checking, and applying batch numbers during the labeling and packing process of sterile injectable products at the facility.

3. Responsibilities

• Packing Operator: Ensure batch numbers are correctly printed and verified on all packaging components.
• Packing Supervisor: Double-check batch number entries and conduct random visual checks.
• QA Officer: Perform in-process verification and document verification results.

4. Accountability

The Packaging Manager is accountable for ensuring that batch number verification is carried out according to this SOP and all deviations are investigated and reported.

5. Procedure

5.1 Pre-Operation Checks

1. Verify the issuance of correct batch number details from the BMR (Batch Manufacturing Record).
2. Ensure packaging lines are cleared and line clearance is obtained before initiating printing (refer Annexure-1).

5.2 Batch Number Printing

1. Use approved printers for applying batch numbers on:
   • Labels
   • Cartons
   • Tray Inserts
2. Test print on samples to confirm clarity, alignment, and legibility.
3. Ensure that the printed batch number format matches the batch record.

5.3 Online Verification

1. Designated operators shall perform 100% verification during online packaging.
2. Each carton or label must be checked visually for:
   • Correct batch number
   • Legible and smudge-free print
   • Correct placement

5.4 QA Verification

1. QA Officer to randomly select samples from each printed lot and verify:
2. Consistency with batch manufacturing records
3. Proper documentation of verified samples in Annexure-2

5.5 Handling of Errors or Mismatches

1. If incorrect batch numbers are identified:
   • Immediately segregate affected materials
   • Label as “Rejected”
   • Record in Batch Number Error Log (Annexure-3)
   • Inform QA and investigate root cause

5.6 Final Confirmation and Documentation

1. Before batch release, QA Head shall ensure that:
   • Verification records are complete
   • Discrepancies have been addressed
2. All records must be attached to the BPR (Batch Packaging Record).

6. Abbreviations

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

7. Documents

1. Line Clearance Record – Annexure-1
2. Batch Number Verification Log – Annexure-2
3. Batch Number Error Log – Annexure-3

8. References

• WHO TRS 1019 – Annex 6: GMP for Pharmaceutical Products
• 21 CFR Part 211 – Subpart G: Packaging and 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 Record

Area	Checked By	Date	Remarks
Packing Hall – Cartoning Line	Sunita Reddy	18/06/2025	Cleared for batch start

Annexure-2: Batch Number Verification Log

Batch No.	Packaging Component	Verified By	Date	Remarks
INJ-095	Carton	Ravi Deshmukh	18/06/2025	Verified OK
INJ-095	Label	Ravi Deshmukh	18/06/2025	Verified OK

Annexure-3: Batch Number Error Log

Date	Batch No.	Component	Issue	Disposition	Handled By
18/06/2025	INJ-095	Tray Insert	Misprint – batch missing	Rejected	Ajay Kumar

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
03/03/2022	1.0	Initial version	New SOP	Head QA
18/06/2025	2.0	Annexures added, verification log improved	GMP alignment	Head QA