FDA Seeks Feedback On Continuous Manufacturing

US Agency Opens Up ICH Q13 Draft Guidance For Comment

A draft ICH guidance on continuous manufacturing has been opened up for comment by the FDA, as continuous manufacturing becomes an increasingly prominent topic for the generics industry.

Continuous Production Manufacturing Gears
The FDA is asking for views on continuous manufacturing • Source: Shutterstock

Interested stakeholders have until 13 December 2021 to submit comments on draft International Council for Harmonisation guidance that the US Food and Drug Administration has published for feedback.

The FDA summarized that the Q13 Continuous Manufacturing of Drug Substances and Drug Products

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