Standard Operating Procedure for Stability Chamber Qualification

Purpose

The purpose of this SOP is to establish the procedures for the qualification of stability chambers used in the pharmaceutical industry.

Scope

This SOP applies to all stability chambers used for the storage of pharmaceutical products at various conditions to assess their stability over time.

Responsibilities

• Quality Assurance: Responsible for overall oversight and approval of the stability chamber qualification process.
• Quality Control: Responsible for executing the qualification protocols and conducting necessary testing.
• Engineering: Responsible for maintenance and calibration of stability chambers.

Procedure

1. Prepare a qualification protocol outlining the acceptance criteria and testing procedures for stability chambers.
2. Perform an Installation Qualification (IQ) to ensure that the stability chamber is installed correctly and meets the manufacturer’s specifications.
3. Conduct an Operational Qualification (OQ) to verify that the stability chamber operates within defined parameters under normal operating conditions.
4. Execute a Performance Qualification (PQ) to demonstrate that the stability chamber consistently maintains the required temperature and humidity levels over an extended period.
5. Document all test results, deviations, and corrective actions taken during the qualification process.
6. Review and approve the qualification report.
7. Periodically re-qualify stability chambers according to the defined schedule.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Stability Chamber Qualification Protocol
• Installation Qualification Report
• Operational Qualification Report
• Performance Qualification Report

Reference

No external references are used in this SOP.

SOP Version

Version 1.0