SOP Guide for Pharma

SOP for Storage of Hazardous Chemicals in Compliance with Safety Regulations – V 2.0

Auditor

SOP for Storage of Hazardous Chemicals in Compliance with Safety Regulations – V 2.0

Standard Operating Procedure for Storage of Hazardous Chemicals in Compliance with Safety Regulations

Department Warehouse / Quality Assurance
SOP No. SOP/RM/116/2025
Supersedes SOP/RM/116/2022
Page No. Page 1 of 15
Issue Date 16/02/2025
Effective Date 20/02/2025
Review Date 16/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the safe storage of hazardous chemicals in compliance with safety regulations to prevent accidents, contamination, and ensure workplace safety.

2. Scope

This SOP applies to the storage of all hazardous chemicals, including flammable, corrosive, toxic, and reactive substances, within the warehouse and laboratory environments.

3. Responsibilities

4. Accountability

The Warehouse Manager is accountable for the proper storage of hazardous chemicals, while the QA Manager ensures compliance with regulatory and safety standards.

5. Procedure

5.1 Identification and Classification of Hazardous Chemicals

  1. Material Identification:
    • Identify hazardous chemicals using Material Safety Data Sheets (MSDS) and supplier documentation.
    • Label all chemicals clearly with hazard symbols and storage instructions.
    • Document identification details in the Hazardous Chemical Identification Log (Annexure-1).
  2. Classification of Chemicals:
    • Classify chemicals as flammable, corrosive, toxic, or reactive based on MSDS data.
    • Segregate incompatible chemicals to prevent dangerous reactions.
    • Document classifications in the Chemical Classification Log (Annexure-2).

See also  SOP for Emergency Procedures for Handling Chemical Spills at Receiving - V 2.0

5.2 Storage Requirements for Hazardous Chemicals

  1. Explosion-Proof Storage:
    • Store flammable chemicals in explosion-proof cabinets equipped with proper ventilation and grounding.
    • Ensure corrosive substances are stored in corrosion-resistant containers and cabinets.
    • Document storage details in the Hazardous Chemical Storage Log (Annexure-3).
  2. Labeling and Signage:
    • Clearly label storage areas with appropriate hazard signs and emergency contact information.
    • Ensure containers have intact and legible labels at all times.

5.3 Handling Procedures for Hazardous Chemicals

  1. Personal Protective Equipment (PPE):
    • Wear appropriate PPE, including gloves, goggles, face shields, and respirators when handling hazardous chemicals.
    • Document PPE issuance in the PPE Usage Log (Annexure-4).
  2. Safe Handling Practices:
    • Handle chemicals in designated areas with proper ventilation systems, such as fume hoods.
    • Ensure all containers are sealed properly after use to prevent leaks and vapors.
    • Document handling activities in the Chemical Handling Log (Annexure-5).

5.4 Monitoring and Maintenance of Storage Areas

  1. Regular Inspections:
    • Inspect storage areas weekly for signs of leaks, corrosion, or improper labeling.
    • Ensure emergency equipment (e.g., eyewash stations, fire extinguishers) is functional.
    • Document inspection results in the Storage Area Inspection Log (Annexure-6).
  2. Maintenance Procedures:
    • Repair any damaged containers or storage cabinets immediately to prevent exposure risks.
    • Document maintenance activities in the Maintenance Log (Annexure-7).

5.5 Handling of Deviations and Spills

  1. Deviation Detection:
    • Identify deviations such as leaks, temperature fluctuations, or improper storage conditions through regular monitoring.
    • Isolate affected chemicals immediately and report deviations to QA.
    • Document deviations in the Deviation Log (Annexure-8).
  2. Spill Response Procedures:
    • In case of a spill, evacuate the area and use appropriate spill kits and protective equipment.
    • Ventilate the area and safely dispose of contaminated materials following hazardous waste protocols.
    • Document spill responses in the Spill Response Log (Annexure-9).
See also  SOP for Coordination Between QA and Warehouse Teams for Quarantine Management - V 2.0

5.6 Periodic Review and Compliance Monitoring

  1. Warehouse Inspections:
    • Conduct routine inspections of hazardous chemical storage areas to ensure compliance with safety protocols.
    • Document inspection results in the Warehouse Inspection Log (Annexure-10).
  2. QA Compliance Audits:
    • QA will conduct quarterly audits to ensure hazardous chemical storage complies with regulatory requirements.
    • Document audit findings in the Compliance Audit Log (Annexure-11).

6. Abbreviations

7. Documents

  1. Hazardous Chemical Identification Log (Annexure-1)
  2. Chemical Classification Log (Annexure-2)
  3. Hazardous Chemical Storage Log (Annexure-3)
  4. PPE Usage Log (Annexure-4)
  5. Chemical Handling Log (Annexure-5)
  6. Storage Area Inspection Log (Annexure-6)
  7. Maintenance 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: Hazardous Chemical Identification Log

Date Chemical Name Hazard Classification Identified By
16/02/2025 Acetone Flammable Ravi Kumar

Annexure-2: Chemical Classification Log

Date Chemical Name Classification Documented By
16/02/2025 Sulfuric Acid Corrosive Sunita Sharma
See also  SOP for Cross-Verification of Vendor Details in Material Receipt Logs - V 2.0

Annexure-3: Hazardous Chemical Storage Log

Date Chemical Name Storage Area Stored By
16/02/2025 Acetone Explosion-Proof Cabinet 1 Ravi Kumar

Annexure-4: PPE Usage Log

Date Chemical Handled PPE Used Issued By
16/02/2025 Acetone Gloves, Goggles, Face Shield Anjali Mehta

Annexure-5: Chemical Handling Log

Date Chemical Name Handling Activity Handled By
16/02/2025 Acetone Transferred to QC Lab Sunita Sharma

Annexure-6: Storage Area Inspection Log

Date Area Inspected Findings Inspected By
16/02/2025 Hazardous Chemical Storage Room No issues detected Anjali Mehta

Annexure-7: Maintenance Log

Date Area Maintained Maintenance Activity Performed By
15/02/2025 Explosion-Proof Cabinet 1 Replaced ventilation filter Ravi Kumar

Annexure-8: Deviation Log

Date Deviation Action Taken Reported By
15/02/2025 Corrosive label missing on sulfuric acid container Reapplied label Sunita Sharma

Annexure-9: Spill Response Log

Date Chemical Spilled Spill Size Action Taken Handled By
15/02/2025 Acetone 200 ml Used spill kit, ventilated area Ravi Kumar

Annexure-10: Warehouse Inspection Log

Date Area Inspected Findings Corrective Actions Inspected By
16/02/2025 Hazardous Storage Area No deviations found N/A Anjali Mehta

Annexure-11: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
17/02/2025 Hazardous Chemical 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
16/02/2025 2.0 Updated Storage Procedures for Regulatory Compliance Regulatory Requirements QA Head
Exit mobile version