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 the changes made and the reason for the adjustments.
9. Perform in-process checks, such as visual inspections and barcode scanning, to assess the quality of labeled products.
10. Collect samples for quality control testing, including label content verification and barcode readability.
11. Submit samples to the quality control laboratory, ensuring that the labeled products meet the predefined acceptance criteria.
12. If the products pass quality control, proceed with further processing steps as per the formulation requirements.
13. If the products fail quality control, initiate an investigation, document the findings, and implement corrective actions as needed.
14. Complete the logbook or batch record with all pertinent information, including any adjustments made during the labeling process.
15. Clean and sanitize the labeling equipment regularly according to the approved cleaning procedures.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Labeling Logbook
• Quality Control Test Results
• Maintenance and Calibration Records
• Deviation and Corrective Action Logs

Reference

FDA Code of Federal Regulations – Title 21

SOP Version

Version 1.0