and secondary label printing, review, approval, and verification activities carried out in the sterile injectable manufacturing and packaging departments.

3. Responsibilities

• Packaging Operator: Responsible for printing labels as per batch requirements and specifications.
• QA Officer: To verify label accuracy, documentation, and reconciliation.
• Production Supervisor: To authorize and oversee label printing process.

4. Accountability

The Head of Quality Assurance is accountable for ensuring label printing and verification is carried out as per SOP, and any deviations are documented and investigated appropriately.

5. Procedure

5.1 Preparation for Label Printing

1. Receive approved artwork and label specifications from QA/Regulatory Affairs.
2. Ensure label printer is validated and calibrated.
3. Use blank labels stored in controlled conditions, ensuring batch segregation.
4. Record issuance of blank labels in Label Issuance Log (Annexure-1).

5.2 Label Printing

1. Login to the label printing software with authorized credentials.
2. Select correct label template based on product name, strength, dosage form, and pack size.
3. Enter batch number, manufacturing date, expiry date, and product code as per BMR.
4. Print a test label and get it verified by QA before bulk printing.
5. Print labels as per batch size, including overages as per approved policy.

5.3 Label Verification

1. QA personnel shall cross-verify 100% of the first 10 printed labels for accuracy.
2. Random sampling (minimum 10%) of the remaining labels shall be done for quality check.
3. Label Verification Record (Annexure-2) shall be filled and signed.
4. Defective or excess labels must be recorded and destroyed as per SOP/SIM/096/2025.

5.4 Label Reconciliation and Storage

1. At end of batch, unused labels must be counted, recorded, and destroyed in QA presence.
2. Update the Label Reconciliation Log (Annexure-3).
3. Ensure batch-specific segregation to avoid mix-up risks.
4. Store labels securely until use or destruction.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record

7. Documents

1. Label Issuance Log – Annexure-1
2. Label Verification Record – Annexure-2
3. Label Reconciliation Log – Annexure-3

8. References

• WHO GMP Guidelines – Labeling of Pharmaceutical Products
• ICH Q8 – Pharmaceutical Development
• 21 CFR 211.122 – 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 Issuance Log

Date	Batch No.	Product	Label Qty Issued	Issued By
18/06/2025	INJ/0923	Ceftriaxone Injection	10,500	Rajesh Kumar

Annexure-2: Label Verification Record

Label Type	Batch No.	Verified Items	Status	Checked By
Primary	INJ/0923	Batch No., Mfg. Date, Exp. Date	Correct	Sunita Reddy

Annexure-3: Label Reconciliation Log

Batch No.	Issued	Used	Returned	Destroyed	Remarks
INJ/0923	10,500	10,000	300	200	As per SOP

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
20/04/2022	1.0	Initial version	New SOP	QA Head
18/06/2025	2.0	Improved QA verification protocol	Annual review	QA Head