injectable vials processed within the packaging area of the sterile injectable manufacturing facility. It covers vial crimping/sealing and labeling using automatic or semi-automatic machines.

3. Responsibilities

• Production Operator: Responsible for performing vial sealing and labeling activities as per SOP.
• Packaging Supervisor: Responsible for supervision, equipment readiness, and batch documentation.
• QA Officer: Responsible for in-process checks, verification of label accuracy, and line clearance.

4. Accountability

The Head of Manufacturing is accountable for ensuring compliance with this SOP and for the integrity of sealed and labeled injectable vials.

5. Procedure

5.1 Preparation for Sealing

1. Ensure the sealing/crimping machine is cleaned and line clearance is obtained (refer Annexure-1).
2. Verify that rubber stoppers are properly positioned on each vial before sealing.
3. Feed the aluminum flip-off seals into the hopper of the sealing machine.
4. Perform trial sealing on 5 vials and get QA verification on integrity and appearance.

5.2 Vial Sealing Operation

1. Start the machine and observe that:
   • Caps are crimped securely and uniformly.
   • No loose or tilted caps are visible.
2. Discard any vials with defective sealing.
3. Check sealing pressure periodically to ensure proper crimping.
4. Document sealing operations in the batch record.

5.3 Preparation for Labeling

1. Ensure correct labels (batch specific) are available and match with approved artwork.
2. Verify label information: product name, strength, batch number, Mfg/Exp dates, and regulatory info.
3. Perform trial labeling on 5 vials and get QA approval before bulk labeling.

5.4 Vial Labeling Operation

1. Load vials and labels into the labeling machine (automatic or semi-automatic as applicable).
2. Monitor that:
   • Labels are aligned correctly and firmly attached.
   • No overlaps, wrinkles, or missing labels.
3. Periodically inspect labeled vials as per sampling plan.
4. Rejected labels or vials must be documented and destroyed under QA supervision.

5.5 Post Operation

1. Reconcile used and unused labels (Annexure-2).
2. Clean labeling and sealing machines as per SOP.
3. Record completion of sealing and labeling in the Batch Packaging Record (BPR).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BPR: Batch Packaging Record
• GMP: Good Manufacturing Practices

7. Documents

1. Line Clearance Checklist – Annexure-1
2. Label Usage & Reconciliation Log – Annexure-2
3. Packaging Operation Log – Annexure-3

8. References

• WHO GMP Guide – Labeling and Packaging
• ICH Q8 – Pharmaceutical Development
• 21 CFR Part 211.125 – Labeling Control

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: Line Clearance Checklist

Area	Checked By	Date	Remarks
Labeling Line	Sunita Reddy	18/06/2025	No leftover labels

Annexure-2: Label Usage & Reconciliation Log

Batch No.	Labels Issued	Used	Rejected	Returned	Verified By
INJ-B144	5000	4900	50	50	Ravi Patel

Annexure-3: Packaging Operation Log

Batch No.	Operation	Date	Operator	Remarks
INJ-B144	Sealing & Labeling	18/06/2025	Ajay Mehra	Completed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
03/04/2022	1.0	Initial release	New SOP	Head QA
18/06/2025	2.0	Updated format, annexures, labeling checks	Annual review	Head QA