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.