Contract manufacturing


Can quality be outsourced?


Medical device OEMs are increasingly taking advantage of the services offered by specialist consultancies that provide end-to-end support for quality by design (QbD) services, choosing to outsource rather than develop these capabilities in-house. Jim Banks looks at how software vendors are incorporating QbD into their quality management system offerings and how this helps OEMs to optimise complex manufacturing processes.


T


he quality by design (QbD) methodology is nothing new for the medical device or life sciences industries, but it has evolved over time. Since the mid-20th century, and in works such as Joseph M Juran’s Quality Planning and


Analysis, quality planning has been a core tenet of QbD. The approach has become fundamental to the way medical device companies employ risk-based strategies to make product development quicker, better and more efficient. QbD is simple in essence. It is a systematic approach to ensuring product quality by building it into the design and development process rather than waiting until the end-product testing stage to evaluate quality. It represents a shift towards a proactive method based on scientific principles, risk assessment and statistical methodologies to create high-quality devices rather than traditional reactive quality control processes. It starts with clearly defined objectives, including the device’s intended use, its desired performance characteristics and


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