Procedure for Material Labeling Post-Weighing

Department	Production/Quality Assurance (QA)/Quality Control (QC)/Warehouse
SOP No.	SOP/Ointment/175
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for labeling raw materials post-weighing to ensure accurate identification, traceability, and compliance with Good Manufacturing Practices (GMP) and regulatory guidelines.

2. Scope

This SOP applies to all personnel involved in the weighing, labeling, and handling of raw materials in the Production, Quality Assurance (QA), Quality Control (QC), and Warehouse departments in pharmaceutical manufacturing.

3. Responsibilities

• Weighing Operator: Accurately labels weighed materials according to batch specifications.
• QA Officer: Verifies labeling accuracy and ensures compliance with documentation standards.
• QC Analyst: Cross-checks labeled materials to ensure identity and quality compliance.
• Warehouse Supervisor: Ensures proper storage and segregation of labeled materials.
• Production Supervisor: Oversees the labeling process and ensures adherence to protocols.

4. Accountability

The QA Manager is accountable for ensuring that all material labeling activities comply with GMP, FDA, ICH, WHO, and company policies.

5. Procedure

5.1 Preparation for Labeling

• Ensure the **labeling area is clean** and meets environmental control conditions:
• Temperature: **15-25°C**
• Humidity: **30-50% RH**
• Verify that all raw materials have been **accurately weighed and documented**.
• Check the label template to ensure it includes the required details:
• Material Name
• Batch Number
• Weighed Quantity
• Weighing Date
• Operator Name
• QA Verification Status
• Ensure **barcode or unique identification number** is assigned to each label.

5.2 Labeling Process

• Prepare **pre-printed labels** or use **automated label printing systems**.
• Each label must be checked against the **Batch Manufacturing Record (BMR)** for accuracy.
• Affix the label securely on the container, ensuring it is:
  • Legible and clear.
  • Firmly attached.
  • Placed in a **non-obstructive** location.
• Record the labeled material details in the **Material Labeling Log (Annexure-1).**

5.3 Handling Labeling Deviations

• If a label is found incorrect:
  • Immediately stop further labeling.
  • Notify the QA department for corrective action.
  • Remove and replace the incorrect label.
• Document any incorrect labels in the **Labeling Deviation Log (Annexure-2).**

5.4 Post-Labeling Activities

• Store labeled materials in **designated areas based on their batch number and category**.
• Ensure that **segregation is maintained** between different batches.
• Submit completed **labeling records** to the QA department for verification.

5.5 Label Verification and Quality Checks

• QA must verify **all labels at the end of the labeling process**.
• Any discrepancies must be resolved before materials are transferred for manufacturing.
• QC must perform **random sampling checks** to ensure proper labeling adherence.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Material Labeling Log (Annexure-1)
• Labeling Deviation Log (Annexure-2)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• WHO Guidelines on Labeling and Packaging
• FDA Guidance on Pharmaceutical Labeling Compliance

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Labeling Log

Date	Material Name	Batch No.	Weighed Quantity	Label Status	Operator	QA Review
02/02/2025	API X	SOP/Ointment/1001	5.0 kg	Correct	John Doe	Approved

Annexure-2: Labeling Deviation Log

Date	Material Name	Batch No.	Deviation Type	Root Cause	Corrective Action	QA Approval
02/02/2025	API X	SOP/Ointment/1001	Wrong Batch Number	Operator Error	Reprinted Label	Approved

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Labeling Process	Improved Traceability	QA Head