Industry wide there is a drive for resource efficiency and flexibility, to adapt quickly in what is increasingly becoming a volatile, changing marketplace. As the ‘patent cliff’ looms for many high-volume API’s, there is also a shift away from blockbusters towards lower volume, higher potency API’s. This presents an opportunity to adopt newer methods of production that are more suited to the needs of flexible, lower volume, increased potency products, such as continuous manufacturing. Whilst an increasing number of continuous processes are being developed, one question continues to come up ‘how do regulators feel about continuous manufacturing?’. At a recent symposium, Dr Janet Woodcock Director of the Center for Drug Evaluation and Research Article (CDER) at the Food and Drug Administration (FDA) congratulated participants on the progress made over the past two years and confirmed that the ‘FDA will not be a barrier’ for continuous manufacturing. This and other events show an industry in transition, herein we provide an overview of the current regulatory perspective on continuous manufacturing.

• Chemtrix

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