for ensuring compliance with regulatory standards and verifying the reorganization process.

5. Procedure

5.1 Planning the Reorganization

1. Assessment of Current Warehouse Layout:
   • Conduct a thorough assessment of the current warehouse layout, identifying areas of inefficiency or congestion.
   • Evaluate storage conditions such as temperature, humidity, and accessibility.
   • Document the assessment in the Warehouse Assessment Log (Annexure-1).
2. Development of Reorganization Plan:
   • Develop a reorganization plan that optimizes the use of space while ensuring easy access to frequently used materials.
   • Ensure segregation of materials based on their classification (e.g., hazardous, temperature-sensitive, etc.).
   • Document the plan in the Reorganization Plan Log (Annexure-2).

5.2 Implementation of Reorganization

1. Preparation for Reorganization:
   • Inform all warehouse personnel about the reorganization schedule and assign specific roles and responsibilities.
   • Ensure the availability of necessary equipment such as forklifts, trolleys, and labeling tools.
   • Document the preparation details in the Reorganization Preparation Log (Annexure-3).
2. Execution of Reorganization:
   • Begin by moving non-essential or excess materials to temporary holding areas.
   • Relocate materials according to the updated layout plan, ensuring proper labeling and segregation.
   • Ensure that materials are placed on pallets or shelves to prevent direct contact with the floor.
   • Document the execution process in the Reorganization Execution Log (Annexure-4).

5.3 Verification and Documentation

1. QA Verification:
   • QA personnel must verify that the reorganization complies with GMP guidelines and that all materials are properly labeled and stored.
   • Document QA verification in the QA Verification Log (Annexure-5).
2. Updating ERP and Inventory Systems:
   • Update the ERP or inventory management system to reflect new storage locations.
   • Ensure that all documentation related to the reorganization is archived for future reference.
   • Document ERP updates in the Inventory Update Log (Annexure-6).

5.4 Handling Deviations and Corrective Actions

1. Reporting Deviations:
   • Report any deviations, such as incorrect placement of materials or failure to follow the reorganization plan, to the Warehouse Manager and QA.
   • Document deviations in the Deviation Log (Annexure-7).
2. Corrective Actions:
   • Investigate the cause of deviations and implement corrective measures, such as retraining staff or adjusting the reorganization plan.
   • Document corrective actions in the Corrective Action Log (Annexure-8).

6. Abbreviations

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

7. Documents

1. Warehouse Assessment Log (Annexure-1)
2. Reorganization Plan Log (Annexure-2)
3. Reorganization Preparation Log (Annexure-3)
4. Reorganization Execution Log (Annexure-4)
5. QA Verification Log (Annexure-5)
6. Inventory Update Log (Annexure-6)
7. Deviation Log (Annexure-7)
8. Corrective Action Log (Annexure-8)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO GMP Guidelines
• ISO 9001:2015 – Quality Management Systems Requirements

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Warehouse Assessment Log

Date	Area Assessed	Findings	Assessed By
28/02/2025	Storage Area A	Congested, requires reorganization	Ravi Kumar

Annexure-2: Reorganization Plan Log

Date	Plan Description	Prepared By
28/02/2025	Reallocate high-use materials to front rows, segregate hazardous materials.	Sunita Sharma

Annexure-3: Reorganization Preparation Log

Date	Preparation Activity	Performed By
01/03/2025	Equipment inspection and team briefing	Amit Joshi

Annexure-4: Reorganization Execution Log

Date	Activity	Completed By
02/03/2025	Relocation of materials to new shelves	Neha Verma

Annexure-5: QA Verification Log

Date	Verification Description	Verified By
03/03/2025	Checked compliance with GMP storage guidelines	Priya Singh

Annexure-6: Inventory Update Log

Date	Material Name	New Location	Updated By
03/03/2025	API A	Shelf B-2	Anjali Mehta

Annexure-7: Deviation Log

Date	Deviation Description	Reported By	Corrective Action Taken
03/03/2025	Incorrect labeling of relocated materials	Sachin Gupta	Relabeling performed

Annexure-8: Corrective Action Log

Date	Corrective Action Description	Implemented By	Verified By
04/03/2025	Staff retraining on reorganization protocols	Rajeev Menon	QA Head – Priya Singh

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
28/02/2025	2.0	Updated Procedures for Warehouse Optimization	Regulatory Compliance	QA Head