Standard Operating Procedure for Labeling of Raw Materials During Dispensing

Department	Elixir Department
SOP No.	SOP/ELX/006/2025
Supersedes	SOP/ELX/006/2022
Page No.	Page 1 of 8
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To define the procedure for proper and compliant labeling of raw materials at the time of dispensing for elixir manufacturing. This ensures traceability, prevents mix-ups, and supports GMP documentation practices.

2. Scope

This SOP applies to all raw materials, including active pharmaceutical ingredients (APIs), excipients, and solvents, that are dispensed for the manufacturing of elixirs in the Elixir Department.

3. Responsibilities

• Dispensing Operator:
  • Ensure all containers are labeled immediately after dispensing.
• Production Supervisor:
  • Verify correctness of label content and completeness.
• QA Personnel:
  • Review and approve dispensed material labels before use in production.

4. Accountability

The Head of Quality Assurance and Head of Warehouse are accountable for ensuring that all dispensed materials are labeled as per regulatory and internal GMP requirements.

5. Procedure

5.1 Label Format

1. Use standardized label format as per Annexure-1.
2. Labels must include the following information:
   • Material Name
   • Material Code
   • Batch Number of the Raw Material
   • Quantity Dispensed
   • Dispensed On (Date)
   • Dispensed By (Operator’s Name)
   • Checked By (Verifier’s Name)
   • Product Name & Batch Number for which the material is dispensed
   • Storage Condition (if applicable)

5.2 Label Types

1. Use different colored labels for different material types to minimize errors:
   • Yellow – APIs
   • Green – Excipients
   • Red – Solvents
2. Labels must be non-removable, waterproof, and legible.

5.3 Labeling Process

1. Prepare labels using designated labeling software or pre-approved templates.
2. After dispensing the material, affix the label to the dispensing container before transferring it to production.
3. Labels should be affixed directly on the container body, not on the lid.
4. In case of multiple containers for a single material, each container should be labeled individually.

5.4 Verification

1. The Production Supervisor shall verify:
   • Label content vs. batch records
   • Legibility and correctness of each label
2. QA shall cross-check a sample of labels daily to ensure GMP compliance.

5.5 Error Handling

1. If an error is identified:
   • Do not overwrite the label.
   • Affix a new correct label after striking off the incorrect one with a single line.
   • Sign and date the correction.
   • Document the incident in the Label Correction Log (Annexure-2).

5.6 Label Storage and Control

1. Blank labels must be stored in a secure, controlled area.
2. Maintain a log of label issuance and consumption.
3. Scrap unused or rejected labels with QA oversight.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• API: Active Pharmaceutical Ingredient

7. Documents

1. Dispensing Label Format (Annexure-1)
2. Label Correction Log (Annexure-2)
3. Label Issuance Logbook

8. References

• 21 CFR Part 211 – Labeling Requirements
• WHO GMP Guidelines – Materials Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Dispensing Label Format

Material Name	Code	Batch No.	Dispensed Qty	Date	Dispensed By	Checked By	Product Name & Batch No.
Sucrose	RM-SUC-001	SC0425B	15.0 kg	13/04/2025	Rajesh Kumar	Sunita Reddy	Elixir A / EA-0425-002

Annexure-2: Label Correction Log

Date	Label No.	Material	Error Description	Corrected By	Remarks
13/04/2025	LBL-00157	Sucrose	Incorrect Batch No.	Sunita Reddy	New label affixed after correction

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/01/2022	1.0	Initial Version	New SOP	QA Head
13/04/2025	2.0	Added label issuance controls and correction log	Enhanced traceability	QA Head