SOP Guide for Pharma

API Manufacturing: SOP for Emergency Evacuation Procedure in API Plant – V 2.0

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API Manufacturing: SOP for Emergency Evacuation Procedure in API Plant – V 2.0

Standard Operating Procedure for Emergency Evacuation Procedure in API Plant

Department API Manufacturing
SOP No. SOP/API/201/2025
Supersedes SOP/API/201/2022
Page No. Page 1 of 12
Issue Date 14/04/2025
Effective Date 16/04/2025
Review Date 14/04/2026

1. Purpose

To establish a systematic approach for safe and effective evacuation of personnel in the event of an emergency such as fire, gas leak, explosion, or natural disaster within the API manufacturing facility, minimizing risk to human life and ensuring compliance with safety regulations.

2. Scope

This SOP applies to all employees,

visitors, contractors, and personnel present within the premises of the API manufacturing plant during working and non-working hours. It covers emergency detection, evacuation alerts, assembly area coordination, and post-evacuation accountability.

3. Responsibilities

  • Emergency Response Team (ERT): Initiates and manages the evacuation process.
  • Security Staff: Activate alarms and control access gates and emergency exits.
  • Departmental Wardens: Guide employees toward designated evacuation routes.
  • Employees: Follow evacuation instructions calmly and assemble at the designated safe zone.
  • QA Officer: Ensures documentation of the event, confirms SOP compliance, and reports deviations.
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4. Accountability

The EHS (Environment, Health & Safety) Manager is accountable for ensuring proper training, regular drills, and execution of the evacuation procedure as per this SOP.

5. Procedure

5.1 Emergency Identification

  1. Any person identifying an emergency (fire, chemical leak, structural hazard) shall immediately inform the control room/security desk.
  2. The emergency shall be verified by the shift in-charge or ERT and declared based on severity.
  3. Use of fire alarm systems, sirens, or public address systems to announce evacuation.

5.2 Alarm Activation and Alert

  1. Security team shall:
    • Trigger the alarm system and make a public announcement of the emergency code.
    • Inform local fire department and medical authorities if required.

5.3 Evacuation Process

  1. All employees must:
    • Cease operations immediately
    • Switch off electrical equipment (if safe)
    • Proceed to the nearest safe exit route
  2. Departmental Wardens shall:
    • Guide team members along evacuation paths
    • Check and close lab/room doors (if time permits)
    • Carry department roll-call list to assembly point
  3. Use of lifts is strictly prohibited during evacuation.

5.4 Assembly Point and Headcount

  1. All employees shall gather at their designated assembly area (see Annexure-1: Site Map).
  2. Wardens shall conduct a headcount and submit a report to the ERT leader.
  3. Missing persons, injuries, or irregularities must be reported to the ERT immediately.
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5.5 All-Clear Declaration and Return

  1. ERT, in coordination with safety and emergency services, shall assess the situation and declare it safe.
  2. QA shall verify that facility checks and utility systems are functioning safely.
  3. Return to workplace shall be allowed only after ERT issues the ‘All Clear’ announcement.

5.6 Mock Drills and Training

  1. Mock evacuation drills shall be conducted quarterly as per training calendar (Annexure-2).
  2. Drill performance, timings, and observations shall be documented in the Evacuation Drill Log (Annexure-3).

5.7 Post-Evacuation Review

  1. QA and EHS shall conduct a post-event review using the Evacuation Review Form (Annexure-4).
  2. Observations, gaps, and recommendations shall be documented and followed up via CAPA.

6. Abbreviations

  • ERT: Emergency Response Team
  • GMP: Good Manufacturing Practices
  • QA: Quality Assurance
  • EHS: Environment, Health & Safety
  • CAPA: Corrective and Preventive Action

7. Documents

  1. Site Map with Assembly Points – Annexure-1
  2. Evacuation Drill Schedule – Annexure-2
  3. Evacuation Drill Log – Annexure-3
  4. Evacuation Review Form – Annexure-4
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8. References

  • Factory Act 1948 – Emergency Preparedness Guidelines
  • OSHA Guidelines for Emergency Action Plans
  • NFPA 101 – Life Safety Code
  • ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Site Map with Assembly Points

A diagram/map showing all emergency exits, fire extinguishers, and primary/secondary assembly areas (to be attached by Safety Officer).

Annexure-2: Evacuation Drill Schedule

Month Planned Date Conducted On Remarks
Q1 15/01/2025 16/01/2025 Completed

Annexure-3: Evacuation Drill Log

Date Time Started Assembly Completed Total Time Taken Issues Observed
16/01/2025 10:00 AM 10:06 AM 6 minutes Blocked corridor

Annexure-4: Evacuation Review Form

Event/Drill Date Reviewer Findings CAPA Required
Drill 16/01/2025 QA Officer Fire alarm delay Yes

Revision History:

Revision Date Revision No. Details Reason Approved By
01/01/2022 1.0 Initial version New SOP QA Head
14/04/2025 2.0 Updated evacuation procedure and annexures Annual Review QA Head
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