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# Comments on ICH Q13 Continuous Manufacturing Guidance
- URL: https://www.fdaweb.com/comments-on-ich-q13-continuous-manufacturing-guidance/
- Published: 2021-12-15T12:00:00.000Z
- Updated: 2026-09-14T17:25:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150779

Commenting on an International Council for Harmonization (ICH) draft guidance, *Q13 Continuous Manufacturing of Drug Substances and Drug Products*, the United States Pharmacopeia [asks](https://downloads.regulations.gov/FDA-2021-D-1047-0010/attachment%5F1.pdf?ref=fdaweb.com) how the ICH guidance, when finalized, will affect an FDA draft guidance on quality considerations for continuous manufacturing.

In its comment [letter](https://downloads.regulations.gov/FDA-2021-D-1047-0009/attachment%5F1.pdf?ref=fdaweb.com), Lilly says it has reviewed the ICH guidance and is making recommendations for changes “we believe will enhance the usability and clarity of this guidance.” It gives line-by-line recommendations for proposed edits.

The Biotechnology Innovation Organization also submits a [chart](https://downloads.regulations.gov/FDA-2021-D-1047-0011/attachment%5F1.pdf?ref=fdaweb.com) with specific detailed comments.