Standard Operating Procedure for Temperature and Humidity Monitoring Equipment
1) Purpose
The purpose of this SOP is to establish procedures for the calibration, operation, and maintenance of temperature and humidity monitoring equipment used in the manufacturing environment of dental dosage forms to ensure compliance with environmental control requirements.
2) Scope
This SOP applies to all temperature and humidity monitoring activities conducted in manufacturing areas producing dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Facilities Management Department is responsible for executing temperature and humidity monitoring procedures. The Quality Assurance (QA) Department is responsible for verifying compliance with this SOP.
4) Procedure
4.1 Equipment Calibration
4.1.1 Calibrate temperature and humidity monitoring equipment regularly according to manufacturer’s specifications and calibration schedules.
4.1.2 Record calibration details including dates, results, and adjustments made.
4.2 Equipment Setup and Placement
4.2.1 Install temperature and humidity monitoring equipment in designated critical areas (e.g., manufacturing rooms, storage areas).
4.2.2 Ensure proper placement to accurately capture environmental conditions.
4.3 Monitoring Conditions
4.3.1 Monitor temperature and humidity levels continuously or at specified intervals as per regulatory requirements and operational needs.
4.3.2 Use validated monitoring devices to capture and record data effectively.
4.4 Alarm and Notification Systems
4.4.1 Set up alarm systems to alert personnel to temperature or humidity deviations outside acceptable ranges.
4.4.2 Document alarm events and corrective actions taken in response to deviations.
4.5 Data Recording and Reporting
4.5.1 Record temperature and humidity monitoring data accurately in designated logbooks or electronic systems.
4.5.2 Generate periodic reports summarizing monitoring results and trends.
4.6 Equipment Maintenance
4.6.1 Perform routine maintenance and cleaning of temperature and humidity monitoring equipment.
4.6.2 Replace sensors or components as needed to maintain equipment functionality.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Calibration Certificates
Temperature and Humidity Monitoring Records
Alarm Logs
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
International Conference on Harmonisation (ICH) guidelines for environmental control
8) SOP Version
Version 1.0
