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Manufacture Business Practice, Drug Delivery, Formulation, Quality & Compliance, Trends & Forecasts

Extending the boundaries of QbD

sponsored by Malvern Panalytical

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.

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