manufacturing. This ensures accuracy, traceability, prevention of mix-ups, and regulatory compliance during production processes.

2. Scope

This SOP is applicable to all materials dispensed in the Gel Manufacturing Department intended for use in batch manufacturing of topical gel formulations. It covers primary and secondary labeling, cross-verification procedures, error correction, and documentation requirements.

3. Responsibilities

• Dispensing Operator: Responsible for printing and applying correct labels to the dispensed material containers.
• Supervisor: Verifies label content, ensures matching with the dispensing log and BMR.
• Quality Assurance (QA): Performs final cross-verification, signs release documentation, and maintains audit readiness of labeling records.

4. Accountability

The Head of Manufacturing is accountable for ensuring implementation of the labeling and cross-verification system and its compliance with current GMP standards.

5. Procedure

5.1 Label Generation and Printing

1. Upon completion of dispensing, the Dispensing Operator generates labels using the approved ERP or manual labeling format.
2. Each label must contain the following mandatory information:
   • Material Name and Code
   • Batch Number of Material
   • Dispensed Quantity
   • Weighed Date
   • Signature/Initials of Operator
   • Usage: Internal for Batch No. ______
3. Labels must be printed using indelible ink or thermal printers to prevent smudging or fading.

5.2 Label Application

1. Affix the printed label firmly on the dispensing container in a way that it is clearly visible and not easily removed.
2. Do not place labels on container caps or lids.
3. Ensure labels are applied on a clean, dry surface to avoid detachment during transport or handling.

5.3 First-Level Verification by Supervisor

1. The Production Supervisor shall:
   • Check the label content against the dispensing log and Batch Manufacturing Record.
   • Verify the weight dispensed matches the requisition.
   • Ensure the material name and batch numbers are correct.
2. Once verified, the supervisor must sign the Label Verification Form (Annexure-1).

5.4 Second-Level Verification by QA

1. QA Officer reviews the label, logbook entries, and reconciliation sheet.
2. Performs visual verification of label legibility, correctness, and adhesive strength.
3. Signs the Cross-Verification Record (Annexure-2) after successful verification.
4. Releases labeled materials for manufacturing use by stamping “Approved” on the container label.

5.5 Handling Labeling Errors

1. If an error is found in the label:
   • Do not overwrite or apply a second label on top.
   • Remove the incorrect label and paste a new one after correcting the data.
2. Document the error, reason, corrective action, and responsible personnel in the Label Error Log (Annexure-3).

5.6 Documentation

1. All labeling activities shall be recorded in the Label Tracking Sheet attached to the BMR.
2. Attach copies of each label to the batch documentation for archival.
3. Maintain records of cross-verification and approvals for a minimum of 5 years or as per site-specific retention policy.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• ERP: Enterprise Resource Planning

7. Documents

1. Label Verification Form – Annexure-1
2. Cross-Verification Record – Annexure-2
3. Label Error Log – Annexure-3

8. References

• WHO TRS 986 Annex 2: GMP for Pharmaceutical Products
• ICH Q10: Pharmaceutical Quality System
• Schedule M: Good Manufacturing Practices (India)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Label Verification Form

Material	Batch No.	Label Verified	Verified By	Date
Carbomer 940	CB94025	Yes	Supervisor	02/06/2025

Annexure-2: Cross-Verification Record

Material	Label Info Match	Container Checked	QA Verified By	Remarks
Carbomer 940	Yes	Yes	QA Officer	Approved

Annexure-3: Label Error Log

Date	Material	Error Noted	Action Taken	Recorded By
02/06/2025	Glycerin	Wrong Batch No.	Label Replaced	Sunita Reddy

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
02/06/2025	2.0	Included cross-verification procedures and updated annexures	Annual Review	QA Head