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Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR

By Richard Steiner

Pharmatech Associates

Category

Website

Published on CMKC

Abstract

In pharmaceutical continuous manufacturing (PCM), technical solutions ensuring critical quality attributes for content uniformity and unit dose exist for online, in-line, and at-line measurements. Process analytical technology (PAT) allows in-line measurement and control of critical process parameters (CPP) that impact a product’s critical quality attributes (CQA).1 When applying quality by design (QbD) principles it is possible to define a process design space for a unit operation and integrate real-time process analytics into pharma and biopharma manufacturing processes. This creates the opportunity for real time release testing (RTRT) to replace conventional end-product testing, potentially saving a drug sponsor facility environmental control costs, inventory carrying costs, and testing costs for product release.

Journal

Pharmaceutical Online

Type of publication

Article

Affiliations

  • Phamatech Associates

Article Classification

Guest Column

Classification Areas

  • PAT

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