SOP for Emergency Preparedness and Response

Standard Operating Procedure for Emergency Preparedness and Response

1) Purpose

This SOP outlines the procedures for responding to emergencies, including fire, chemical spills, and equipment failures, in GMP-regulated facilities. The goal is to ensure safety and minimize the impact on production.

2) Scope

This SOP applies to all personnel working in GMP-regulated areas at [Company Name].

3) Responsibilities

Employees: Report emergencies immediately and follow the emergency response protocols.
Supervisors: Lead the emergency response and ensure the safety of all personnel.
Quality Assurance (QA): Document all incidents and ensure compliance with regulatory reporting requirements.

4) Procedure

4.1 Emergency Preparedness

4.1.1 Emergency Drills

Conduct regular emergency drills, including fire evacuation, chemical spill response, and equipment failure scenarios. Ensure all personnel participate in drills at least once per year.
Document the results of each drill, including the response time and areas for improvement, in the emergency preparedness log.

4.1.2 Emergency Equipment

Ensure that all emergency equipment, including fire extinguishers, spill kits, and first aid supplies, is accessible and in good working order. Inspect emergency equipment monthly and document the inspection in the equipment log.

4.2 Emergency Response Procedures

4.2.1 Fire

Response

In the event of a fire, activate the nearest fire alarm and evacuate the building immediately. Follow the designated evacuation routes and assemble at the designated meeting point.
Only trained personnel should attempt to use fire extinguishers to contain small fires.

4.2.2 Chemical Spill Response

For minor chemical spills, use the spill kit to contain and clean up the spill. Dispose of contaminated materials as per the hazardous waste disposal SOP.
For major spills, evacuate the area and contact the EHS (Environmental, Health, and Safety) team for assistance. Document all spills in the incident log.

4.2.3 Equipment Failure

If critical production equipment fails, stop production immediately and notify the supervisor. Record the equipment failure in the maintenance log and submit for QA review.
Do not resume production until the equipment has been repaired and approved for use by QA.

4.3 Post-Emergency Activities

4.3.1 Incident Reporting

Document all emergency incidents, including fires, spills, and equipment failures, in the incident log. Provide a detailed description of the event, the response, and any corrective actions taken.
Submit the incident report to QA and EHS for review and follow-up.

4.3.2 Corrective Actions

Following any emergency incident, implement corrective actions to prevent recurrence. Review the incident during the next safety meeting and update SOPs as needed.

5) Abbreviations, if any

QA: Quality Assurance
EHS: Environmental, Health, and Safety

6) Documents, if any

Emergency Preparedness Log
Incident Log
Equipment Log

7) References, if any

Internal SOP for hazardous waste disposal
Internal SOP for fire safety

8) SOP Version

Version 1.0

Annexure

1. Incident Log Template


  
    Date
    Incident Type
    Location
    Description
    Response Actions
    QA Approval
  
  
    DD/MM/YYYY
    Fire/Chemical Spill/Equipment Failure
    Room/Facility
    Detailed Description
    Response Taken
    QA Name

Date	Incident Type	Location	Description	Response Actions	QA Approval
DD/MM/YYYY	Fire/Chemical Spill/Equipment Failure	Room/Facility	Detailed Description	Response Taken	QA Name