SOP Guide for Pharma

SOP for Handling and Storage of Volatile Raw Materials – V 2.0

Auditor

SOP for Handling and Storage of Volatile Raw Materials – V 2.0

Standard Operating Procedure for Handling and Storage of Volatile Raw Materials

Department Warehouse / Quality Assurance
SOP No. SOP/RM/112/2025
Supersedes SOP/RM/112/2022
Page No. Page 1 of 15
Issue Date 12/02/2025
Effective Date 16/02/2025
Review Date 12/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the correct procedures for the handling and storage of volatile raw materials to prevent safety hazards, contamination, and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all volatile raw materials, including organic solvents, chemicals, and reagents, stored and handled within the warehouse and production areas.

3. Responsibilities

4. Accountability

The Warehouse Manager is accountable for the safe storage and handling of volatile materials, while the QA Manager is responsible for ensuring compliance with regulatory and safety standards.

5. Procedure

5.1 Identification and Classification of Volatile Materials

  1. Material Identification:
    • Identify volatile materials from supplier documentation such as the Material Safety Data Sheet (MSDS) and Certificate of Analysis (COA).
    • Label all volatile materials clearly with hazard symbols, handling precautions, and storage instructions.
    • Document identification details in the Volatile Material Identification Log (Annexure-1).

5.2 Storage Requirements for Volatile Materials

  1. Ventilated and Explosion-Proof Storage:
    • Store volatile materials in explosion-proof storage cabinets or dedicated, well-ventilated rooms with flameproof lighting and electrical fittings.
    • Segregate incompatible materials (e.g., acids and bases) to prevent chemical reactions.
    • Document storage details in the Volatile Material Storage Log (Annexure-2).
  2. Temperature Control:
    • Maintain storage temperatures as specified in the MSDS, usually between 15°C and 25°C, unless otherwise stated.
    • Document temperature readings in the Temperature Monitoring Log (Annexure-3).
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5.3 Handling of Volatile Materials

  1. Personal Protective Equipment (PPE):
    • Ensure the use of appropriate PPE, including gloves, safety goggles, flame-resistant clothing, and respirators if required.
    • Document PPE checks and issuance in the PPE Usage Log (Annexure-4).
  2. Safe Handling Practices:
    • Handle materials in designated areas with appropriate ventilation, such as fume hoods or extraction systems.
    • Ensure all containers are tightly sealed immediately after use to prevent vapor release.
    • Document material handling activities in the Material Handling Log (Annexure-5).

5.4 Monitoring and Documentation

  1. Environmental Monitoring:
    • Continuously monitor storage areas for volatile vapor concentrations using gas detectors or sensors.
    • Inspect ventilation systems regularly to ensure functionality.
    • Document monitoring results in the Environmental Monitoring Log (Annexure-6).
  2. Calibration of Monitoring Devices:
    • Calibrate gas detectors and environmental monitoring devices at regular intervals per manufacturer guidelines.
    • Document calibration activities in the Calibration Log (Annexure-7).

5.5 Handling of Deviations and Spills

  1. Deviation Detection:
    • Identify deviations in vapor levels, temperature, or storage conditions through continuous monitoring.
    • Immediately isolate affected areas, evacuate personnel if needed, and initiate corrective actions.
    • Document deviations in the Deviation Log (Annexure-8).
  2. Spill Response Procedure:
    • In the event of a spill, follow the emergency response protocol, including using spill kits and notifying the safety team.
    • Ventilate the area immediately and dispose of contaminated materials according to hazardous waste protocols.
    • Document spill responses in the Spill Response Log (Annexure-9).
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5.6 Periodic Review and Compliance Monitoring

  1. Warehouse Inspections:
    • Conduct routine inspections to ensure compliance with safety protocols and proper storage of volatile materials.
    • Document inspection results in the Warehouse Inspection Log (Annexure-10).
  2. QA Compliance Audits:
    • QA will perform audits to ensure all handling and storage protocols for volatile materials comply with regulatory requirements.
    • Document audit findings in the Compliance Audit Log (Annexure-11).

6. Abbreviations

7. Documents

  1. Volatile Material Identification Log (Annexure-1)
  2. Volatile Material Storage Log (Annexure-2)
  3. Temperature Monitoring Log (Annexure-3)
  4. PPE Usage Log (Annexure-4)
  5. Material Handling Log (Annexure-5)
  6. Environmental Monitoring Log (Annexure-6)
  7. Calibration Log (Annexure-7)
  8. Deviation Log (Annexure-8)
  9. Spill Response Log (Annexure-9)
  10. Warehouse Inspection Log (Annexure-10)
  11. Compliance Audit Log (Annexure-11)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Volatile Material Identification Log

Date Material Name Batch Number Hazard Classification Identified By
12/02/2025 Acetone AC-2025-001 Flammable Liquid Ravi Kumar

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Annexure-2: Volatile Material Storage Log

Date Material Name Batch Number Storage Area Stored By
12/02/2025 Acetone AC-2025-001 Explosion-Proof Cabinet 1 Sunita Sharma

Annexure-3: Temperature Monitoring Log

Date Storage Area Temperature (°C) Recorded By
12/02/2025 Explosion-Proof Cabinet 1 20°C Ravi Kumar

Annexure-4: PPE Usage Log

Date Material Handled PPE Used Issued By
12/02/2025 Acetone Gloves, Goggles, Respirator Anjali Mehta

Annexure-5: Material Handling Log

Date Material Name Batch Number Handling Activity Handled By
12/02/2025 Acetone AC-2025-001 Transferred to QC Lab Sunita Sharma

Annexure-6: Environmental Monitoring Log

Date Storage Area Vapor Concentration (ppm) Recorded By
12/02/2025 Explosion-Proof Cabinet 1 5 ppm Ravi Kumar

Annexure-7: Calibration Log

Date Device Calibration Status Calibrated By
11/02/2025 Gas Detector 001 Calibrated Sunita Sharma

Annexure-8: Deviation Log

Date Deviation Action Taken Reported By
11/02/2025 Vapor concentration exceeded threshold Increased ventilation and isolated material Ravi Kumar

Annexure-9: Spill Response Log

Date Material Spilled Spill Size Action Taken Handled By
11/02/2025 Acetone 500 ml Used spill kit, ventilated area Sunita Sharma

Annexure-10: Warehouse Inspection Log

Date Area Inspected Inspector Findings Corrective Actions
12/02/2025 Explosion-Proof Cabinet 1 Anjali Mehta No deviations found N/A

Annexure-11: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
13/02/2025 Volatile Material Storage Compliance Audit Compliant N/A Anjali Mehta

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
12/02/2025 2.0 Updated Handling and Storage Procedures Regulatory Compliance QA Head
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