Abstract The Quality-by-Design (QbD) guidance issued by the US Food and Drug
Administration (FDA) has catalyzed the modernization of pharmaceutical manufacturing …

Pharmaceutical continuous manufacturing is considered as an emerging technology by the
regulatory agencies, which have defined a framework guided by an effective quality risk …

It is desirable for a pharmaceutical final dosage form to be manufactured through a quality
by design (QbD)-based approach rather than a quality by testing (QbT) approach. An …

The next generation of QbD based pharmaceutical products will be manufactured through
continuous processing. This will allow the integration of online/inline monitoring tools …

A novel manufacturing strategy based on continuous processing integrated with
online/inline monitoring tools coupled with an advanced control system is highly desired for …

This white paper provides a perspective of the challenges, research needs, and future
directions for control systems engineering in continuous pharmaceutical processing. The …

Recently, the pharmaceutical industry has been facing several challenges associated to the
use of outdated development and manufacturing technologies. The return on investment on …

Abstract The Food and Drug Administration (FDA) regulates pharmaceutical drug products
to ensure a continuous supply of high-quality drugs in the USA. Continuous processing has …

The pharmaceutical industry faces multiple challenges (eg, inefficient manufacturing
techniques, quality control issues, and supply chain vulnerabilities) because of its current …

A novel manufacturing strategy based on continuous processing integrated with online
monitoring tools coupled with efficient automatic feedback control system is highly desired …