Standard Operating Procedure for Health and Safety in Maintenance

1) Purpose

The purpose of this SOP is to establish guidelines for ensuring health and safety during maintenance activities to protect personnel, equipment, and the environment in pharmaceutical manufacturing facilities.

2) Scope

This SOP applies to all maintenance activities conducted within pharmaceutical manufacturing facilities, including equipment, utilities, facilities, and safety systems.

3) Responsibilities

The Facility Management Department is responsible for implementing and adhering to this SOP. The Safety Officer collaborates with the Maintenance Supervisor to ensure health and safety in maintenance activities.

4) Procedure

1. Risk Assessment
   1. Conduct risk assessments before performing maintenance tasks.
   2. Identify potential hazards, such as electrical, chemical, mechanical, and ergonomic risks.
   3. Implement controls to mitigate risks, including lockout/tagout procedures.
2. Personal Protective Equipment (PPE)
   1. Ensure personnel use appropriate PPE for specific maintenance tasks.
   2. Inspect and maintain PPE regularly to ensure effectiveness.
3. Training and Qualification
   1. Provide training to personnel on safe work practices and procedures.
   2. Verify competency through qualifications and certifications.
4. Emergency Preparedness
   1. Establish emergency response procedures for maintenance-related incidents.
   2. Ensure personnel are trained in emergency procedures and evacuation routes.
5. Continuous Improvement
   1. Regularly review and update safety procedures based on incident reports and lessons learned.
   2. Promote a culture of safety and encourage reporting of near misses and hazards.

5) Abbreviations, if any

PPE: Personal Protective Equipment

6) Documents, if any

Risk Assessment Reports, PPE Inspection Logs, Training Records, Emergency Response Plans

7) Reference, if any

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

8) SOP Version

Version 1.0