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API Manufacturing: SOP for Fire Hazard Control Measures – V 2.0

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API Manufacturing: SOP for Fire Hazard Control Measures – V 2.0

Standard Operating Procedure for Fire Hazard Control Measures in API Manufacturing

Department API Manufacturing
SOP No. SOP/API/054/2025
Supersedes SOP/API/054/2022
Page No. Page 1 of 10
Issue Date 13/04/2025
Effective Date 15/04/2025
Review Date 13/04/2026

1. Purpose

To define fire hazard control measures in API manufacturing facilities to prevent, detect, and respond to potential fire incidents, ensuring safety of personnel, equipment, and compliance with statutory and GMP regulations.

2. Scope

This SOP applies to all manufacturing blocks, solvent handling areas, recovery units, warehouses, and utility sections of the API manufacturing plant.

3. Responsibilities

  • Production and
Maintenance Teams: Follow preventive measures and report any fire risks.
  • EHS Department: Conduct regular audits, fire drills, and maintain fire control equipment.
  • Security Team: Respond immediately in case of fire alarms and support evacuation.
  • QA Department: Review SOP implementation and audit compliance during inspections.
  • 4. Accountability

    The EHS Head is accountable for execution and monitoring of all fire safety measures. Department Heads are responsible for team training and adherence to fire safety protocols.

    5. Procedure

    5.1 Fire Prevention Measures

    1. Use flameproof electrical fittings in flammable zones.
    2. Ensure solvents are stored in bonded, grounded, and ventilated enclosures.
    3. Prohibit use of open flames, smoking, and mobile phones in solvent handling areas.
    4. Conduct regular preventive maintenance of machines, motors, and exhausts.
    5. Ensure LOTO (Lock-Out Tag-Out) before repair in flammable zones.

    5.2 Fire Detection Systems

    1. Install fire detectors, smoke sensors, and heat sensors across solvent storage, production floors, and utility areas.
    2. Check sensor calibration every 6 months and record in the “Fire System Maintenance Log” (Annexure-1).
    3. Connect all detectors to a centralized fire alarm panel and link with audible/visual alarms.

    5.3 Firefighting Equipment and Signage

    1. Install fire extinguishers (foam, dry chemical, CO₂) at designated points as per NFPA spacing.
    2. Ensure fire hydrants, hose reels, sand buckets, and emergency showers are clearly labeled and accessible.
    3. Update location maps and fire exits annually.

    5.4 Training and Drills

    1. Conduct fire mock drills every quarter in each building block.
    2. Maintain “Fire Drill Participation Record” (Annexure-2).
    3. Train staff on:
      • Emergency response
      • Evacuation protocols
      • Use of extinguishers and alarm systems

    5.5 Fire Emergency Protocol

    1. On detection of fire:
      • Activate nearest alarm
      • Evacuate as per assembly plan
      • Use extinguishers only if trained and safe to do so
      • Inform fire department and internal emergency response team
    2. Record incident in “Fire Incident Log” (Annexure-3) and conduct CAPA investigation.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • EHS: Environment, Health and Safety
    • LOTO: Lock-Out Tag-Out
    • NFPA: National Fire Protection Association
    • CAPA: Corrective and Preventive Action

    7. Documents

    1. Fire System Maintenance Log (Annexure-1)
    2. Fire Drill Participation Record (Annexure-2)
    3. Fire Incident Log (Annexure-3)

    8. References

    • Factory Act, 1948 – Fire Safety Section
    • NFPA 10 – Portable Fire Extinguishers
    • ICH Q7 – Section 13 (Environmental Protection and Safety)

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Fire System Maintenance Log

    Date Location Device Status Remarks Checked By
    12/04/2025 Solvent Storage Smoke Detector OK Functional

    Annexure-2: Fire Drill Participation Record

    Date Block No. of Participants Drill Type Remarks
    10/04/2025 API Block-B 32 Evacuation Drill Successfully Completed

    Annexure-3: Fire Incident Log

    Date Area Type Root Cause Action Taken CAPA Ref
    05/04/2025 Solvent Recovery Spark at panel Loose wire Repaired & Inspected CAPA-054

    Revision History:

    Revision Date Revision No. Details Reason Approved By
    01/01/2022 1.0 Initial SOP Release Regulatory Requirement QA Head
    13/04/2025 2.0 Annexures and Drill Details Added Audit Recommendation QA Head
    See also  API Manufacturing: SOP for Process Yield Calculation and Documentation - V 2.0
    API Manufacturing V 2.0 Tags:API batch record, API BMR, API calibration, API centrifuge, API cleaning, API crystallization, API deviation, API documentation, API drying, API equipment cleaning, API filtration, API GMP compliance, API granulation, API hold time, API impurities, API line clearance, API manufacturing, API process, API quality control, API reactor, API sampling, API solvent handling, API validation, API waste disposal, API yield

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    Standard Operating Procedures V 1.0

    • Aerosols
    • Analytical Method Development
    • Bioequivalence Bioavailability Study
    • Capsule Formulation
    • Clinical Studies
    • Creams
    • Data Integrity
    • Dental Dosage Forms
    • Drug Discovery
    • Environment, Health and Safety
    • Formulation Development
    • Gels
    • Good Distribution Practice
    • Good Warehousing Practices
    • In-Process Control
    • Injectables
    • Liquid Orals
    • Liposome and Emulsion Formulations
    • Lotions
    • Lyophilized Products
    • Maintenance Dept.
    • Medical Devices
    • Metered-Dose Inhaler
    • Microbiology Testing
    • Nanoparticle Formulation
    • Nasal Spray Formulations
    • Nebulizers
    • Ocular (Eye) Dosage Forms
    • Ointments
    • Otic (Ear) Dosage Forms
    • Pharmacovigilance
    • Powder & Granules
    • Purchase Departments
    • Quality Assurance
    • Quality Control
    • Raw Material Stores
    • Regulatory Affairs
    • Tablet Manufacturing
    • Rectal Dosage Forms
    • Transdermal Patches
    • Vaginal Dosage Forms
    • Validations and Qualifications

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    NEW! Revised SOPs – V 2.0

    • Aerosols V 2.0
    • Analytical Method Development V 2.0
    • API Manufacturing V 2.0
    • BA-BE Studies V 2.0
    • Biosimilars V 2.0
    • Capsules V 2.0
    • Creams V 2.0
    • Elixers V 2.0
    • Gels V 2.0
    • Injectables V 2.0
    • Ointments V 2.0
    • Raw Material Warehouse V 2.0
    • Tablet Manufacturing V2.0

    New Publication: A must for All.

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