Standard Operating Procedure for Preventive Maintenance Program

1) Purpose

The purpose of this SOP is to establish a systematic approach for the preventive maintenance of equipment and systems in the pharmaceutical industry to ensure their optimal performance, reliability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all equipment and systems used in the pharmaceutical manufacturing process that require regular preventive maintenance to ensure their proper functioning and to prevent unexpected failures.

3) Responsibilities

The Maintenance Department is responsible for implementing and adhering to this SOP. All relevant personnel must be trained on the procedures outlined in this document.

4) Procedure

1. Planning and Scheduling
   1. Identify all equipment and systems requiring preventive maintenance.
   2. Create a maintenance schedule based on manufacturer recommendations, industry standards, and historical data.
   3. Ensure the schedule is accessible to all relevant personnel.
2. Execution of Preventive Maintenance
   1. Perform maintenance tasks as per the schedule using approved tools and procedures.
   2. Document each maintenance activity, including date, tasks performed, and personnel involved.
   3. Address any issues or abnormalities discovered during maintenance immediately.
3. Review and Documentation
   1. Review maintenance records regularly to identify trends and areas for improvement.
   2. Update the maintenance schedule and procedures based on review findings and equipment performance data.

5) Abbreviations, if any

None

6) Documents, if any

Maintenance Logbooks, Equipment Manuals, Maintenance Checklists

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements.

8) SOP Version

Version 1.0