Procedure for Validating Labeling Process in Aerosol Packaging

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for validating labeling operations in aerosol packaging. This ensures label accuracy, regulatory compliance, and prevention of mislabeling errors.

2. Scope

This SOP applies to all aerosol products that undergo labeling in the packaging department, covering printed labels, barcodes, batch codes, and expiration dates.

3. Responsibilities

• Packaging Operators: Responsible for applying and verifying labels during packaging.
• Quality Assurance (QA) Team: Responsible for reviewing labeling accuracy and ensuring compliance.
• Production Supervisor: Responsible for overseeing the labeling process.
• Regulatory Affairs Team: Responsible for approving label content and format.

4. Accountability

The Packaging Manager is accountable for ensuring the proper validation of labeling processes.

5. Procedure

5.1. Pre-Validation of Labeling

1. Ensure that label artwork has been reviewed and approved by the Regulatory Affairs team.
2. Cross-check label specifications with the Label Specification Document (Annexure-1).
3. Confirm that the label printing machine is calibrated.

5.2. Label Application Validation

1. Verify that the correct label roll is loaded into the labeling machine.
2. Conduct an initial validation run with five sample units.
3. Perform routine checks every 30 minutes during production.
4. Record validation results in the Label Application Validation Log