Standard Operating Procedure for Labeling Machines
1) Purpose
The purpose of this SOP is to provide guidelines for the operation and maintenance of labeling machines used in the manufacturing of dental dosage forms to ensure accurate labeling and compliance with regulatory standards.
2) Scope
This SOP applies to all labeling machines used in the manufacturing process of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Production Department is responsible for operating and cleaning the labeling machines. The Quality Assurance (QA) Department is responsible for verifying and documenting compliance with this SOP.
4) Procedure
4.1 Preparation
4.1.1 Verify that the labeling machine is clean and in good working condition before use.
4.1.2 Ensure all containers or packages to be labeled are ready and positioned correctly.
4.2 Setup and Calibration
4.2.1 Set up the labeling machine as per the manufacturer’s instructions and batch record requirements.
4.2.2 Calibrate the labeling machine to ensure accurate placement and adherence of labels.
4.2.3 Verify label placement and adherence with sample tests as per the batch record.
4.3 Labeling Operation
4.3.1 Load containers or packages into the labeling machine feeder system.
4.3.2 Start the labeling machine and adjust settings for label placement, speed, and alignment.
4.3.3 Monitor the labeling process to ensure accurate placement and adherence of labels.
4.3.4
4.4 Inspection and Verification
4.4.1 Inspect labeled containers or packages for correct labeling information, alignment, and legibility.
4.4.2 Perform verification checks to ensure all required information is present and accurate.
4.5 Cleaning
4.5.1 After use, turn off the labeling machine and disconnect it from the power source.
4.5.2 Disassemble parts of the labeling machine and clean all contact surfaces using approved cleaning agents.
4.5.3 Rinse thoroughly with purified water to remove any residual cleaning agents.
4.5.4 Inspect the labeling machine for cleanliness and reassemble it after it is completely dry.
4.6 Maintenance
4.6.1 Perform regular preventive maintenance on the labeling machine as per the manufacturer’s guidelines.
4.6.2 Record all maintenance activities in the equipment maintenance log.
5) Abbreviations, if any
QA – Quality Assurance
6) Documents, if any
Batch Record
Equipment Maintenance Log
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
8) SOP Version
Version 1.0
