SOP-24: Quality Metrics defines a structured, GMP-compliant system for monitoring and evaluating quality performance through defined quality metrics. The SOP ensures that quality data is collected, assessed, and used as input for management decision-making and the annual Quality Management Review (QMR).
 
The document is professionally written and pre-filled (~95% complete), requiring only company-specific information before approval.
 
Developed for biotech and pharmaceutical organisations, the SOP describes how quality metrics are initiated, measured, evaluated, and documented on a quarterly basis. It clearly assigns responsibilities to management and the Quality Manager and supports continuous improvement of the Quality Management System.
 
Includes:
• Defined quality metrics and performance indicators
• Quarterly evaluation process
• Roles and responsibilities for management and QA
• Documentation and decision recording requirements
• Integration with the annual Quality Management Review (QMR)
• Reference to supporting log sheet (SOP-24.1)
 
Why it matters:
Regulators expect companies to actively monitor quality performance and use objective data to drive improvements. This SOP provides a clear, inspection-ready framework for tracking quality trends and demonstrating effective management oversight.