All Categories (1-2 of 2)

1. Implementation of ICH Q13 Continuous Manufacturing Guidance

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   | Contributor(s):: Rapti Madurawe

   Continuous Manufacturing (CM) BasicsICH Q13 GuidanceFDA ExperienceFuture Directions and Enabling CM of GenericsPharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing - 10/31/2023 | FDA

2. Global Regulatory Landscape

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   | Contributor(s):: Matsuda, Y

   Continuous manufacturing (CM) of pharmaceuticals is a rapidly growing approach in the production of active pharmaceutical ingredients and finished products. The European Medicines Agency, the US Food and Drug Administration, and the Pharmaceuticals and Medical Devices Agency have independently...