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The Building Blocks of Quality by Design (QbD) Implementation

    The Building Blocks of Quality by Design (QbD) Implementation

    This post is part of a monthly series of short commentaries from the Institute of Validation Technologies (IVT) on the use of Quality by Design (QbD) in the pharma and biotech industries. The use of QbD has steadily grown since its introduction around 2005. The growth has not been fast enough for some and perhaps too fast for others. Some of the resistance is due to lack of understanding what QbD is. This is not uncommon for a new idea. QbD is new to pharma and biotech but not new to other industries. This is good news as pharma and biotech can learn from the experience of others. The breadth of application and understanding of QbD has grown since it was first introduced mainly in the chemical industry in the 1950s and 1960s. I learned about QbD in my graduate work at Rutgers University and practiced and enhanced the art and science, first during by 24 year tenure at DuPont and today as a keen focus of my consulting practice and research programs.

    It is important to begin these commentaries by answering the question ‘What is QbD’; and then discuss the building blocks of QbD. The ICH Q8 (R2) definition is that QbD is a “Systematic approach to product and process development that begins with predefined objectives, emphasizes product and process understanding and  process control and is based on sound science and quality risk management (1).” In other words, Quality by Design is about building quality into products and processes, not attempting to inspect quality in at the end on the line.  Continue Reading Post

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