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

1. 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.
2. 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.
3. 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