One way that USP assists manufacturers who are considering adoption of pharmaceutical continuous manufacturing (PCM) is with technical guides* that can help them ensure quality. The first in a planned series of guides, launched in August 2023, covers control strategies for continuous manufacturing of solid oral dose drugs.
- The technical guide is a practical resource for industry stakeholders developing PCM processes but does not constitute official USP standards.
- While regulatory guidance on PCM is available from ICH and FDA, the technical guide provides more detailed, practical illustrations of key concepts that can help ensure quality.
- For a high-level overview of the guide, see the related Quality Matters blog here.
- To download the guide, please complete and submit the form.
To provide feedback on the technical guide or input for future guides, email PCM@usp.org
*Related legal disclosures and terms of use are located within the guide.
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Blog: A Guide to Control Strategies for Solid Oral Dose Drugs
USP’s technical guide represents a practical resource for industry stakeholders developing PCM processes. Topics covered include material characterization, risk assessment, experimental design, process analytical technology development and tools, and scale-up considerations.