Standard Operating Procedure for Preventive Maintenance Program

1) Purpose

The purpose of this SOP is to establish guidelines for implementing a preventive maintenance program in pharmaceutical manufacturing facilities to ensure the reliability, safety, and longevity of equipment.

2) Scope

This SOP applies to all equipment and systems requiring preventive maintenance within the facility premises.

3) Responsibilities

The Facilities Management Department and designated maintenance personnel are responsible for implementing and adhering to this SOP.

4) Procedure

1. Asset Inventory and Prioritization
   1. Develop an inventory of all critical equipment and systems requiring preventive maintenance.
   2. Prioritize assets based on operational criticality, regulatory requirements, and historical maintenance data.
2. Maintenance Schedule Development
   1. Create a preventive maintenance schedule specifying maintenance tasks, frequencies, and responsible personnel.
   2. Align maintenance activities with equipment manufacturer recommendations, industry best practices, and regulatory requirements.
3. Execution of Preventive Maintenance Tasks
   1. Perform scheduled preventive maintenance tasks according to the established schedule and procedures.
   2. Document maintenance activities, including inspections, lubrications, adjustments, and replacements.
4. Monitoring and Performance Evaluation
   1. Monitor equipment performance and condition indicators to identify potential issues or deterioration.
   2. Evaluate the effectiveness of the preventive maintenance program through performance metrics and feedback.
5. Continuous Improvement
   1. Review and update preventive maintenance procedures based on equipment performance data and lessons learned.
   2. Implement improvements to optimize equipment reliability, efficiency, and compliance.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Equipment Inventory, Preventive Maintenance Schedule, Maintenance Records, Performance Metrics Reports, Improvement Plans

7) Reference, if any

Manufacturer’s maintenance guidelines, regulatory requirements for equipment maintenance in pharmaceutical manufacturing, and industry standards for preventive maintenance programs.

8) SOP Version

Version 1.0