SOP Guide for Pharma

SOP for Emergency Preparedness and Response

Auditor

SOP for Emergency Preparedness and Response

SOP for Emergency Preparedness and Response

1) Purpose

To establish procedures for emergency preparedness, response, and recovery to mitigate potential risks and ensure the safety of personnel and resources within the pharmaceutical manufacturing facility.

2) Scope

This SOP applies to all employees, contractors, and visitors within the pharmaceutical manufacturing facility.

3) Responsibilities

Emergency Response Team: Responsible for developing and implementing emergency response plans and coordinating response efforts.
Employees: Responsible for following emergency procedures, reporting incidents, and participating in drills.
Facility Management: Responsible for providing resources, training, and support for emergency response activities.
External Emergency Services: Responsible for providing support and assistance during emergencies as needed.

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4) Procedure

  1. Emergency Planning:
    1. Conduct risk assessments to identify potential hazards and scenarios requiring emergency response.
    2. Develop emergency response plans (ERP) for various scenarios, including fire, chemical spills, medical emergencies, etc.
    3. Establish communication protocols and emergency contacts.
  2. Emergency Response:
    1. Activate ERP in case of emergency, including alerting personnel and initiating response actions.
    2. Evacuate personnel to safe assembly points if necessary.
    3. Implement measures to contain and mitigate emergencies, such as firefighting, spill control, or
medical response.
  • Post-Emergency Recovery:
    1. Assess and document the effectiveness of emergency response actions.
    2. Restore operations and conduct debriefings to review the incident and identify lessons learned.
    3. Update ERP based on feedback and findings from emergency exercises and actual incidents.
  • Training and Drills:
    1. Provide regular training to employees on emergency procedures and roles.
    2. Conduct drills and exercises to test the effectiveness of ERP and familiarize personnel with response actions.
    3. Review and update training materials and scenarios based on drill outcomes.

    • 5) Abbreviations, if any

    SOP – Standard Operating Procedure

    ERP – Emergency Response Plan

    6) Documents, if any

    • Emergency Response Plans (ERPs)
    • Emergency Contact List
    • Training Records
    • Incident Reports

    7) Reference, if any

    OSHA Emergency Action Plan (EAP) Requirements

    8) SOP Version

    Version 1.0

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