Standard Operating Procedure for Maintenance of Production Equipment

1) Purpose

The purpose of this SOP is to establish the procedures for the routine maintenance of production equipment to ensure optimal performance and reliability in the pharmaceutical manufacturing process.

2) Scope

This SOP applies to all production equipment used in pharmaceutical manufacturing, including but not limited to blending machines, reactors, and encapsulation machines.

3) Responsibilities

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

4) Procedure

1. Maintenance Schedule Planning
   1. Develop a maintenance schedule based on equipment criticality, 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. Perform routine inspections of production equipment according to the schedule.
   2. Check for signs of wear, leaks, or other abnormalities.
   3. Perform lubrication, cleaning, and adjustments as needed.
   4. Replace consumable parts based on usage and manufacturer recommendations.
3. Corrective Maintenance Procedures
   1. Address equipment breakdowns or malfunctions promptly.
   2. Diagnose the root cause of the issue and determine necessary repairs.
   3. Perform repairs using approved spare parts and procedures.
   4. Test equipment after repairs to ensure proper functionality.
4. Record Keeping
   1. Maintain detailed records of all maintenance activities, including preventive and corrective maintenance tasks.
   2. Document equipment condition assessments and any deviations from standard operating conditions.
   3. Archive records for future reference and regulatory inspections.

5) Abbreviations, if any

None

6) Documents, if any

Maintenance Schedules, Maintenance Logs, Equipment Manuals

7) Reference, if any

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

8) SOP Version

Version 1.0