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# ICH Drug Continuous Mfg. Guidance Open for Comment
- URL: https://www.fdaweb.com/ich-drug-continuous-mfg-guidance-open-for-comment/
- Published: 2021-07-28T12:00:00.000Z
- Updated: 2026-09-14T17:08:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149802

The International Council for Harmonization (ICH) Q13 guidance on continuous manufacturing of drug substances and drug products completed step 2 of the ICH process 7/27 and is now available for public review and comment. An ICH online [post](https://ich.org/news/ich-q13-draft-guideline-reaches-step-2-ich-process?ref=fdaweb.com) (contains a link to the guidance) says the document describes scientific and regulatory considerations for developing, implementing, operating, and managing the lifecycle of continuous manufacturing (CM).

“Building on existing ICH quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products,” the post says.

ICH says the guidance applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It applies to CM for new products and the conversion of batch manufacturing to CM for existing products. It says the guidance principles may also apply to other biological/biotechnological entities.