Standard Operating Procedure for Label Printing and Verification for Tablet Packaging
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/237/2025 |
| Supersedes | SOP/TAB/237/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/04/2026 |
| Effective Date | 06/04/2026 |
| Review Date | 01/04/2027 |
1. Purpose
This SOP provides a systematic approach for the label printing and verification process during tablet packaging. It ensures that all packaging labels are correctly printed with accurate information, and that the labels are properly verified before the final packaging of the product.
2. Scope
This SOP applies to all tablet products that are packaged in blister packs, bottles, or other packaging formats. It covers the process of printing and verifying labels for both primary and secondary packaging.
3. Responsibilities
- Production Manager: Ensures that the labeling process follows this SOP and that equipment is functioning correctly.
- Labeling Operator: Operates the labeling equipment, ensures the labels are applied correctly, and verifies that the labels are accurate.
- Quality Control (QC) Inspector: Inspects labels for accuracy and legibility, verifies compliance with specifications, and addresses any discrepancies.
- Maintenance Personnel: Ensures that the printing equipment is maintained and calibrated regularly to prevent defects.
4. Accountability
The Production Manager is accountable for ensuring compliance with this SOP during the label printing and verification process. The QC department is responsible for verifying label accuracy and taking corrective actions in case of discrepancies.
5. Procedure
5.1 Preparation for Label Printing
- Ensure that the labeling machine is clean, calibrated, and ready for use (Annexure-1).
- Verify that the correct batch of labels is available for printing and is matched with the correct packaging specifications (Annexure-2).
- Check that the printing equipment is stocked with the appropriate inks, and that they are within their usage limits (Annexure-3).
- Verify that the required artwork files for the labels are approved and available for use (Annexure-4).
5.2 Label Printing Process
- Load the appropriate label stock into the labeling machine.
- Start the printing process and monitor the quality of the print, ensuring that the text and graphics are clear, legible, and free from defects (Annexure-5).
- Verify that the printed labels contain the correct batch number, expiry date, and all regulatory information as per product specifications (Annexure-6).
- Perform a test print every 30 minutes to ensure consistent print quality and adjust settings as needed (Annexure-7).
5.3 Label Verification
- After printing, visually inspect the labels for correct information, such as batch number, expiry date, and any mandatory warnings or regulatory information (Annexure-8).
- Verify label legibility and alignment on the packaging, ensuring there are no smudges, tears, or other defects (Annexure-9).
- Perform a peel test on a sample of the printed labels to ensure proper adhesion to the packaging (Annexure-10).
- Check for any misalignment of labels during the application process. Adjust the machine settings if necessary (Annexure-11).
- If any discrepancies are found, immediately stop the packaging process and take corrective actions (Annexure-12).
5.4 Corrective Actions for Labeling Issues
- If any errors are found during the verification process, document the issue in the label defect log (Annexure-13).
- Rework or discard defective products, and reprint the labels as required (Annexure-14).
- Investigate the root cause of the issue, whether it is related to the printing equipment, label stock, or operator error (Annexure-15).
- Implement corrective actions and test the labeling process again to ensure quality (Annexure-16).
5.5 Final Packaging and Approval
- Once the labels are verified and deemed acceptable, proceed with the final packaging of the product (Annexure-17).
- Ensure that the batch record for the packaging process is completed, signed, and filed for future reference (Annexure-18).
- Submit the batch for final approval and release by the QA department (Annexure-19).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- GMP: Good Manufacturing Practice
7. Documents
- Labeling Material Specifications (Annexure-1)
- Label Artwork Approval (Annexure-2)
- Label Stock Inventory Log (Annexure-3)
- Label Artwork Files (Annexure-4)
- Label Printing Inspection Log (Annexure-5)
- Label Verification Log (Annexure-6)
- Defective Label Log (Annexure-7)
- Label Adhesion Test Log (Annexure-8)
- Label Alignment Inspection Log (Annexure-9)
- Label Defect Report (Annexure-10)
- Corrective Action Log (Annexure-11)
- Batch Record (Annexure-12)
- Labeling Defect Log (Annexure-13)
- Label Rework Log (Annexure-14)
- Root Cause Analysis Report (Annexure-15)
- Packaging Approval Log (Annexure-16)
- Final Packaging Approval Log (Annexure-17)
- QA Batch Approval Log (Annexure-18)
- Packaging Batch Record (Annexure-19)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- USP <1079> – Good Storage and Distribution Practices
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Labeling Material Specifications
| Material | Specification | Supplier |
|---|---|---|
| Blister Foil | Aluminum foil with PVC backing | PackTech Ltd. |
Annexure-2: Label Artwork Approval
| Artwork Version | Approval Date | Approved By |
|---|---|---|
| Version 1.0 | 01/04/2026 | Jane Smith |