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
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
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 |