processes of prefilled syringes during the secondary packaging operations at the Sterile Injection Manufacturing facility.

3. Responsibilities

• Packing Operator: Ensures correct application of tamper-evident seals during packaging.
• Line Supervisor: Verifies sealing operation and inspects sealing integrity.
• Quality Assurance (QA): Conducts in-process checks and documents compliance.
• Engineering: Maintains and calibrates sealing machines.

4. Accountability

The Head of Production is accountable for the implementation and compliance of this SOP. The Head of QA is accountable for final approval and audit readiness.

5. Procedure

5.1 Receiving and Preliminary Inspection

1. Receive tamper-evident labels or seals from the warehouse with accompanying CoA.
2. Check packaging materials for integrity, batch number, and expiry date.
3. Document receipt in the Tamper Seal Logbook (Annexure-1).

5.2 Verification of Sealing Materials

1. Verify that the tamper-evident seals match the approved artwork and specifications.
2. Cross-check the delivery against the packing batch record and Bill of Materials.
3. Ensure materials are released by QA before usage.

5.3 Machine Setup and Trial Run

1. Set sealing machine parameters as per validated batch protocol.
2. Perform a trial run of 10 units; inspect for alignment, adhesion, and legibility.
3. Get QA clearance for commencing full operation.

5.4 Tamper-Evident Sealing Process

1. Feed prefilled syringe packs into the automated sealing machine.
2. Ensure continuous monitoring of label roll placement and adhesive temperature.
3. Monitor critical parameters such as pressure, dwell time, and seal width.
4. Replace label rolls immediately upon detecting end-of-roll or misalignment.

5.5 In-Process Inspection

1. Inspect one unit every 15 minutes for seal placement, tamper visibility, and legibility.
2. Use a standard checklist (Annexure-2) to document visual checks.
3. In case of deviation, isolate affected units and notify QA.

5.6 Post-Operation Verification

1. Ensure all packs in the batch are sealed and intact before transferring to the shipper.
2. Document reconciliation of tamper seals used versus dispensed in Annexure-3.
3. Affix line clearance label and have it verified by QA.

5.7 Documentation and Record-Keeping

1. Maintain the Tamper Seal Logbook (Annexure-1).
2. Attach in-process inspection records and reconciliation sheets with the BPR.
3. QA shall review and archive records for traceability.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CoA: Certificate of Analysis
• BPR: Batch Packing Record

7. Documents

1. Tamper Seal Logbook – Annexure-1
2. Visual Inspection Checklist – Annexure-2
3. Seal Reconciliation Sheet – Annexure-3

8. References

• WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products
• 21 CFR Part 211 – Current Good Manufacturing Practice
• ICH Q8 – Pharmaceutical Development

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Tamper Seal Logbook

Date	Seal Batch No.	Quantity Received	Quantity Used	Balance	Checked By
24/06/2025	TS-PRF-305	10000	9800	200	Sunita Reddy

Annexure-2: Visual Inspection Checklist

Time	Seal Intact	Proper Placement	Operator Initials	QA Verified
09:15	Yes	Yes	Rajesh Kumar	Yes

Annexure-3: Seal Reconciliation Sheet

Batch No.	Seal Issued	Seal Used	Balance Returned	QA Verified
PF-2025-009	10000	9800	200	Yes

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/03/2022	1.0	Initial issue	New SOP	Head QA
24/06/2025	2.0	Added reconciliation and checklist procedures	Annual Review	Head QA