SOP Guide for Pharma

SOP for Secure Storage of Flammable and Explosive Raw Materials – V 2.0

SOP for Secure Storage of Flammable and Explosive Raw Materials – V 2.0

Standard Operating Procedure for Secure Storage of Flammable and Explosive Raw Materials

Department Warehouse / Safety / Quality Assurance
SOP No. SOP/RM/175/2025
Supersedes SOP/RM/175/2022
Page No. Page 1 of 15
Issue Date 10/04/2025
Effective Date 17/04/2025
Review Date 10/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the guidelines for the secure storage of flammable and explosive raw materials to ensure safety, prevent accidents, and maintain compliance with Good Manufacturing Practices (GMP) and safety regulations.

2. Scope

This SOP applies to all warehouse, safety, and quality assurance (QA) personnel involved in the handling, storage, and monitoring of flammable and explosive raw materials within the facility.

3. Responsibilities

  • Warehouse Personnel: Ensure proper storage and handling of flammable and explosive materials.
  • Safety Officer: Conduct safety checks and ensure compliance with fire and explosion prevention protocols.
  • Quality Assurance (QA) Team: Verify storage conditions and document compliance.

4. Accountability

The Safety Manager is accountable for ensuring compliance with safety protocols, while the Warehouse Manager is responsible for proper storage. The QA Manager is responsible for periodic audits and documentation.

5. Procedure

5.1 Preparation and Storage Requirements

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  1. Material Identification:
    • Identify flammable and explosive materials based on Safety Data Sheets (SDS).
    • Ensure materials are labeled correctly, and details are logged in the Flammable Material Identification Log (Annexure-1).
  2. Storage Area Setup:
    • Store materials in explosion-proof, ventilated storage cabinets located in designated flammable storage areas.
    • Document storage conditions in the Flammable Material Storage Condition Log (Annexure-2).
  3. 5.2 Storage Conditions and Monitoring

    1. Temperature and Humidity Control:
      • Maintain storage temperature as per SDS guidelines (typically between 15°C and 25°C) and humidity below 60%.
      • Log readings in the Temperature and Humidity Monitoring Log (Annexure-3).
    2. Fire Safety Measures:
      • Install fire suppression systems and ensure fire extinguishers are accessible and inspected regularly.
      • Record fire safety equipment status in the Fire Safety Equipment Inspection Log (Annexure-4).

    5.3 Handling and Movement of Flammable Materials

    1. Material Handling Procedures:
      • Handle materials using spark-proof tools and anti-static clothing.
      • Document movements in the Flammable Material Movement Log (Annexure-5).
    2. Emergency Handling Protocols:
      • Follow emergency protocols in case of spills or fire, and document incidents in the Emergency Incident Log (Annexure-6).

    5.4 Training and Compliance

    1. Employee Training:
      • Provide regular training on flammable material handling and emergency procedures.
      • Document training sessions in the Flammable Material Handling Training Log (Annexure-7).
    2. Inspection and Audit:
      • Conduct monthly inspections and annual audits to ensure compliance with storage protocols.
      • Document findings in the Storage Inspection and Audit Log (Annexure-8).

    5.5 Non-Conformance and Corrective Actions

    1. Identifying Non-Conformance:
      • Log any non-conformances in the Flammable Material Non-Conformance Log (Annexure-9).
    2. Corrective Actions:
      • Implement corrective actions and document them in the non-conformance log, ensuring follow-up for resolution.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • GMP: Good Manufacturing Practice
    • QA: Quality Assurance
    • SDS: Safety Data Sheet

    7. Documents

    1. Flammable Material Identification Log (Annexure-1)
    2. Flammable Material Storage Condition Log (Annexure-2)
    3. Temperature and Humidity Monitoring Log (Annexure-3)
    4. Fire Safety Equipment Inspection Log (Annexure-4)
    5. Flammable Material Movement Log (Annexure-5)
    6. Emergency Incident Log (Annexure-6)
    7. Flammable Material Handling Training Log (Annexure-7)
    8. Storage Inspection and Audit Log (Annexure-8)
    9. Flammable Material Non-Conformance Log (Annexure-9)

    8. References

    • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
    • OSHA Standards for Hazardous Materials
    • WHO Guidelines on Good Storage Practices
    • NFPA (National Fire Protection Association) Guidelines

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    Annexure-1: Flammable Material Identification Log

    Date Material Name Batch Number Hazard Classification Identified By
    10/04/2025 Solvent A Batch 00123 Flammable Ravi Kumar

    Annexure-2: Flammable Material Storage Condition Log

    Date Material Name Storage Temperature (°C) Humidity (%) Inspected By
    10/04/2025 Solvent A 20°C 55% Neha Verma

    Annexure-3: Temperature and Humidity Monitoring Log

    Date Area Temperature (°C) Humidity (%) Checked By
    10/04/2025 Flammable Storage Room 18°C 50% Amit Joshi

    Annexure-4: Fire Safety Equipment Inspection Log

    Date Equipment Type Inspection Status Inspected By Remarks
    10/04/2025 Fire Extinguisher Functional Priya Singh No Issues

    Annexure-5: Flammable Material Movement Log

    Date Material Name Batch Number Moved From Moved To Moved By
    10/04/2025 Solvent A Batch 00123 Flammable Storage Room Processing Area Kiran Patel

    Annexure-6: Emergency Incident Log

    Date Incident Description Response Taken Handled By Remarks
    10/04/2025 Minor Spill Contained and Cleaned Ajay Sharma No Injury

    Annexure-7: Flammable Material Handling Training Log

    Date Employee Name Training Topic Trainer Remarks
    10/04/2025 Sanjay Mehta Flammable Material Handling QA Manager Successfully Completed

    Annexure-8: Storage Inspection and Audit Log

    Date Inspector Name Findings Corrective Actions
    10/04/2025 QA Supervisor Temperature Slightly High Adjusted Cooling System

    Annexure-9: Flammable Material Non-Conformance Log

    Date Non-Conformance Description Corrective Action Handled By Status
    10/04/2025 Improper Labeling Relabeled Correctly Neha Verma Closed

    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
    10/04/2025 2.0 Updated storage monitoring procedures and added emergency response protocols. Regulatory Update QA Head