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Embracing QbD And PAT

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Embracing QbD And PAT

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Article: Embracing QbD And PAT

By Tim Freeman, Director of Operations, Freeman Technology

In recent decades the pharmaceutical industry has used innovative, cutting edge technology to research and develop new drugs of immense value to society. By comparison there has been relatively little emphasis on processing, so these products tend to be manufactured using empirically developed, relatively inefficient, batch processes. The advent of Quality by Design (QbD) and the Process Analytical Technology (PAT) initiative invites the industry to use its considerable skills to address this imbalance, and transform process operation and efficiency. One of the keys to this transformation will be a better understanding of powders since almost all pharmaceutical products are handled in this form at some point during manufacture. Modern powder characterization methods have an important role to play providing data that can used to convert process- or product-specific experience into more fundamental knowledge.

About the author:
Tim Freeman has a degree in Mechatronics from the University of Sussex in the UK and has worked for Freeman Technology since the mid 1990s. Since Freeman's launch of the FT4 Powder Rheometer he has been responsible for application and method development and works closely with customers in the pharmaceutical and powder processing industries. Tim is currently Director of Operations for Freeman Technology.

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Article: Embracing QbD And PAT

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