Standard Operating Procedure for Corrective Maintenance Procedures

1) Purpose

The purpose of this SOP is to establish the procedures for identifying, reporting, and correcting equipment and system failures in the pharmaceutical industry to ensure minimal downtime and compliance with regulatory requirements.

2) Scope

This SOP applies to all equipment and systems used in the pharmaceutical manufacturing process that may require corrective maintenance in the event of a failure or malfunction.

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. Identification of Issues
   1. Monitor equipment and systems regularly for any signs of malfunction or failure.
   2. Report any issues immediately to the Maintenance Department.
   3. Document the nature of the issue, including the date and time of discovery, in the maintenance log.
2. Assessment and Planning
   1. Assess the reported issue to determine the cause and extent of the problem.
   2. Plan corrective actions based on the assessment findings, including necessary resources and time required.
   3. Prioritize corrective actions based on the severity and impact on production.
3. Execution of Corrective Maintenance
   1. Perform the necessary corrective maintenance tasks using approved tools and procedures.
   2. Document each maintenance activity, including date, tasks performed, and personnel involved.
   3. Test the equipment or system after maintenance to ensure