Standard Operating Procedure for Operation of Labeling Machine

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the proper operation of a labeling machine in pharmaceutical manufacturing. This ensures accurate and consistent labeling of product containers while maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the operation of labeling machines within the pharmaceutical manufacturing facility.

3. Responsibilities

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

4. Procedure

4.1. Pre-Operation Checks

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

4.2. Set-Up

1. Position the labeling machine in the designated location for operation.
2. Load the label rolls or sheets, ensuring they are properly aligned with the labeling head and securely attached to the machine.
3. Adjust the machine settings, including label placement and alignment, according to the product specifications and batch record.

4.3. Labeling Process

1. Start the labeling machine according to the manufacturer’s instructions and the parameters specified in the batch record.
2. Ensure that the machine is set to the correct label placement and alignment for the product containers.
3. Monitor the labeling process closely to verify that labels are applied accurately and securely to the containers.
4. Check for any misfeeds, jams, or improperly labeled containers and take corrective action as necessary.
5. Record the labeling time, labeling speed, and any deviations from the standard procedure.

4.4. Post-Labeling Checks

1. Stop the labeling machine when the labeling process is completed or as directed by the supervisor.
2. Perform visual inspections of the labeled containers to ensure proper label placement, adhesion, and alignment.
3. Verify that container labels, lot numbers, and expiration dates are accurate and legible.

4.5. Cleaning and Maintenance

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

4.6. Documentation

Properly document all aspects of the labeling machine operation, including pre-operation checks, machine settings, labeling parameters, and post-labeling 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 labeling machines in the pharmaceutical industry.]

7. SOP Version

This is version 1.0 of the “Operation of Labeling Machine SOP,” issued on [insert issuance date].