White Papers / Tech Papers
Pharmaceutical Continuous Manufacturing: USP Technical Guide
The first in a planned series of guides, launched in August 2023, covers control strategies for continuous manufacturing of solid oral dose drugs.
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.
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The technical guide is a practical resource for industry stakeholders developing PCM processes but does not constitute official USP standards.
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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.
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For a high-level overview of the guide, see the related Quality Matters blog here.
To download the guide, please click here >>>>>
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