used in the production process.

4. Accountability

The Production Manager is accountable for ensuring that this SOP is followed during the labeling of dispensed materials and that any deviations are addressed. The overall compliance to this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Labeling of Dispensed Materials

1. Upon dispensing, the material should be transferred to a designated labeling area. Ensure that the material is in the correct container and ready for labeling.
2. Label the container with the required information, including but not limited to:
   • Material Name
   • Batch Number
   • Quantity Dispensed
   • Expiry Date
   • Production Date
   • Operator Name or Initials
3. Ensure that all information is legible, correct, and free from errors. Labels must be clear and tamper-evident where required.
4. If the material is subject to any specific storage requirements (e.g., temperature-controlled storage), include this information on the label as well.

5.2. Verification of Labels

1. The QC team will verify the labeling of all dispensed materials to ensure that the labels are correctly applied and that all required information is included.
2. Any discrepancies identified during verification (e.g., missing information, incorrect batch numbers, or expiry dates) must be documented, and the labels should be corrected immediately.
3. Once verified, the materials should be stored according to the specified storage requirements.

5.3. Handling Labeling Errors

1. If a labeling error is discovered, the incorrect labels must be removed and replaced with new, correct labels. A labeling error report must be completed to document the issue, including the cause of the error and the corrective actions taken.
2. Materials with labeling errors should not be used in production until the issue has been resolved and verified by the QC team.

5.4. Corrective and Preventive Actions (CAPA)

1. In the event of repeated labeling errors, a root cause analysis should be conducted to determine the underlying cause(s) of the problem.
2. Corrective actions should be taken to address the immediate issue, such as retraining personnel, adjusting procedures, or updating equipment.
3. Preventive actions should be implemented to ensure that future labeling errors are minimized, including process improvements, enhanced verification procedures, or more detailed labeling instructions.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions

7. Documents

1. Labeling Log (Annexure-1)
2. Labeling Discrepancy Report (Annexure-2)
3. Labeling Verification Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Labeling Log

Material Name	Batch No.	Labeling Date	Operator	Label Information
Example Material	12345	06/02/2025	Ravi Kumar	Batch No., Expiry Date, Quantity Dispensed

Annexure-2: Labeling Discrepancy Report

Discrepancy Description	Action Taken	Responsible Party	Resolution Date
Missing Expiry Date	New label applied	Ravi Kumar	07/02/2025

Annexure-3: Labeling Verification Log

Material Name	Batch No.	Verification Date	Verified By	Verification Result
Example Material	12345	06/02/2025	Rajesh Patel	Verified

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated labeling procedures and added corrective actions	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures