final labeling and batch coding in the Packaging Department before packing and dispatch.

3. Responsibilities

• Packaging Operators: Perform labeling and batch coding operations as per SOP.
• Packaging Supervisors: Ensure proper setup of machines, verification of printed data, and documentation.
• QA Personnel: Verify label reconciliation, inspect printed output, and ensure compliance with approved batch records.

4. Accountability

The Packaging Head is accountable for implementation of this SOP and ensuring error-free labeling and coding of all injectable vials.

5. Procedure

5.1 Preparation

1. Ensure that the labeling area is clean and labeled as per status.
2. Verify the availability of approved labels from QA.
3. Collect labeling instructions and batch details from the Batch Packaging Record (BPR).
4. Cross-verify the following on labels:
   • Product name
   • Strength and volume
   • Batch number
   • Mfg. and Exp. dates
   • MRP and storage conditions

5.2 Labeling Operation

1. Set up the labeling machine according to vial size and label dimensions.
2. Perform label roll loading, ensuring direction and alignment is correct.
3. Conduct label print trial and get it approved by QA before starting bulk labeling.
4. Operate the machine to label vials with proper adhesion, ensuring:
   • No wrinkles, air bubbles, or misplacement
   • 100% readability and proper orientation

5.3 Batch Coding Operation

1. Set up the coding device (e.g., inkjet, thermal transfer) for batch number, Mfg. and Exp. date printing.
2. Conduct trial printing on dummy labels and get QA approval.
3. Start batch coding process after QA clearance.
4. Inspect printed output for:
   • Clarity and legibility
   • Correct alignment
   • No smudging or faded text
5. Document coding verification in the BPR.

5.4 In-Process Checks

1. Every 30 minutes, verify labeled and coded vials for:
   • Correct batch number and date
   • Defect-free labeling
2. QA to inspect 1% of labeled vials from each lot.

5.5 Reconciliation and Documentation

1. Count and reconcile issued vs. used labels and coded vials.
2. Record unused labels and send them back to QA for destruction.
3. Complete the Label Reconciliation Sheet (Annexure-1).
4. Sign off on batch labeling activity in the BPR.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BPR: Batch Packaging Record
• MRP: Maximum Retail Price

7. Documents

1. Label Reconciliation Sheet – Annexure-1
2. Batch Coding Verification Log – Annexure-2

8. References

• WHO GMP Guidelines for Packaging
• Schedule M – Drugs and Cosmetics Act

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Packaging Executive	QA Executive	Head QA
Department	Packaging	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Label Reconciliation Sheet

Batch No.	Issued Labels	Used Labels	Rejected Labels	Returned Labels	Reconciled	Remarks
BN2025C10	5000	4980	10	10	Yes	OK

Annexure-2: Batch Coding Verification Log

Date	Batch No.	Printed Data Verified	Verified By	Remarks
24/06/2025	BN2025C10	Batch No., Mfg. Date, Exp. Date	Rajesh Kumar	Legible

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	Head QA
24/06/2025	2.0	Updated for automated labelers and digital coding	Annual Review	Head QA