accountable for ensuring efficient space utilization and adherence to storage protocols. The QA Manager is responsible for verifying that overcrowded conditions do not affect the quality or integrity of stored raw materials.

5. Procedure

5.1 Assessment of Warehouse Space

1. Initial Space Assessment:
   • Conduct a weekly evaluation of available storage space to identify potential overcrowding issues.
   • Document the space assessment in the Warehouse Space Assessment Log (Annexure-1).
2. Material Categorization:
   • Classify materials based on priority (e.g., frequently used, hazardous, temperature-sensitive) and adjust storage accordingly.
   • Segregate materials based on their properties to prevent cross-contamination.
   • Document material categorization in the Material Classification Log (Annexure-2).

5.2 Optimization of Storage Space

1. Reorganization Strategies:
   • Utilize vertical storage solutions (e.g., racks, shelves) to maximize space.
   • Implement First-In-First-Out (FIFO) and First-Expired-First-Out (FEFO) methods to reduce material buildup.
   • Relocate non-essential or slow-moving materials to off-site storage if necessary.
   • Document storage reorganization activities in the Storage Reorganization Log (Annexure-3).
2. Temporary Storage Solutions:
   • Use temporary storage containers or trailers if authorized by the Warehouse Manager and QA.
   • Ensure temporary storage conditions comply with GMP requirements.
   • Document temporary storage arrangements in the Temporary Storage Log (Annexure-4).

5.3 Inventory Management in Overcrowded Conditions

1. Inventory Tracking:
   • Update inventory records in real-time to reflect material movement and storage locations.
   • Use barcode scanners or RFID tags for precise tracking and easy retrieval of materials.
   • Document inventory updates in the Inventory Management Log (Annexure-5).
2. Stock Level Monitoring:
   • Coordinate with the procurement team to adjust order quantities based on current warehouse capacity.
   • Prioritize the dispatch of materials nearing expiration or with high turnover rates.
   • Document stock level adjustments in the Stock Adjustment Log (Annexure-6).

5.4 Safety Measures in Overcrowded Warehouses

1. Safety Protocols:
   • Ensure clear aisles and emergency exits are maintained, even during overcrowding.
   • Use appropriate signage to indicate hazardous material locations and ensure materials are not stacked beyond safe limits.
   • Document safety inspections in the Warehouse Safety Inspection Log (Annexure-7).
2. Emergency Preparedness:
   • Conduct regular emergency drills to prepare staff for potential hazards related to overcrowded conditions.
   • Ensure fire extinguishers and safety equipment are accessible and functional.
   • Document emergency preparedness activities in the Emergency Preparedness Log (Annexure-8).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• FIFO: First-In-First-Out
• FEFO: First-Expired-First-Out

7. Documents

1. Warehouse Space Assessment Log (Annexure-1)
2. Material Classification Log (Annexure-2)
3. Storage Reorganization Log (Annexure-3)
4. Temporary Storage Log (Annexure-4)
5. Inventory Management Log (Annexure-5)
6. Stock Adjustment Log (Annexure-6)
7. Warehouse Safety Inspection Log (Annexure-7)
8. Emergency Preparedness Log (Annexure-8)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• OSHA Warehouse Safety Guidelines (29 CFR 1910)
• WHO Guidelines for Pharmaceutical Storage and Distribution

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Warehouse Space Assessment Log

Date	Assessed By	Total Available Space (sq ft)	Utilized Space (sq ft)	Overcrowding Status (Yes/No)	Remarks
16/03/2025	Ravi Kumar	5000	4800	Yes	Initiate reorganization to free up space
16/03/2025	Neha Verma	3000	2500	No	Space sufficient for incoming stock

Annexure-2: Material Classification Log

Date	Material Name	Batch Number	Category (Hazardous/Non-Hazardous/Temperature-Sensitive)	Storage Priority (High/Medium/Low)	Classified By
16/03/2025	Sodium Hydroxide	NAOH-5678	Hazardous	High	Priya Singh
16/03/2025	Citric Acid	CA-1234	Non-Hazardous	Medium	Amit Joshi

Annexure-3: Storage Reorganization Log

Date	Action Taken	Materials Moved	Old Location	New Location	Handled By
16/03/2025	Shifted non-essential items to off-site storage	Calcium Carbonate (Batch CC-7890)	Warehouse A1	Off-site Storage B	Ravi Kumar
16/03/2025	Reorganized shelving for vertical stacking	Hydrochloric Acid (Batch HCL-4567)	Warehouse A3	Warehouse A5	Neha Verma

Annexure-4: Temporary Storage Log

Date	Material Name	Batch Number	Temporary Storage Location	Duration of Storage	Authorized By
16/03/2025	Potassium Nitrate	PN-6789	Storage Container C1	7 days	Priya Singh
16/03/2025	Sodium Bicarbonate	SB-2345	Temporary Storage Trailer D2	5 days	Amit Joshi

Annexure-5: Inventory Management Log

Date	Material Name	Batch Number	Quantity (kg/l)	Location	Updated By
16/03/2025	Hydrochloric Acid	HCL-4567	200 L	Warehouse A5	Ravi Kumar
16/03/2025	Citric Acid	CA-1234	150 kg	Warehouse B2	Neha Verma

Annexure-6: Stock Adjustment Log

Date	Material Name	Batch Number	Adjustment Type (Addition/Removal)	Adjusted Quantity	Reason for Adjustment	Adjusted By
16/03/2025	Sodium Hydroxide	NAOH-5678	Removal	50 kg	Dispatched to production	Priya Singh
16/03/2025	Potassium Nitrate	PN-6789	Addition	100 kg	New shipment received	Amit Joshi

Annexure-7: Warehouse Safety Inspection Log

Date	Inspected By	Inspection Area	Issues Found	Corrective Actions Taken	Status (Resolved/Pending)
16/03/2025	Neha Verma	Warehouse A1	Blocked emergency exit	Cleared path, installed additional signage	Resolved
16/03/2025	Ravi Kumar	Warehouse B2	Overstacked materials beyond safe limit	Reduced stack height, reinforced shelves	Resolved

Annexure-8: Emergency Preparedness Log

Date	Type of Drill	Participants	Issues Identified	Corrective Actions Taken	Verified By
16/03/2025	Fire Drill	All warehouse staff	Delayed response in evacuating overcrowded areas	Revised evacuation plan, added additional exits	Priya Singh
16/03/2025	Chemical Spill Drill	Warehouse A1 Team	Insufficient spill kits available	Procured additional spill kits, retrained staff	Amit Joshi

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
16/03/2025	2.0	Updated warehouse optimization procedures	To address increased material volume and safety concerns	QA Head