Standard Operating Procedure for Monitoring and Controlling Temperature and Humidity in Storage Areas

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for monitoring and controlling temperature and humidity in storage areas within the pharmaceutical manufacturing facility to maintain product quality and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in temperature and humidity monitoring within the pharmaceutical manufacturing facility. It covers procedures for monitoring equipment, data recording, alarm management, and corrective actions.

3) Responsibilities

– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Facilities Management: Maintains monitoring equipment and ensures environmental conditions are within specified limits.
– Production Department: Monitors storage areas and takes corrective actions as necessary to maintain environmental conditions.

4) Procedure

4.1 Monitoring Equipment
4.1.1 Install calibrated temperature and humidity monitoring devices in critical storage areas.
4.1.2 Ensure monitoring devices are capable of continuous recording and alarm generation for out-of-specification conditions.
4.2 Monitoring Frequency
4.2.1 Establish a monitoring schedule based on risk assessment and regulatory requirements (e.g., daily, weekly).
4.2.2 Monitor and record temperature and humidity levels at specified intervals during each monitoring period.
4.3 Data Recording
4.3.1 Record temperature and humidity data promptly and accurately in designated logbooks or electronic systems.
4.3.2 Include information such as monitoring date, time, location, and environmental conditions.
4.4 Alarm Management
4.4.1 Set alarm thresholds based on acceptance criteria and regulatory guidelines.
4.4.2 Immediately investigate and resolve alarm triggers, documenting all corrective actions taken.
4.5 Corrective Actions
4.5.1 Implement corrective actions for any deviations from acceptable temperature and humidity ranges.
4.5.2 Document all corrective actions, including root cause analysis and preventive measures.
4.6 Documentation
4.6.1 Maintain comprehensive records of temperature and humidity monitoring activities, including logs, reports, and alarm histories.
4.6.2 Ensure that all records are reviewed and approved by the QA department.
4.7 Reporting
4.7.1 Prepare periodic reports summarizing temperature and humidity monitoring results, alarms, and corrective actions.
4.7.2 Submit reports to the QA department for review and archiving.
4.8 Calibration
4.8.1 Calibrate monitoring equipment regularly according to defined schedules and procedures.
4.8.2 Document calibration activities and maintain calibration certificates for inspection purposes.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents, if any

– Temperature and Humidity Monitoring Logs
– Alarm Logs
– Calibration Certificates

7) Reference, if any (continued)

– FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
– ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0