Standard Operating Procedure for Proper Shelving and Racking of Raw Materials
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/120/2025 |
| Supersedes | SOP/RM/120/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 20/02/2025 |
| Effective Date | 24/02/2025 |
| Review Date | 20/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the correct procedures for shelving and racking raw materials in the warehouse to prevent contamination, ensure safety, and maintain compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all shelving and racking activities in the warehouse, including the storage of Active Pharmaceutical Ingredients (APIs), excipients, and other raw materials.
3. Responsibilities
- Warehouse Personnel: Follow shelving and racking procedures, ensure materials are correctly placed, and report any irregularities.
- Warehouse Manager: Oversee shelving and racking operations, ensure compliance with SOP, and conduct routine inspections.
- Quality Assurance (QA): Verify the correct implementation of shelving procedures and conduct periodic audits.
4. Accountability
The Warehouse Manager is accountable for proper shelving and racking operations, while the QA Manager ensures compliance with GMP and regulatory standards.
5. Procedure
5.1 Shelving and Racking Requirements
- Material Segregation:
- Store raw materials according to their type (APIs, excipients, solvents) and physical properties.
- Segregate materials based on status: Approved, Quarantined, and Rejected, using color-coded labels.
- Document material placement in the Shelving Log (Annexure-1).
- Racking Specifications:
- Use metal shelving units with rust-resistant coatings and smooth surfaces to prevent contamination.
- Ensure shelves are at least 6 inches off the floor and 18 inches from walls to facilitate cleaning and prevent pest infestation.
- Document racking specifications in the Racking Configuration Log (Annexure-2).
5.2 Shelving and Racking Procedures
- Material Placement:
- Place heavier materials on lower shelves to prevent accidents and ensure stability.
- Ensure labels on materials face outward for easy identification.
- Document material placement in the Material Placement Log (Annexure-3).
- FIFO and FEFO Implementation:
- Follow First-In, First-Out (FIFO) and First-Expiry, First-Out (FEFO) principles to ensure proper material rotation.
- Ensure older or near-expiry materials are easily accessible.
- Document rotation activities in the FIFO/FEFO Log (Annexure-4).
5.3 Safety and Compliance
- Load Capacity Management:
- Do not exceed the load capacity specified by the racking manufacturer.
- Ensure even weight distribution across shelves to prevent tipping or collapse.
- Document load checks in the Load Capacity Log (Annexure-5).
- Fire Safety and Accessibility:
- Maintain clear access to fire exits, fire extinguishers, and emergency equipment.
- Ensure materials are stored at least 18 inches below sprinkler systems to allow proper operation during emergencies.
- Document fire safety inspections in the Fire Safety Inspection Log (Annexure-6).
5.4 Inspection and Maintenance
- Routine Inspections:
- Inspect shelving and racking systems weekly for structural integrity, signs of corrosion, and pest activity.
- Report any damages or issues to the Warehouse Manager immediately.
- Document inspections in the Shelving and Racking Inspection Log (Annexure-7).
- Maintenance Procedures:
- Perform maintenance activities, such as tightening loose bolts or replacing damaged shelves, as needed.
- Document maintenance activities in the Maintenance Log (Annexure-8).
5.5 Handling of Deviations
- Deviation Reporting:
- Identify deviations, such as incorrect material placement, damaged shelving, or overloading.
- Report deviations to QA and Warehouse Manager immediately.
- Document deviations in the Deviation Log (Annexure-9).
- Corrective Actions:
- Implement corrective actions such as rearranging materials, replacing damaged racks, or retraining staff.
- Document corrective actions in the Corrective Action Log (Annexure-10).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- FIFO: First-In, First-Out
- FEFO: First-Expiry, First-Out
7. Documents
- Shelving Log (Annexure-1)
- Racking Configuration Log (Annexure-2)
- Material Placement Log (Annexure-3)
- FIFO/FEFO Log (Annexure-4)
- Load Capacity Log (Annexure-5)
- Fire Safety Inspection Log (Annexure-6)
- Shelving and Racking Inspection Log (Annexure-7)
- Maintenance Log (Annexure-8)
- Deviation Log (Annexure-9)
- Corrective Action Log (Annexure-10)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- OSHA Warehouse Safety Standards
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Shelving Log
| Date | Material Name | Storage Area | Placed By |
|---|---|---|---|
| 20/02/2025 | API A | Shelf 1, Row A | Ravi Kumar |
Annexure-2: Racking Configuration Log
| Date | Rack ID | Configuration Details | Inspected By |
|---|---|---|---|
| 19/02/2025 | Rack-01 | Metal Shelves, 5 Tiers | Sunita Sharma |
Annexure-3: Material Placement Log
| Date | Material Name | Location | Placed By |
|---|---|---|---|
| 20/02/2025 | Excipients B | Shelf 2, Row B | Anjali Mehta |
Annexure-4: FIFO/FEFO Log
| Date | Material Name | Batch No. | Expiry Date | Action Taken | Performed By |
|---|---|---|---|---|---|
| 19/02/2025 | API C | Batch 123 | 01/01/2026 | Moved to Front for Use | Ravi Kumar |
Annexure-5: Load Capacity Log
| Date | Rack ID | Load Capacity | Current Load | Checked By |
|---|---|---|---|---|
| 18/02/2025 | Rack-01 | 500 kg | 450 kg | Sunita Sharma |
Annexure-6: Fire Safety Inspection Log
| Date | Area Inspected | Findings | Corrective Actions | Inspected By |
|---|---|---|---|---|
| 17/02/2025 | Shelf 3, Row C | No Obstruction Detected | N/A | Anjali Mehta |
Annexure-7: Shelving and Racking Inspection Log
| Date | Rack ID | Inspection Findings | Corrective Actions | Inspected By |
|---|---|---|---|---|
| 16/02/2025 | Rack-02 | Loose Bolts Found | Bolts Tightened | Ravi Kumar |
Annexure-8: Maintenance Log
| Date | Rack ID | Maintenance Performed | Performed By |
|---|---|---|---|
| 15/02/2025 | Rack-03 | Replaced Rusted Shelves | Anjali Mehta |
Annexure-9: Deviation Log
| Date | Deviation | Corrective Action | Reported By |
|---|---|---|---|
| 14/02/2025 | Incorrect Material Placement | Rearranged Correctly | Sunita Sharma |
Annexure-10: Corrective Action Log
| Date | Issue | Corrective Action | Performed By |
|---|---|---|---|
| 13/02/2025 | Overloaded Shelf | Removed Excess Load | Ravi Kumar |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 20/02/2025 | 2.0 | Updated Shelving and Racking Procedures | Regulatory Compliance | QA Head |