Standard Operating Procedure for Storage Conditions Monitoring

Purpose

The purpose of this SOP is to establish procedures for the monitoring and control of storage conditions for pharmaceutical products to ensure compliance with Good Distribution Practice (GDP) guidelines and maintain product quality and integrity.

Scope

This SOP applies to all personnel involved in the storage and monitoring of pharmaceutical products within the warehouse or storage facility.

Responsibilities

• The Warehouse Management Team is responsible for maintaining appropriate storage conditions and monitoring temperature and humidity levels.
• The Quality Assurance (QA) Department is responsible for establishing and monitoring compliance with storage condition requirements.
• The Quality Control (QC) Department is responsible for conducting periodic checks and inspections to ensure proper storage conditions.

Procedure

1. Storage Area Design and Setup:
   • Design storage areas to meet regulatory requirements and product-specific storage conditions.
   • Install temperature and humidity monitoring devices in critical storage areas.
2. Temperature and Humidity Monitoring:
   • Regularly monitor and record temperature and humidity levels in all storage areas.
   • Calibrate monitoring devices according to established schedules and procedures.
3. Alarm Systems and Alerts:
   • Implement alarm systems to alert personnel of temperature or humidity excursions outside acceptable limits.
   • Establish procedures for responding to alarms, including corrective actions and documentation of incidents.
4. Storage Condition Mapping:
   • Conduct periodic temperature and humidity mapping studies to assess uniformity and stability of storage conditions.
   • Identify hot spots or areas of temperature variability and take corrective actions as necessary.
5. Record keeping and Documentation:
   • Maintain accurate records of temperature and humidity monitoring activities, including data logs and calibration records.
   • Document any deviations from acceptable storage conditions and the actions taken to address them.
6. Training and Awareness:
   • Provide training to personnel involved in storage operations on the importance of maintaining proper storage conditions and monitoring requirements.
   • Promote awareness of storage condition monitoring procedures through regular communication and updates.

Abbreviations

• QA – Quality Assurance
• QC – Quality Control
• GDP – Good Distribution Practice

Documents

Reference documents related to storage conditions monitoring may include:

• Standard operating procedures (SOPs)
• Temperature and humidity monitoring logs
• Storage condition mapping reports
• Calibration certificates
• Incident reports

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0