Integrating Quality by Design (QbD) in Medical Device Manufacturing - Concept, Benefits and Challenges
16 November 2011This white paper discusses the Quality by Design (QbD) concept and its integration into the medical devices industry, along with its uses and challenges expressed by manufacturers.
It states that many of the larger pharmaceutical companies have introduced the QbD concept to improve their manufacturing processes early on in the design phase.
The QbD concept, along with Process Analytical Technology (PAT), will help initiate a new system that will provide quality and understanding of the manufacturing process by industry.
The paper explains that as the QbD concept introduces quality at the design level, understanding common cause variability and variation of the process and product is crucial.
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Integrating Quality by Design (QbD) in Medical Device Manufacturing - Concept, Benefits and Challenges
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