> ## 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.

# PhRMA Suggests Continuous Manufacturing Guidance Changes
- URL: https://www.fdaweb.com/phrma-suggests-continuous-manufacturing-guidance-changes/
- Published: 2019-08-14T12:00:00.000Z
- Updated: 2026-09-15T01:43:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144763

Pharmaceutical Research and Manufacturers of America (PhRMA) says it generally supports an FDA draft guidance on quality considerations for continuous manufacturing and believes the document could benefit from greater clarity on some key concepts. The association’s comment [letter](https://www.regulations.gov/document?D=FDA-2019-D-0298-0026&ref=fdaweb.com) also says the guidance’s language could be enhanced to better facilitate adoption of continuous manufacturing in the biopharmaceutical industry.

The letter includes general comments, including the scope, hybrid systems, expectations for utilization of advanced elements, and international harmonization, and comments on defining batches and scale for continuous manufacturing processes, regulatory filing expectations, process validation and process verification, and FDA-requested feedback. PhRMA also includes a chart of detailed line-by-line comments and recommended changes.