A Risk Index and Data Display for Process Performance in the Pharmaceutical Industry

Area of Science:

• Pharmaceutical Manufacturing
• Process Engineering
• Quality Control

Background:

• Pharmaceutical processes often exhibit skewed or short-tailed data distributions.
• Traditional process performance metrics (means, standard deviations) can be unreliable for such data.
• Accurate process performance assessment is crucial for risk management and continuous improvement.

Purpose of the Study:

• To introduce a novel index and graphical display for quantifying and visualizing pharmaceutical process performance.
• To enable effective risk ranking of manufacturing processes.
• To support evidence-based strategic planning for continuous process improvement.

Main Methods:

• Development of a new process performance index utilizing sample quantiles.
• Creation of a novel graphical display for visualizing process and site comparisons.
• Comparison of observed critical quality attributes (CQAs) variation against specifications.

Main Results:

• The proposed index offers more accurate and reliable performance assessment, especially for skewed data.
• The graphical display effectively compares processes and sites, highlighting potential misleading summaries.
• The tools facilitate identification of processes at greatest risk of failing to meet specifications.

Conclusions:

• The new index and display provide a comprehensive overview for managing global manufacturing networks.
• These tools empower management to prioritize resources for continuous process improvement.
• Enhanced process understanding and risk mitigation are achieved through accurate data visualization.