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

1. 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).
2. 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

1. 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).
2. 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

1. 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).
2. 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

1. 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).
2. 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

1. Shelving Log (Annexure-1)
2. Racking Configuration Log (Annexure-2)
3. Material Placement Log (Annexure-3)
4. FIFO/FEFO Log (Annexure-4)
5. Load Capacity Log (Annexure-5)
6. Fire Safety Inspection Log (Annexure-6)
7. Shelving and Racking Inspection Log (Annexure-7)
8. Maintenance Log (Annexure-8)
9. Deviation Log (Annexure-9)
10. 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