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
- Use flameproof electrical fittings in flammable zones.
- Ensure solvents are stored in bonded, grounded, and ventilated enclosures.
- Prohibit use of open flames, smoking, and mobile phones in solvent handling areas.
- Conduct regular preventive maintenance of machines, motors, and exhausts.
- Ensure LOTO (Lock-Out Tag-Out) before repair in flammable zones.
5.2 Fire Detection Systems
- Install fire detectors, smoke sensors, and heat sensors across solvent storage, production floors, and utility areas.
- Check sensor calibration every 6 months and record in the “Fire System Maintenance Log” (Annexure-1).
- Connect all detectors to a centralized fire alarm panel and link with audible/visual alarms.
5.3 Firefighting Equipment and Signage
- Install fire extinguishers (foam, dry chemical, CO₂) at designated points as per NFPA spacing.
- Ensure fire hydrants, hose reels, sand buckets, and emergency showers are clearly labeled and accessible.
- Update location maps and fire exits annually.
5.4 Training and Drills
- Conduct fire mock drills every quarter in each building block.
- Maintain “Fire Drill Participation Record” (Annexure-2).
- Train staff on:
- Emergency response
- Evacuation protocols
- Use of extinguishers and alarm systems
5.5 Fire Emergency Protocol
- 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
- 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
- Fire System Maintenance Log (Annexure-1)
- Fire Drill Participation Record (Annexure-2)
- 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 |