Standard Operating Procedure for Temperature and Humidity Monitoring

1) Purpose

This SOP outlines the procedures for monitoring temperature and humidity levels in pharmaceutical manufacturing and storage areas to ensure product quality and compliance with regulatory requirements.

2) Scope

This SOP applies to all areas within the pharmaceutical facility where temperature and humidity monitoring are critical to maintaining product integrity.

3) Responsibilities

The Facilities or Engineering department is responsible for monitoring temperature and humidity levels. Quality Assurance (QA) oversees compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Monitoring Locations

1. Identify critical areas and equipment requiring temperature and humidity monitoring based on risk assessments and regulatory guidelines.
2. Install calibrated monitoring devices (e.g., data loggers, sensors) at designated locations.

4.2 Monitoring Frequency

1. Establish monitoring frequencies based on product requirements, storage conditions, and regulatory standards.
2. Record temperature and humidity readings at scheduled intervals (e.g., hourly, daily).

4.3 Monitoring Procedures

1. Check and calibrate monitoring devices regularly according to validated procedures.
2. Ensure monitoring devices are placed in locations representative of actual temperature and humidity conditions.

4.4 Alarm System

1. Implement an alarm system to alert personnel of temperature and humidity excursions outside acceptable limits.
2. Define procedures for responding to alarms, including immediate investigation and corrective actions.

4.5 Data Management

1. Record temperature and humidity data accurately and promptly in designated logbooks or electronic systems.
2. Maintain data integrity and ensure records are readily available for review by QA and regulatory inspections.

4.6 Trend Analysis and Reporting

1. Regularly analyze temperature and humidity data trends to identify potential issues or deviations.
2. Generate trend reports and communicate findings to relevant departments for corrective actions and continuous improvement.

4.7 Equipment Maintenance

1. Maintain and calibrate monitoring equipment according to manufacturer specifications and validated procedures.
2. Document equipment maintenance activities and ensure traceability of calibration certificates.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Temperature and Humidity Monitoring Plan, Calibration Records, Alarm Logs, Trend Analysis Reports

7) Reference, if any

Regulatory guidelines such as EU GMP Annex 1 Manufacture of Sterile Medicinal Products, ICH Q1A Stability Testing Guidelines, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

8) SOP Version

Version 1.0