Why Modern Pharmaceutical Development Requires System Level Thinking?
Challenges in Modern Pharmaceutical Development:
The development of a drug product involves multiple interrelated factors that influence quality, safety, efficacy, and manufacturability.
A change in one component (e.g., raw material, formulation composition, process parameter, etc.) can affect the critical quality attribute of the drug product.
Therefore, the pharmaceutical development must consider the entire system and the interaction between the components.
What is System-Level Thinking?
Barry Richmond, a well-known leader in the field of systems thinking and systems dynamics, is credited with coining the term “systems thinking” in 1987. In short, interdependency demands Systems Thinking.
The term has been defined and redefined in many different ways since its coining by Barry Richmond in 1987. According to the Merriam-Webster dictionary, a system is defined as a regularly interacting or interdependent group of items forming a unified whole. A basic principle of a system is that it is something more than a collection of its parts.
Key Elements:
Material, Process & Product Performance
Successful pharmaceutical development requires thorough understanding of:
- Critical Material Attributes
- Critical Process Parameter
- Critical Quality Attributes
Recognizing the relationship among these elements enables the developers to build the quality, manage the variability and ensure product performance.
Role of QBD:
Quality by Design symbolizes the system level thinking as the science and risk-based strategy are made throughout the development, rather than relying solely on the end-product testing.
It is important to recognize that quality cannot be tested into products, i.e., quality should be built in by design. Changes in formulation and manufacturing processes during development and lifecycle management should be looked upon as opportunities to gain additional knowledge and further support establishment of the design space.
Conclusion:
As the Modern Pharmaceutical Development continues to evolve System-Level thinking is no longer an option- it is essential.
Ultimately the success depends on looking beyond individual components and understanding how they work together as a whole.