Holistic QbD: A Key To Improved Profitability And Sustained Competitive Advantage With Sterile Pharmaceutical Products

By Fran DeGrazio, Vice President, Global Research and Development, Pharmaceutical Packaging Systems West Pharmaceutical Services, Inc.

Pharmaceutical companies are faced with assuring that new quality and compliance paradigms can be met while facilitating profitability to continue adequate business reinvestment. Understanding and managing direct and indirect costs associated with all phases of a drug product lifecycle can be challenging due to complex supply chains and increasing demands to ensure patient safety. Indirect costs can be hidden, making them more difficult to measure and quantify, and often are not factored into the total cost of ownership. Strategies to help support the goals for saving money, maintaining compliance, and accelerating development and manufacture of drug products are encompassed in Quality by Design (QbD) concepts. A process designed with QbD principles requires a significant up-front investment. However, QbD delivers an improved, data-driven output, providing manufacturers with superior product and process understanding that minimizes process risk, emphasizes patient-critical quality requirements and enhances drug product effectiveness. A more efficient process results in a much higher quality final deliverable with well-understood and controlled sources of variation.