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ICH Q13: Continuous Manufacturing Guidance

‐ Jul 14, 2021 2:05pm

ICH Q13, Continuous Manufacturing of Drug Substances and Drug Products, is progressing through document development with endorsement of Stage 1 expected in May 2021. This document is expected to provide guidance to industry and regulatory agencies regarding regulatory expectations on the development, implementation, and assessment of CM technologies used in the manufacture of drug substances and drug products. This session will feature perspectives from regulators, industry and the ICH Q13 Expert Working Group (EWG) on the motivation for ICH Q13, the perceived benefits, progress, and challenges to-date. Participants will have an opportunity through the panel discussion to share their hopes and concerns with those directly involved with the development of the document.

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