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Expanding the Boundaries of QbD

The last decade has seen a shift within the pharmaceutical industry towards a design space approach to development and manufacture, an agenda underpinned by ICHQ8, Q9 and Q10 and the concept of Quality by Design (QbD). However, because a design space approach naturally focuses attention on the areas of a project that are potentially the most vulnerable to failure it has broader value for risk management.

Within the pharmaceutical industry, those most confident and comfortable with QbD are beginning to extend its application beyond the product development path to, for example, the deployment of analytical equipment and associated method development, validation and transfer. The roots of the integrity of analytical data lie in the approach taken to the design and manufacture of the analytical instrument. Analytical instrument companies that align themselves with a QbD philosophy can therefore offer pharmaceutical customers the reassurance of closely similar working practices and products that meet the exacting standards of the industry.

In this article Paul Davies and Paul Kippax from Malvern Instruments examine how a QbD approach can inform analytical instrumentation design and manufacture, focusing on the benefits for those who go on to use the equipment. Examples from the development of the Mastersizer 3000 particle size analyzer demonstrate the practicalities.