Standard Operating Procedure Operation of Label Inspection System

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the proper operation of a label inspection system in pharmaceutical manufacturing. This ensures accurate and consistent inspection of labels on product containers for defects and quality control while maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the operation of label inspection systems within the pharmaceutical manufacturing facility.

3. Responsibilities

• System Operator: Responsible for following the procedures outlined in this SOP during system operations.
• Supervisor: Oversees and verifies compliance with this SOP, including training and documentation.

4. Procedure

4.1. Pre-Operation Checks

1. Inspect the label inspection system for any visible damage, malfunctions, or defects. Report any issues to the supervisor.
2. Ensure that the system is clean and free from any residues or contaminants from previous operations.
3. Verify that all necessary utilities (e.g., electricity, lighting) are available and functioning properly.

4.2. Set-Up

1. Position the label inspection system in the designated location for operation.
2. Adjust the system settings, including inspection criteria, label placement, and rejection criteria, according to the product specifications and batch record.
3. Calibrate the system as needed to ensure accurate label inspection.

4.3. Inspection Process

1. Start the label inspection system according to the manufacturer’s instructions and the parameters specified in the batch record.
2. Feed product containers with labels into the system’s conveyor or infeed system, ensuring they are properly oriented for inspection.
3. Monitor the inspection process closely to verify that labels are accurately and consistently inspected for defects.
4. Check for any defective labels, misplacements, or other deviations and take corrective action as necessary.
5. Record the inspection time, inspection criteria, and any deviations from the standard procedure.

4.4. Post-Inspection Checks

1. Stop the label inspection system when the inspection process is completed or as directed by the supervisor.
2. Perform visual inspections of the containers to verify the accuracy of label detection and quality control.
3. Segregate and label any containers with defective labels for further evaluation or re-labeling.

4.5. Cleaning and Maintenance

1. Clean the label inspection system and associated equipment after use, following the cleaning procedure.
2. Perform routine maintenance as per the manufacturer’s recommendations to ensure the system’s continued performance.

4.6. Documentation

Properly document all aspects of the label inspection system operation, including pre-operation checks, system settings, inspection parameters, and post-inspection checks. Maintain records in a secure and accessible location for regulatory inspection.

5. Abbreviations

• GMP: Good Manufacturing Practices

6. Reference

[Insert any relevant references or standards applicable to the operation of label inspection systems in the pharmaceutical industry.]

7. SOP Version

This is version 1.0 of the “Operation of Label Inspection System SOP,” issued on [insert issuance date].