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FDA Issues Draft Guidance on ICH Q13 Continuous Manufacturing

October 18, 2021

The FDA has released draft guidance on continuous manufacturing concepts for drug substances and drug products.

The 39-page guidance — prepared under the auspices of the International Council for Harmonization (ICH) — considers the development, implementation, operation and lifecycle management of continuous manufacturing.

Titled Q13 Continuous Manufacturing of Drug Substances and Drug Products, the draft document builds on existing ICH Quality guidelines, offering clarifications on continuous manufacturing concepts.

The new guideline looks at a system in which two or more unit operations are directly connected. In this context, any changes made in a unit operation of continuous manufacturing may have a direct and often immediate impact on downstream and upstream unit operations, the agency said.

Comments on the draft are due by Dec. 13.

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