Tablets: SOP for Ensuring Tamper-Evident Sealing in Packaging – V 2.0
Standard Operating Procedure for Ensuring Tamper-Evident Sealing in Packaging
| Department |
Tablet |
| SOP No. |
SOP/TAB/250/2025 |
| Supersedes |
SOP/TAB/250/2022 |
| Page No. |
Page 1 of 6 |
| Issue Date |
01/07/2026 |
| Effective Date |
06/07/2026 |
| Review Date |
01/07/2027 |
1. Purpose
The purpose of this SOP is to define the process for ensuring the application of tamper-evident seals on all packaged tablets, ensuring the integrity and safety of the products. The tamper-evident seal prevents unauthorized access and helps maintain product quality, meeting both regulatory and customer requirements.
2. Scope
This SOP applies to all tamper-evident sealing processes for tablet packaging at the facility, including the application of tamper-evident seals on blister packs, bottles, and other packaging materials as required by the product specifications.
3. Responsibilities
- Packaging Operators: Responsible for the correct application of tamper-evident seals, ensuring that the packaging is securely sealed and free from any defects.
- Quality Control (QC): Responsible for inspecting packaging for the proper application of tamper-evident seals and verifying compliance with regulatory standards.
- Production Manager: Ensures that tamper-evident sealing is performed according to the SOP and investigates any discrepancies or failures in the process.
4. Accountability
The Production Manager is accountable for ensuring that the tamper-evident sealing procedure is followed correctly, while the QC team ensures compliance and conducts final inspections of tamper-evident seals.
5. Procedure
5.1 Preparation for Sealing
- Ensure that all packaging materials, including blister packs, bottles, and tamper-evident sealing components, are ready and compliant with the approved specifications (Annexure-1).
- Check that the sealing machine is properly set up and calibrated according to the manufacturer’s guidelines (Annexure-2).
- Verify that the correct batch and product information are included in the packaging material before sealing (Annexure-3).
5.2 Applying the Tamper-Evident Seal
- Place the blister packs or bottles into the tamper-evident sealing machine and initiate the sealing process (Annexure-4).
- Ensure that the tamper-evident seal is applied correctly, with no signs of tampering or misalignment (Annexure-5).
- For blister packaging, ensure the seal adheres tightly to the cavity, preventing any unauthorized access (Annexure-6).
- For bottles, verify that the seal is firmly applied to the neck of the bottle and covers the cap securely (Annexure-7).
- If any seals are damaged, remove the affected package from the production line and reapply the seal or discard the package as necessary (Annexure-8).
5.3 Verification and Inspection
- QC personnel must inspect a sample of each batch to ensure the tamper-evident seals are correctly applied and intact (Annexure-9).
- Verify the seals for any signs of tampering, damage, or improper application (Annexure-10).
- If any defective seals are found, initiate corrective actions and rework the affected packages (Annexure-11).
5.4 Final Inspection and Documentation
- After the tamper-evident seal application, conduct a final inspection to confirm that all packages meet the packaging and regulatory standards (Annexure-12).
