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Pharmaceutical Continuous Manufacturing: A Guide to Control Strategies for Solid Oral Dose Drugs

By Atul Dubey

USP

Published on CMKC

Abstract

Advanced manufacturing technologies like pharmaceutical continuous manufacturing (PCM) can provide potential efficiencies for many medicines and their ingredients, thereby facilitating geographic diversity in manufacturing and supply chain resilience. One of the ways the U.S. Pharmacopeia (USP) is working to assist manufacturers considering adoption of PCM is by addressing potential technical barriers through development of guidelines, best practices and strategies that can help ensure the quality of medicines made with PCM technology. The first in a planned series of USP technical guides for PCM covers development of control strategies for continuous manufacturing of solid oral dose drug products.

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