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Process Control and Quality Assurance
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The concept of Quality by Design (QbD) is based on the evident fact that a high level of
quality of intermediate or final products cannot be achieved by testing the products
but needs to be implemented into the products by intelligently designing the whole
manufacturing process. To be able to do so, a comprehensive understanding of the
process on a causal basis is required. Only such an understanding ensures reliably
defined and consistent quality levels by operating stable and robust processes and, for
instance, in the case of pharmaceutical products, allows real-time release of the
manufactured goods. The technology that enables translation of the concept QbD
into industrial reality is process analytical technology (PAT). PAT is generally
considered a science-based and risk-based approach for the analysis and improved
control of production processes [1]. Although initially conceived by the FDA for
application in the pharmaceutical sector, the PAT initiative continues to grow in
importance also for related industries in the applied life sciences, for example,
biotechnology, the food industry, as well as the chemical industry
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Process Control and Quality Assurance
Management
English
Wiley-VCH Verlag GmbH & Co.
2012
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