In football, part of the coaches’ jobs are to analyze an upcoming opponent, identify both their strengths and weaknesses, and then develop plays that are tailored to a game plan designed for victory. When the quarterback calls the play in the huddle, everyone settles into the pre-planned formation and the goal is forward progress, preferably into the end zone. If something goes wrong, the tapes are reviewed in order to learn from the mistake. Football, like any team sport, uses a carefully planned and executed strategy to eliminate failure, and ultimately win the game.
In business, especially one that deals with human lives, it only makes sense that this same calculated risk-based and iterative approach to reducing error should be applied. Many would argue that the most effective way to do this in pharma would be by using a Quality by Design (QbD) methodology. However, just like in the example of football, in order to do it successfully, it takes an entire team of dedicated experts with the right mind set working toward the same goal.
|Rosario LoBrutto, Senior Director, Head of Development Parenterals at Teva|
Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. “Quality by design is part of the development strategy to get the best possible method or analysis technique and to implement the right risk analysis at the right time to understand the critical sources of variability and how to proactively control it,” explains LoBrutto.
In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics:
These three phases are the necessary prerequisites to build the backbone for the risk mitigation process. The key is to organize the data systematically and visualize the entire complex processes, in order to better facilitate decision making. Like football, LoBrutto says the first step in applying QbD to analytics is identifying the possible areas of weakness, or the risks.