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GUIDANCE DOCUMENT

Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry March 2023

Download the Final Guidance Document
Final Level 1 Guidance
Docket Number:
FDA-2021-D-1047
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-1047.

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