Standard Operating Procedure for Maintenance of Safety Equipment

1) Purpose

The purpose of this SOP is to establish the procedures for the maintenance of safety equipment to ensure a safe working environment for employees in pharmaceutical manufacturing facilities.

2) Scope

This SOP applies to all safety equipment within pharmaceutical manufacturing facilities, including personal protective equipment (PPE), safety showers, eyewash stations, and emergency alarms.

3) Responsibilities

The Facility Management Department is responsible for implementing and adhering to this SOP. The Safety Committee is responsible for oversight and ensuring compliance with safety regulations.

4) Procedure

1. Inspection and Testing
   1. Regularly inspect safety equipment for damage, functionality, and compliance with safety standards.
   2. Test functionality of emergency alarms, eyewash stations, and safety showers according to regulatory requirements.
2. Preventive Maintenance Tasks
   1. Service and maintain safety equipment as per manufacturer guidelines and regulatory requirements.
   2. Replace worn-out or damaged parts promptly.
   3. Calibrate safety alarms and sensors regularly.
3. Corrective Maintenance Procedures
   1. Address reported safety equipment issues immediately.
   2. Diagnose the cause of malfunctions and determine necessary repairs.
   3. Replace faulty components using approved spare parts and procedures.
   4. Conduct operational tests post-repair to ensure proper functionality.
4. Record Keeping
   1. Maintain detailed records of all maintenance activities related to safety equipment.
   2. Document inspection reports, maintenance logs, repair records, and calibration certificates.
   3. Archive records for future reference and regulatory inspections.

5) Abbreviations, if any

PPE: Personal Protective Equipment

6) Documents, if any

Inspection Reports, Maintenance Logs, Calibration Certificates, Safety Equipment Manuals

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for maintenance and testing of safety equipment in pharmaceutical manufacturing facilities.

8) SOP Version

Version 1.0