Standard Operating Procedure for Calibration and Maintenance of Monitoring Devices

Purpose

The purpose of this SOP is to establish procedures for the calibration and maintenance of monitoring devices used for temperature and humidity monitoring in pharmaceutical storage areas, ensuring accuracy and reliability in compliance with Good Distribution Practice (GDP) guidelines.

Scope

This SOP applies to all personnel responsible for the calibration and maintenance of monitoring devices, including temperature sensors, data loggers, and humidity meters, used in pharmaceutical storage areas.

Responsibilities

• The Facilities Management Team is responsible for the calibration and maintenance of monitoring devices in pharmaceutical storage areas.
• The Quality Assurance (QA) Department is responsible for overseeing the calibration and maintenance activities and ensuring compliance with GDP requirements.
• The Calibration Technician is responsible for performing calibration procedures and maintaining calibration records.

Procedure

1. Calibration Schedule:
   • Establish a calibration schedule for monitoring devices based on manufacturer recommendations, regulatory requirements, and risk assessment.
   • Record calibration due dates and maintain a calibration schedule to ensure timely calibration activities.
2. Calibration Procedure:
   • Perform calibration of monitoring devices using calibrated reference standards or traceable calibration equipment.
   • Follow manufacturer instructions and standard operating procedures for calibration procedures, including adjustments and verifications.
3. Calibration Records:
   • Document all calibration activities, including calibration dates, results, adjustments made, and calibration certificates.
   • Maintain calibration records in a secure and accessible location for audit and review purposes.
4. Maintenance and Troubleshooting:
   • Conduct routine maintenance checks on monitoring devices to ensure proper functioning and accuracy.
   • Address any issues or malfunctions promptly through troubleshooting and corrective actions.
5. Calibration Out-of-Tolerance:
   • Take immediate action if monitoring devices are found to be out of tolerance during calibration, including re-calibration or replacement if necessary.
   • Investigate root causes of calibration failures and implement corrective and preventive actions to prevent recurrence.

Abbreviations

• QA – Quality Assurance
• GDP – Good Distribution Practice

Documents

Reference documents related to calibration and maintenance of monitoring devices may include:

• Calibration schedules
• Calibration procedures
• Calibration records
• Manufacturer manuals
• Corrective and preventive action reports

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0