Standard Operating Procedure for Proper Labeling and Documentation of Relocated Raw Materials

Department	Warehouse / Quality Assurance / Inventory Control
SOP No.	SOP/RM/192/2025
Supersedes	SOP/RM/192/2022
Page No.	Page 1 of 15
Issue Date	27/04/2025
Effective Date	04/05/2025
Review Date	27/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the steps for proper labeling and documentation when relocating raw materials within the warehouse to ensure traceability, inventory accuracy, and GMP compliance.

2. Scope

This SOP applies to all warehouse staff involved in the relocation, labeling, and documentation of raw materials from one storage area to another within the facility.

3. Responsibilities

• Warehouse Personnel: Ensure accurate labeling and documentation during relocation activities.
• Inventory Control Team: Update inventory systems and verify the correctness of relocation data.
• Quality Assurance (QA) Team: Conduct audits to ensure compliance with labeling and documentation protocols.

4. Accountability

The Warehouse Manager is accountable for ensuring all raw material relocations are properly labeled and documented. The Inventory Control Manager is responsible for maintaining up-to-date inventory records, and the QA Manager ensures compliance through regular audits.

5. Procedure

5.1 Planning for Raw Material Relocation

1. Relocation Authorization:
   • Obtain written authorization from the Warehouse Manager before relocating any raw materials.
   • Record authorization details in the Relocation Authorization Log (Annexure-1).
2. Pre-Relocation Checklist:
   • Ensure that the new storage area meets environmental and safety requirements.
   • Document pre-relocation checks in the Pre-Relocation Checklist Log (Annexure-2).

5.2 Labeling of Relocated Raw Materials

1. Label Generation:
   • Generate new labels indicating the new storage location, date of relocation, and responsible personnel.
   • Record labeling details in the Labeling Log (Annexure-3).
2. Label Application:
   • Apply new labels securely to raw material containers, ensuring old labels are not removed but clearly marked as superseded.
   • Document label application in the Label Application Log (Annexure-4).

5.3 Documentation of Raw Material Relocation

1. Inventory System Update:
   • Update the inventory management system (ERP) with the new location and details of the raw material.
   • Document updates in the Inventory Update Log (Annexure-5).
2. Physical Relocation Documentation:
   • Record the physical movement of raw materials in the Relocation Movement Log (Annexure-6).

5.4 Handling Discrepancies and Non-Conformances

1. Identification of Discrepancies:
   • Report any discrepancies, such as mismatched batch numbers or incorrect labeling, immediately to the QA department.
   • Document discrepancies in the Non-Conformance Log (Annexure-7).
2. Corrective Actions:
   • Implement corrective actions to resolve discrepancies and prevent recurrence.
   • Record corrective actions in the Corrective Action Log (Annexure-8).

5.5 Training and Compliance Monitoring

1. Training:
   • Provide training to warehouse staff on proper relocation, labeling, and documentation procedures.
   • Record training sessions in the Training Log (Annexure-9).
2. Compliance Audits:
   • Conduct regular audits to ensure adherence to this SOP and identify areas for improvement.
   • Document audit results in the Compliance Audit Log (Annexure-9).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• ERP: Enterprise Resource Planning

7. Documents

1. Relocation Authorization Log (Annexure-1)
2. Pre-Relocation Checklist Log (Annexure-2)
3. Labeling Log (Annexure-3)
4. Label Application Log (Annexure-4)
5. Inventory Update Log (Annexure-5)
6. Relocation Movement Log (Annexure-6)
7. Non-Conformance Log (Annexure-7)
8. Corrective Action Log (Annexure-8)
9. Training Log (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Good Storage Practices for Pharmaceuticals
• FDA Guidance for Industry: Computerized Systems Used in Warehouse Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Relocation Authorization Log

Date	Material Name	Authorized By	Relocation Reason
27/04/2025	Acetaminophen API	Warehouse Manager	Space Optimization

Annexure-2: Pre-Relocation Checklist Log

Date	Material Name	Storage Conditions Verified	Checked By
27/04/2025	Acetaminophen API	Yes	Ravi Kumar

Annexure-3: Labeling Log

Date	Material Name	New Label Generated	Labeled By
27/04/2025	Acetaminophen API	Relocation Label – Zone B	Neha Verma

Annexure-4: Label Application Log

Date	Material Name	Old Label Status	New Label Applied By
27/04/2025	Acetaminophen API	Superseded	Amit Joshi

Annexure-5: Inventory Update Log

Date	Material Name	New Location Updated	Updated By
27/04/2025	Acetaminophen API	Zone B, Shelf 3	Kiran Patel

Annexure-6: Relocation Movement Log

Date	Material Name	From	To	Moved By
27/04/2025	Acetaminophen API	Zone A	Zone B	Amit Joshi

Annexure-7: Non-Conformance Log

Date	Material Name	Non-Conformance Details	Reported By
27/04/2025	Acetaminophen API	Labeling Error – Incorrect Batch Number	Ravi Kumar

Annexure-8: Corrective Action Log

Date	Non-Conformance	Corrective Action Taken	Performed By
27/04/2025	Labeling Error	Reprinted Correct Label	QA Team

Annexure-9: Training Log

Date	Employee Name	Training Topic	Trainer	Remarks
27/04/2025	Ravi Kumar	Labeling and Documentation Procedures	QA Manager	Completed Successfully

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
27/04/2025	2.0	Updated to include non-conformance and corrective action processes.	Regulatory Update	QA Head