Standard Operating Procedure for Humidity Monitoring
Purpose
The purpose of this SOP is to establish guidelines for monitoring and maintaining humidity levels in storage areas of the pharmaceutical warehouse.
Scope
This SOP applies to all personnel responsible for monitoring and maintaining humidity levels within designated storage areas.
Responsibilities
- Warehouse Manager: Overall responsibility for compliance with humidity monitoring SOP.
- Facility Maintenance Personnel: Responsible for monitoring and maintaining humidity levels within storage areas.
- Quality Assurance: Responsible for verifying that humidity levels are within acceptable ranges and addressing any deviations.
- Training Coordinator: Responsible for providing training on humidity monitoring procedures to relevant personnel.
Procedure
- Humidity Monitoring Equipment:
- Ensure that humidity monitoring equipment is calibrated and functioning properly.
- Place humidity sensors in strategic locations within storage areas to capture representative readings.
- Check humidity monitoring equipment regularly to ensure accurate measurements.
- Monitoring Frequency:
- Monitor humidity levels at regular intervals according to established schedules.
- Frequency of monitoring may vary depending on the sensitivity of stored products and environmental conditions.
- Record humidity readings along with date, time, and location of measurement.
- Humidity Control:
- Take corrective actions if humidity levels deviate from acceptable ranges.
- Adjust environmental controls such as HVAC systems or dehumidifiers to maintain optimal humidity levels.
- Document any interventions or adjustments made to control humidity.
- Record Keeping:
- Maintain records of humidity measurements and control actions taken in a designated logbook or electronic database.
- Review humidity records regularly to identify trends or patterns that may require further investigation.
- Store humidity records securely for future reference or audit purposes.
Abbreviations
- SOP: Standard Operating Procedure
- HVAC: Heating, Ventilation, and Air Conditioning
Documents
- Humidity Monitoring Logbook
- Calibration Certificates for Monitoring Equipment
SOP Version
Version 1.0
