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