5 key elements of quality by design in pharma

March 10, 2025

Remove from favorites

Add to favorites

The article "5 Key Elements Of Quality By Design In Pharma" discusses the importance of incorporating quality into every stage of the pharmaceutical manufacturing process, starting from research and development. This proactive approach, known as Quality by Design (QbD), is more effective than relying solely on post-production testing to eliminate substandard products.

The article highlights five practical elements of QbD in pharmaceuticals:

- Quality Target Product Profile (QTPP): Defining the desired quality characteristics of the final product.

- Critical Quality Attributes (CQAs): Identifying the attributes that must be controlled to ensure product quality.

- Risk Management: Implementing strategies to identify, assess, and mitigate risks throughout the development and manufacturing process.

- Design of Experiments (DoE): Using statistical methods to understand the relationships between factors affecting a process and the output of that process.

- Control Strategy: Developing a comprehensive plan to monitor and control the manufacturing process to ensure consistent product quality.

The article also emphasizes the role of a Quality Management System (QMS) in supporting QbD by providing a structured framework for implementing these elements.