Regulators Encourage Transition from Batch to Continuous Processing
This article was originally published in The Gold Sheet
As pharmaceutical manufacturers increasingly look to continuous processing technologies as a way of controlling costs and potentially increasing drug quality, regulators in the U.S. and the European Union are beginning to use more flexible, quality-by-design-like approaches in evaluating these systems.
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FDA's process validation guidance puts a new emphasis on statistical controls. Like it or not, the guidance offers new flexibility. Also, it expands the focus of process validation from commercial scale-up to a lifecycle approach that includes process design studies as well as continuous verification during commercial manufacturing activities.