Standard Operating Procedure for Maintenance of Building and Facilities

1) Purpose

The purpose of this SOP is to establish the procedures for the routine maintenance of buildings and facilities to ensure a safe, functional, and compliant environment for pharmaceutical manufacturing and related activities.

2) Scope

This SOP applies to all buildings, utilities, and facilities within the pharmaceutical manufacturing site, including structural elements, utilities (electrical, plumbing, HVAC), and exterior areas.

3) Responsibilities

The Facility Management Department is responsible for implementing and adhering to this SOP. The Maintenance Team is responsible for executing maintenance activities.

4) Procedure

1. Maintenance Schedule Planning
   1. Develop a comprehensive maintenance schedule covering all buildings and facilities based on criticality, regulatory requirements, manufacturer recommendations, and operational history.
   2. Assign specific maintenance tasks to qualified personnel.
   3. Document the schedule and ensure it is communicated to relevant departments.
2. Preventive Maintenance Tasks
   1. Inspect and maintain structural integrity, including roofs, walls, and flooring.
   2. Check and service utilities such as electrical systems, plumbing, and HVAC systems.
   3. Inspect and clean exterior areas, including parking lots and drainage systems.
   4. Ensure compliance with safety and environmental regulations.
3. Corrective Maintenance Procedures
   1. Address any building or facility issues promptly to prevent disruption of operations.
   2. Diagnose the root cause of problems and determine necessary repairs.
   3. Execute repairs using approved methods and materials.
   4. Conduct post-repair inspections to verify effectiveness.
4. Record Keeping
   1. Maintain detailed records of all maintenance activities, including preventive and corrective maintenance tasks.
   2. Document inspection reports, maintenance logs, and repair records.
   3. Archive records for future reference and regulatory inspections.

5) Abbreviations, if any

None

6) Documents, if any

Maintenance Schedules, Inspection Reports, Maintenance Records, Building Plans

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for maintenance of pharmaceutical facilities.

8) SOP Version

Version 1.0