SOP Guide for Pharma

SOP for Warehouse Organization Based on Material Classification – V 2.0

Auditor

SOP for Warehouse Organization Based on Material Classification – V 2.0

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

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.

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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).
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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

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

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
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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
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