Labeling Verification Procedures

1) Purpose

The purpose of this SOP is to establish a standardized procedure for verifying that all labels are accurate, legible, and compliant with regulatory requirements.

2) Scope

This SOP applies to all labeling activities within the pharmaceutical manufacturing facility.

3) Responsibilities

– QC personnel are responsible for conducting labeling verification.
– Production personnel must provide samples of labeled products for verification.
– QA personnel are responsible for reviewing and approving the verification results.

4) Procedure

1. Label Design and Approval
1.1. Ensure that all label designs are approved by the QA department before printing.
1.2. Verify that label designs comply with regulatory requirements and internal standards.
2. Label Printing
2.1. Use approved printing equipment and materials for label production.
2.2. Ensure that all printed labels are clear, legible, and free from defects.
2.3. Perform a test print and inspect for accuracy before commencing full-scale printing.
3. Label Verification
3.1. Collect a representative sample of labels from each batch of printed labels.
3.2. Inspect each label for:
3.2.1. Accuracy of information (e.g., product name, batch number, expiration date)
3.2.2. Legibility and clarity of text and graphics
3.2.3. Proper placement and alignment
3.2.4. Absence of smudges, blurs, or other defects
4. Verification of Labeled Products
4.1. Collect a representative sample of labeled products from each production batch.
4.2. Verify that the labels on the products match the approved label design and are correctly applied.
4.3. Check for proper adhesion of labels and absence of wrinkles or bubbles.
5. Documentation
5.1. Record all label verification results on the labeling verification form.
5.2. Include details such as batch number, date of verification, and any observations or anomalies.
5.3. Sign and date the verification form.
6. Acceptance and Rejection
6.1. Accept labels and labeled products if they meet all specified criteria.
6.2. Reject labels and labeled products if they show signs of inaccuracies or defects.
6.3. Notify the label printing department of any rejected labels and document the rejection.
7. Review and Approval
7.1. Submit the completed verification forms to the QA department for review.
7.2. QA will review and approve the results based on the criteria outlined in this SOP.
8. Corrective Actions
8.1. If labels or labeled products are rejected, initiate a corrective action report.
8.2. Document all actions taken to address issues identified during the verification, including potential adjustments to the labeling process.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance

6) Documents, if any

– Labeling Verification Form
– Corrective Action Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– USP <7> Labeling

8) SOP Version

Version 1.0