> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Posts Guide on Drug Continuous Manufacturing
- URL: https://www.fdaweb.com/fda-posts-guide-on-drug-continuous-manufacturing/
- Published: 2021-10-13T12:00:00.000Z
- Updated: 2026-09-14T17:18:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150363

FDA has posted a [draft guidance](https://www.fda.gov/media/153044/download?ref=fdaweb.com) entitled *Continuous Manufacturing of Drug Substances and Drug Products — Q13*. The document describes scientific and regulatory considerations for developing and implementing continuous manufacturing (CM). It also provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products.

Continuous manufacturing involves the “continuous feeding of input materials into, the transformation of in-process materials within, and the concomitant removal of output materials from a manufacturing process,” the guidance says. “While this description may apply to an individual unit operation (e.g., tableting, perfusion bioreactors), this guideline focuses on the integrated aspects of a CM system in which two or more unit operations are directly connected. In this context, any changes made in a unit operation of CM may have a direct and often immediate impact on downstream and upstream (e.g., via a feedback control) unit operations.”

The guidance also includes annexes that provide illustrative examples and considerations specific to certain modalities (e.g., chemical entities, therapeutic proteins), technologies, and production methods (e.g., integration of drug substance and drug product manufacturing).