for primary and secondary packaging components (e.g., vial labels, carton labels, shipping labels) used for sterile injectable products in the manufacturing facility.

3. Responsibilities

• Packaging Supervisor: Responsible for initiating label printing and assigning authorized personnel.
• Label Operator: Responsible for printing, checking, and documenting label printing activities.
• QA Officer: Responsible for line clearance and verifying label content and reconciliation.

4. Accountability

The Head of Quality Assurance is accountable for ensuring compliance with the label printing and verification process outlined in this SOP.

5. Procedure

5.1 Preparation for Label Printing

1. Receive approved artwork and master copy from the Regulatory Affairs/Artwork team.
2. Ensure that the label printer is cleaned and cleared of any previously printed material.
3. Confirm the correct label format, strength, product code, and batch-specific data before initiating printing.

5.2 Label Printing Process

1. Log into the authorized label printing system with secured credentials.
2. Select the appropriate template based on product and packaging configuration.
3. Enter dynamic fields such as batch number, manufacturing date, expiry date, and product license number as applicable.
4. Print a minimum of three sample labels for QA verification before bulk printing.

5.3 Label Verification

1. QA Officer shall verify:
   • Legibility and alignment of printed information.
   • Correct font, spelling, and regulatory compliance of content.
   • Batch information correctness and barcode clarity.
2. Upon QA approval, authorize bulk label printing.

5.4 Label Reconciliation

1. At the end of each packaging batch, reconcile used, unused, and rejected labels.
2. Record label quantities in the Label Reconciliation Form (Annexure-1).
3. Destroy all rejected labels under QA supervision and document in the Label Destruction Log (Annexure-2).

5.5 Line Clearance and Control

1. Before each new batch, QA must perform line clearance and document in Line Clearance Record (Annexure-3).
2. Ensure no previous labels or printed materials are left in the packaging area.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• RA: Regulatory Affairs

7. Documents

1. Label Reconciliation Form – Annexure-1
2. Label Destruction Log – Annexure-2
3. Line Clearance Record – Annexure-3

8. References

• WHO GMP Guidelines for Pharmaceuticals
• ICH Q8, Q9, Q10 Guidelines
• 21 CFR Part 211 – Labeling Requirements

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: Label Reconciliation Form

Batch No.	Printed	Used	Rejected	Returned	Verified By
INJ-B123	5000	4800	100	100	Sunita Reddy

Annexure-2: Label Destruction Log

Date	Batch No.	Quantity Destroyed	Method	Destroyed By	Witnessed By
18/06/2025	INJ-B123	100	Shredding	Rajesh Kumar	Anjali Mehta

Annexure-3: Line Clearance Record

Batch No.	Area Checked	Cleared By	Date	Remarks
INJ-B123	Labeling Machine	Kiran Patel	18/06/2025	Area Clean

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
12/04/2022	1.0	Initial SOP release	New process implementation	Head QA
18/06/2025	2.0	Updated annexures, clarification on verification process	Annual review	Head QA