Standard Operating Procedure for Temperature Monitoring
Purpose
The purpose of this SOP is to establish procedures for monitoring and maintaining temperature-controlled storage areas in the pharmaceutical warehouse.
Scope
This SOP applies to all personnel responsible for monitoring temperature-controlled storage areas and handling temperature-sensitive pharmaceutical products.
Responsibilities
- Warehouse Manager: Overall responsibility for ensuring compliance with temperature monitoring SOP.
- Temperature Monitoring Personnel: Responsible for regularly monitoring and recording temperatures in designated storage areas.
- Quality Assurance: Responsible for reviewing temperature monitoring records and addressing any deviations from specified temperature ranges.
- Facilities Management: Responsible for maintaining temperature-controlled storage equipment and addressing any issues promptly.
Procedure
- Temperature Monitoring Equipment:
- Ensure that temperature monitoring equipment, such as data loggers or sensors, is calibrated and functioning properly.
- Place temperature monitoring devices strategically throughout temperature-controlled storage areas to capture accurate readings.
- Regularly inspect and maintain temperature monitoring equipment to ensure reliability.
- Temperature Monitoring:
- Monitor temperatures in temperature-controlled storage areas at regular intervals, as specified by SOP.
- Record temperature readings accurately and legibly on designated temperature monitoring logs or electronic systems.
- Immediately investigate any temperature deviations outside of specified ranges and document corrective actions taken.
- Temperature Maintenance:
- Ensure that temperature-controlled storage areas are properly insulated and sealed to maintain consistent temperatures.
- Monitor environmental factors such as humidity levels and ventilation to prevent temperature fluctuations.
- Implement backup power systems or contingency plans to maintain temperature control in the event of power outages or equipment failures.
- Temperature Deviation Management:
- Develop procedures for managing temperature deviations, including protocols for product disposition and notification of relevant personnel.
- Investigate root causes of temperature deviations and implement corrective actions to prevent recurrence.
- Document all temperature deviation incidents and corrective actions taken for review and audit purposes.
Abbreviations
- SOP: Standard Operating Procedure
Documents
- Temperature Monitoring Logs
- Calibration Certificates
- Corrective Action Reports
SOP Version
Version 1.0