- Complete the Tamper-Evident Seal Inspection Log for each batch (Annexure-13) and store it for future reference.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- FDA: Food and Drug Administration
- EMA: European Medicines Agency
7. Documents
- Packaging Material Log (Annexure-1)
- Sealing Machine Calibration Log (Annexure-2)
- Batch and Product Information Log (Annexure-3)
- Sealing Machine Setup Log (Annexure-4)
- Blister Pack Seal Inspection Log (Annexure-5)
- Bottle Seal Inspection Log (Annexure-6)
- Seal Integrity Inspection Log (Annexure-7)
- Damaged Seal Report (Annexure-8)
- Tamper-Evident Seal Inspection Log (Annexure-9)
- Seal Defect Report (Annexure-10)
- Corrective Action Log (Annexure-11)
- Final Inspection Log (Annexure-12)
- Tamper-Evident Seal Records Retention Log (Annexure-13)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- USP <1079> – Good Storage and Distribution Practices
- ISO 9001 – Quality Management Systems
9. SOP Version
Version: 2.0
10. Approval Section
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Checked By |
Approved By |
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11. Annexures
Annexure-1: Packaging Material Log
| Material Type |
Batch Number |
Quantity |
Received Date |
| Blister Packs |
Batch 12345 |
1000 |
01/07/2026 |
Annexure-2: Sealing Machine Calibration Log
| Machine ID |
Calibration Date |
Operator |
Calibration Status |
| Sealer 001 |
01/07/2026 |
John Doe |
Passed |
Annexure-3: Batch and Product Information Log
| Batch Number |
Product Name |
Quantity |
Packaging Date |
| Batch 12345 |
Chewable Tablets |
1000 |
01/07/2026 |
| Batch 12346 |
Dispersible Tablets |
2000 |
02/07/2026 |
Annexure-4: Sealing Machine Setup Log
| Machine ID |
Setup Date |
Operator |
Setup Status |
| Sealer 001 |
01/07/2026 |
John Doe |
Completed |
| Sealer 002 |
02/07/2026 |
Jane Smith |
Completed |
Annexure-5: Blister Pack Seal Inspection Log
| Batch Number |
Inspection Date |
Inspector |
Status |
| Batch 12345 |
01/07/2026 |
John Doe |
Pass |
| Batch 12346 |
02/07/2026 |
Jane Smith |
Pass |
Annexure-6: Bottle Seal Inspection Log
| Batch Number |
Inspection Date |
Inspector |
Status |
| Batch 12345 |
01/07/2026 |
John Doe |
Pass |
| Batch 12346 |
02/07/2026 |
Jane Smith |
Pass |
Annexure-7: Seal Integrity Inspection Log
| Batch Number |
Inspection Date |
Inspector |
Seal Status |
| Batch 12345 |
01/07/2026 |
Jane Smith |
Intact |
| Batch 12346 |
02/07/2026 |
John Doe |
Intact |
Annexure-8: Damaged Seal Report
| Batch Number |
Damage Type |
Corrective Action |
Reported By |
| Batch 12345 |
Misalignment |
Reapply seal |
Jane Smith |
| Batch 12346 |
Seal cut |
Repackaged and sealed |
John Doe |
Annexure-9: Tamper-Evident Seal Inspection Log
| Batch Number |
Inspection Date |
Inspector |
Seal Status |
| Batch 12345 |
01/07/2026 |
John Doe |
Pass |
| Batch 12346 |
02/07/2026 |
Jane Smith |
Pass |
Annexure-10: Seal Defect Report
| Batch Number |
Defect Type |
Corrective Action |
Reported By |
| Batch 12345 |
Seal not applied properly |
Reapplied and checked |
Jane Smith |
| Batch 12346 |
Seal damaged |
Repacked and resealed |
John Doe |
Annexure-11: Corrective Action Log
| Issue |
Action Taken |
Responsible Person |
Action Date |
| Seal misalignment |
Reapplied the tamper-evident seal |
John Doe |
01/07/2026 |
Annexure-12: Final Inspection Log
| Batch Number |
Inspection Date |
Inspector |
Status |
| Batch 12345 |
01/07/2026 |
John Doe |
Pass |
| Batch 12346 |
02/07/2026 |
Jane Smith |
Pass |
Annexure-13: Tamper-Evident Seal Records Retention Log
| Document Type |
Retention Period |
Stored By |
Storage Location |
| Tamper-Evident Seal Records |
5 years |
John Doe |
Storage Area B |
13. Revision History:
| Revision Date |
Revision No. |
Revision Details |
Reason for Revision |
Approved By |
| 01/01/2024 |
1.0 |
Initial SOP creation |
New procedure |
QA Head |
| 01/07/2026 |
2.0 |
Updated sealing procedure and added logs for tamper-evident seal checks |
Updated regulatory requirements and process improvements |
QA Head |