Standard Operating Procedure for Emergency Shutdown and Restart Procedures

1) Purpose

The purpose of this SOP is to define the steps and protocols for safely shutting down and restarting manufacturing equipment in case of emergencies to protect personnel and minimize equipment damage.

2) Scope

This SOP applies to all personnel involved in emergency response and equipment operation within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Emergency Response Team

• Execute shutdown procedures during emergencies.
• Coordinate with operations and safety personnel.

3.2 Operations Personnel

• Follow emergency shutdown protocols as directed.
• Assist in equipment inspection and restart procedures.

4) Procedure

4.1 Emergency Shutdown

1. Activate emergency stop controls or shutdown switches.
2. Secure hazardous materials and equipment to prevent further risks.
3. Evacuate personnel to safe assembly points.

4.2 Equipment Inspection

1. Assess equipment condition post-emergency.
2. Identify any damage or potential hazards.

4.3 Restart Procedure

1. Inspect and repair equipment as necessary.
2. Coordinate restart with maintenance and operations teams.
3. Perform system checks and verify normal operation.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

• Emergency Response Plan
• Shutdown and Restart Checklist
• Equipment Inspection Reports

7) Reference, if any

OSHA 29 CFR 1910.38: Emergency Action Plans
ICH Q9: Quality Risk Management

8) SOP Version

Version 1.0