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
- Relocation Authorization:
- Obtain written authorization from the Warehouse Manager before relocating any raw materials.
- Record authorization details in the Relocation Authorization Log (Annexure-1).
- 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
- 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).
- 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- Apply new labels securely to raw material containers, ensuring old labels are not removed but clearly marked as superseded.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
- 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).
- Physical Relocation Documentation:
- Record the physical movement of raw materials in the Relocation Movement Log (Annexure-6).
5.4 Handling Discrepancies and Non-Conformances
- 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).
- 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
- Training:
- Provide training to warehouse staff on proper relocation, labeling, and documentation procedures.
- Record training sessions in the Training Log (Annexure-9).
- 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
- Relocation Authorization Log (Annexure-1)
- Pre-Relocation Checklist Log (Annexure-2)
- Labeling Log (Annexure-3)
- Label Application Log (Annexure-4)
- Inventory Update Log (Annexure-5)
- Relocation Movement Log (Annexure-6)
- Non-Conformance Log (Annexure-7)
- Corrective Action Log (Annexure-8)
- 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 |