Standard Operating Procedure for Labeling Control System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for the control and management of labeling in the manufacturing of ocular dosage forms to ensure accuracy, consistency, and compliance with regulatory requirements.

2) Scope

This SOP applies to all labeling activities related to ocular dosage forms, including but not limited to the design, printing, application, and verification of labels for raw materials, intermediate products, and finished products.

3) Responsibilities

Labeling managers, quality control personnel, and production staff are responsible for implementing and maintaining compliance with this SOP. All employees involved in labeling activities must adhere to the procedures and practices outlined.

4) Procedure

4.1 Label Design and Approval

1. Develop label designs using approved templates and formats, ensuring all required information is included.
2. Submit label designs for review and approval by authorized personnel, including quality assurance and regulatory affairs.
3. Assign unique identification numbers to each label design for tracking and control purposes.

4.2 Label Printing and Verification

1. Print labels using approved printers and materials, ensuring clarity and durability.
2. Verify printed labels against approved designs to ensure accuracy and compliance with specifications.
3. Document any discrepancies and take corrective actions as needed.

4.3 Label Application

1. Apply labels to raw materials, intermediate products, and finished products according to approved procedures.
2. Ensure labels are applied correctly and securely, without wrinkles, bubbles, or misalignment.
3. Inspect labeled items to confirm proper application and readability of information.

4.4 Label Storage and Handling

1. Store unused labels in a controlled environment to prevent damage, loss, or unauthorized access.
2. Handle labels carefully to avoid contamination, damage, or loss of adhesive properties.
3. Implement inventory control measures for label stock, including regular audits and reconciliations.

4.5 Labeling Documentation and Records

1. Maintain records of label designs, approvals, and printing activities.
2. Document label application activities, including batch numbers, quantities, and dates.
3. Retain labeling records for the required duration according to regulatory and company policies.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

1. Label design records
2. Label printing logs
3. Label application records

7) Reference, if any

Good Manufacturing Practice (GMP) guidelines for pharmaceutical manufacturing

8) SOP Version

Version 1.0