Standard Operating Procedure for Labeling Process

Purpose

The purpose of this SOP is to establish procedures for the accurate and controlled labeling of pharmaceutical products, ensuring compliance with regulatory standards, and maintaining product traceability.

Scope

This SOP applies to all personnel involved in the labeling process, including operators, technicians, and quality control personnel.

Responsibilities

• Operators: Responsible for executing the labeling process according to the established procedures.
• Technicians: Responsible for monitoring and maintaining labeling equipment to ensure proper functionality.
• Quality Control Personnel: Responsible for monitoring and ensuring compliance with the labeling SOP.

Procedure

1. Inspect the labeling equipment for any visible damage or defects before each use.
2. Ensure that the equipment is clean, free from residues, and calibrated before starting the labeling process.
3. Verify that all labels, including product information, batch numbers, and expiration dates, are approved for use.
4. Load the labeling machine with the appropriate labels and set up the machine according to the approved specifications.
5. Verify that the product information matches the approved label content, including the correct product name, strength, and dosage form.
6. Initiate the labeling process and monitor the machine to ensure accurate label placement and adherence to specified parameters.
7. Perform periodic checks on labeled products to ensure the correct placement of labels and overall label quality.
8. If adjustments to the labeling parameters are necessary, document