Standard Operating Procedure for Maintenance of Environmental Monitoring Systems

1) Purpose

The purpose of this SOP is to establish the procedures for the routine maintenance of environmental monitoring systems to ensure accurate monitoring and recording of environmental conditions in pharmaceutical manufacturing and storage areas.

2) Scope

This SOP applies to all environmental monitoring systems used in pharmaceutical manufacturing facilities, including sensors, data loggers, and monitoring software.

3) Responsibilities

The Quality Control Department or Facility Management 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 maintenance schedule based on equipment 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. Perform routine inspections of environmental monitoring systems according to the schedule.
   2. Calibrate sensors and data loggers to ensure accuracy of measurements.
   3. Verify proper functioning of communication interfaces and alarm systems.
   4. Check and replace batteries in wireless sensors as needed.
3. Corrective Maintenance Procedures
   1. Address any deviations or failures in environmental monitoring promptly.
   2. Diagnose the root cause of issues and determine necessary repairs.
   3. Replace malfunctioning components using approved spare parts and procedures.
   4. Validate system accuracy and functionality post-repair.
4. Record Keeping
   1. Maintain detailed records of all maintenance activities, including preventive and corrective maintenance tasks.
   2. Document calibration records, maintenance logs, 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, Calibration Records, Maintenance Records, Equipment Manuals

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for environmental monitoring in pharmaceutical facilities.

8) SOP Version

Version 1.0