FDA Issues Guidance on Continuous Manufacturing

March 4, 2019

The FDA released draft guidance outlining its current thinking on innovative approaches to continuous manufacturing.

Because of the closed nature of continuous manufacturing systems — in which a feeder continuously adds input materials throughout the production run, with the option to introduce different batches of input materials at different points — the process is easier to control than batch manufacturing, the agency says.

The agency hopes the guidance will help resolve potential issues some companies have as they consider implementation, “such as concerns that use of new CM technology might impact the time FDA takes to assess applications for new products and switching from a batch to CM process for existing products,” according to Commissioner Scott Gottlieb and CDER Director Janet Woodcock.

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