A Perspective on Quality-by-Control (QbC) in Pharmaceutical Continuous Manufacturing

Overview

Journal Comput Chem Eng

Date 2023 Feb 27

PMID 36845965

Authors

Qinglin Su

Sudarshan Ganesh

Mariana Moreno

Yasasvi Bommireddy

Marcial Gonzalez

Gintaras V Reklaitis

Zoltan K Nagy

Affiliations

Soon will be listed here.

Abstract

The Quality-by-Design (QbD) guidance issued by the US Food and Drug Administration (FDA) has catalyzed the modernization of pharmaceutical manufacturing practices including the adoption of continuous manufacturing. Active process control was highlighted recently as a means to improve the QbD implementation. This advance has since been evolving into the concept of Quality-by-Control (QbC). In this study, the concept of QbC is discussed, including a definition of QbC, a review of the recent developments towards the QbC, and a perspective on the challenges of QbC implementation in continuous manufacturing. The QbC concept is demonstrated using a rotary tablet press, integrated into a pilot scale continuous direct compaction process. The results conclusively showed that active process control, based on product and process knowledge and advanced model-based techniques, including data reconciliation, model predictive control (MPC), and risk analysis, is indispensable to comprehensive QbC implementation, and ensures robustness and efficiency.

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