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Continuous Manufacturing Guidance From US FDA Aims For Wider Industry Adoption

 
• By Shannon Brown

Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’

Guidance published for international harmonization of continuous manufacturing process • Source: Alamy

Six years after the first approval of a drug made using continuous manufacturing, the US Food and Drug Administration published a draft guidance to help drugmakers implement the process more widely.

The agency’s draft is identical to the International Council on Harmonization Q13 guidelines, but the guidance has been “reformatted and edited to conform with FDA’s good guidance

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