Standard Operating Procedure for Warehouse Organization Based on Material Classification

Department	Warehouse / Quality Assurance / Safety
SOP No.	SOP/RM/184/2025
Supersedes	SOP/RM/184/2022
Page No.	Page 1 of 15
Issue Date	19/04/2025
Effective Date	26/04/2025
Review Date	19/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the method for organizing raw materials in the warehouse based on material classification to enhance safety, ensure compliance with Good Manufacturing Practices (GMP), and improve operational efficiency.

2. Scope

This SOP applies to all personnel involved in the receipt, storage, and handling of raw materials, including APIs, excipients, solvents, hazardous materials, and temperature-sensitive materials in the warehouse.

3. Responsibilities

• Warehouse Personnel: Ensure materials are stored in designated areas based on their classification and update storage records accordingly.
• Quality Assurance (QA) Team: Verify that storage practices comply with GMP and conduct routine audits of warehouse organization.
• Safety Team: Ensure proper safety measures are implemented based on material classification, including segregation of hazardous materials.

4. Accountability

The Warehouse Manager is accountable for the correct classification and storage of materials, the QA Manager ensures compliance with regulatory requirements, and the Safety Officer oversees adherence to safety protocols.

5. Procedure

5.1 Material Classification

1. Material Categories:
   • Classify materials into categories such as APIs, excipients, solvents, flammable materials, temperature-sensitive materials, and hazardous chemicals.
   • Document material classification in the Material Classification Log (Annexure-1).
2. Labeling and Identification:
   • Use color-coded labels and clear signage to identify material categories and storage areas.
   • Record labeling details in the Material Labeling Log (Annexure-2).

5.2 Warehouse Zoning and Organization

1. Designating Storage Zones:
   • Allocate specific zones for each material category, ensuring compliance with regulatory guidelines for segregation.
   • Document zoning plans in the Warehouse Zoning Log (Annexure-3).
2. Storage Layout:
   • Ensure proper shelving, racking, and spacing to prevent cross-contamination and ensure material stability.
   • Record layout details in the Storage Layout Log (Annexure-4).

5.3 Safety and Compliance Measures

1. Hazardous Material Handling:
   • Store hazardous materials in dedicated, well-ventilated areas with appropriate safety signage.
   • Document safety measures in the Hazardous Material Safety Log (Annexure-5).
2. Temperature and Humidity Control:
   • Maintain specified environmental conditions for sensitive materials and regularly monitor storage parameters.
   • Record environmental control activities in the Environmental Monitoring Log (Annexure-6).

5.4 Documentation and Review

1. Regular Audits:
   • Conduct quarterly audits of warehouse organization and material classification compliance.
   • Document audit findings in the Warehouse Audit Log (Annexure-7).
2. Record Keeping:
   • Maintain comprehensive records of material classification, storage zones, and safety compliance.
   • Record updates in the Record Keeping Log (Annexure-8).

5.5 Training and Continuous Improvement

1. Personnel Training:
   • Conduct training sessions on warehouse organization principles and safety protocols based on material classification.
   • Document training sessions in the Training Log (Annexure-9).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Material Classification Log (Annexure-1)
2. Material Labeling Log (Annexure-2)
3. Warehouse Zoning Log (Annexure-3)
4. Storage Layout Log (Annexure-4)
5. Hazardous Material Safety Log (Annexure-5)
6. Environmental Monitoring Log (Annexure-6)
7. Warehouse Audit Log (Annexure-7)
8. Record Keeping Log (Annexure-8)
9. Training Log (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Good Storage Practices for Pharmaceuticals
• OSHA Guidelines on Warehouse Safety

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Material Classification Log

Date	Material Name	Classification	Classified By
19/04/2025	API X	Temperature-Sensitive	Ravi Kumar

Annexure-2: Material Labeling Log

Date	Material Name	Label Type	Labeled By
19/04/2025	API X	Red (Flammable)	Neha Verma

Annexure-3: Warehouse Zoning Log

Date	Zone Name	Material Category	Assigned By
19/04/2025	Zone A	APIs	Amit Joshi

Annexure-4: Storage Layout Log

Date	Storage Area	Layout Description	Configured By
19/04/2025	Zone A	Racking System with 1-meter spacing	Kiran Patel

Annexure-5: Hazardous Material Safety Log

Date	Material Name	Safety Measures Implemented	Verified By
19/04/2025	Solvent Y	Stored in explosion-proof cabinet	QA Supervisor

Annexure-6: Environmental Monitoring Log

Date	Zone	Temperature (°C)	Humidity (%)	Checked By
19/04/2025	Zone B	22°C	45%	Ajay Sharma

Annexure-7: Warehouse Audit Log

Date	Audit Area	Findings	Audited By
19/04/2025	Hazardous Materials	No issues found	QA Head

Annexure-8: Record Keeping Log

Date	Document Name	Status	Updated By
19/04/2025	Material Classification Log	Updated	Sanjay Mehta

Annexure-9: Training Log

Date	Employee Name	Training Topic	Trainer	Remarks
19/04/2025	Ravi Kumar	Material Classification and Storage	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
19/04/2025	2.0	Updated warehouse zoning and classification protocols.	Regulatory Update	QA Head