acceptance criteria.
If the coded products pass quality control, release them for further processing or packaging.
If the coded products fail quality control, initiate an investigation, document the findings, and implement corrective actions as needed.
Complete the logbook or batch record with all pertinent information, including any adjustments made during the coding process.
Clean and maintain the coding equipment regularly according to the approved cleaning procedures.
Abbreviations
No abbreviations are used in this SOP.
Documents
- Coding Logbook
- Quality Control Test Results
- Maintenance and Calibration Records
- Deviation and Corrective Action Logs
Reference
ISO 15415 – Bar code print quality test specification – Linear symbols
SOP Version
Version 1.0
