Q13 Continuous Manufacturing of Drug Substances and Drug Products

This guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing International Council for Harmonization (ICH) Quality guidances, this guidance provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products.

NEWS - BIO CHEM S.R.L.

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Q13 continuous manufacturing of drug substances and drug products
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