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Mar 1, 20231 min read

ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products

In today's FDA press release, the ICH final guidance titled "Q13 Continuous Manufacturing of Drug Substances and Drug Products" was...

Jul 28, 20211 min read

ICH Q13 Draft Guideline reaches Step 2 of the ICH process

ICH on 27 July 2021, confirmed that the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2...