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CMC And GMP Updates In Brief: Continuous Manufacturing, Accelerated CMC Reviews

 
• By Bowman Cox

ICH  general assembly adopts guidelines on continuous manufacturing and risk management; US FDA opens pilot project to expedite CMC reviews for products with accelerated review timelines; other recent topics include quality maturity inspections and compounding standards.

The general assembly of the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use on 16 November adopted the ICH Q13 guide on continuous manufacturing at its meeting in Incheon, South Korea, sources said.

In coming months, ICH member authorities will publish final harmonized Q13 guidance

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