including vials, ampoules, prefilled syringes, and other sterile dosage forms requiring tamper-evident seals or indicators.

3. Responsibilities

• Packaging Operator: Ensures tamper-evident materials are applied correctly during packaging operations.
• IPQA Officer: Monitors and verifies the integrity of tamper-evident features on each batch.
• Quality Control: Inspects random samples for seal integrity and adherence to specifications.

4. Accountability

The Packaging Manager is accountable for ensuring all injectable products are packed with appropriate tamper-evident mechanisms as per regulatory expectations.

5. Procedure

5.1 Types of Tamper-Evident Features

1. Use of flip-off seals for vials with distinct color-coding for each product strength.
2. Aluminum crimping with breakable evidence for ampoules.
3. Pre-attached plastic break-away caps for prefilled syringes.
4. Security holograms or tamper-indicating stickers on secondary cartons.

5.2 Material Inspection

1. Inspect tamper-evident components upon receipt for visual defects, labeling accuracy, and quantity.
2. Ensure all incoming packaging components bear batch numbers and are stored separately as per SOP/SIM/096/2025.

5.3 Application in Primary Packaging

1. During the filling and sealing process, ensure that:
   • Flip-off seals are applied uniformly and pressed firmly.
   • Breakable ampoule necks are flame-sealed accurately.
   • Syringes are capped with pre-tensioned tamper-proof caps.
2. Packaging line in-process checks must verify 100% application of seals and alignment.

5.4 Secondary Packaging Verification

1. Verify holograms or stickers are positioned as per packaging artwork on each carton.
2. IPQA must inspect random samples from every batch to confirm seal integrity and tamper-evidence visibility.

5.5 Defect Management

1. Any product with misaligned, damaged, or missing tamper seals shall be rejected and recorded in the deviation log (Annexure-2).
2. Defective materials shall be stored in a designated area and disposed of as per SOP/QC/REJ/011.

5.6 Training and Awareness

1. All personnel involved in packaging shall be trained annually on tamper-evident features and visual inspection techniques.
2. Training records to be maintained (Annexure-3).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• IPQA: In-Process Quality Assurance
• QC: Quality Control

7. Documents

1. Tamper-Evident Component Receipt Log – Annexure-1
2. Deviation Log – Annexure-2
3. Training Record – Annexure-3

8. References

• 21 CFR Part 211.132 – Tamper-evident packaging requirements for over-the-counter (OTC) human drug products
• EU GMP Guidelines – Annex 16: Certification by a Qualified Person
• WHO TRS 986 Annex 2 – GMP Guidelines for Pharmaceutical Products

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-Evident Component Receipt Log

Date	Material	Batch No.	Qty	Received By
15/06/2025	Flip-off seals (Red)	FOS-1023	20,000	Rajesh Kumar

Annexure-2: Deviation Log

Date	Batch No.	Description of Deviation	Corrective Action	Approved By
16/06/2025	INJ-097	10 cartons missing hologram	Line rechecked and replaced	Sunita Reddy

Annexure-3: Training Record

Employee Name	Department	Training Date	Trainer	Status
Ajay Verma	Packaging	10/06/2025	QA Officer	Completed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/04/2022	1.0	Initial version	New SOP	Head QA
18/06/2025	2.0	Included secondary packaging hologram inspection	Periodic review	Head QA