A perspective on Quality-by-Control (QbC) in pharmaceutical continuous manufacturing
Abstract The Quality-by-Design (QbD) guidance issued by the US Food and Drug
Administration (FDA) has catalyzed the modernization of pharmaceutical manufacturing …
Administration (FDA) has catalyzed the modernization of pharmaceutical manufacturing …
Model predictive control in pharmaceutical continuous manufacturing: A review from a user's perspective
M Jelsch, Y Roggo, P Kleinebudde… - European Journal of …, 2021 - Elsevier
Pharmaceutical continuous manufacturing is considered as an emerging technology by the
regulatory agencies, which have defined a framework guided by an effective quality risk …
regulatory agencies, which have defined a framework guided by an effective quality risk …
Implementation of an advanced hybrid MPC–PID control system using PAT tools into a direct compaction continuous pharmaceutical tablet manufacturing pilot plant
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 …
by design (QbD)-based approach rather than a quality by testing (QbT) approach. An …
System-wide hybrid MPC–PID control of a continuous pharmaceutical tablet manufacturing process via direct compaction
The next generation of QbD based pharmaceutical products will be manufactured through
continuous processing. This will allow the integration of online/inline monitoring tools …
continuous processing. This will allow the integration of online/inline monitoring tools …
A systematic framework for onsite design and implementation of a control system in a continuous tablet manufacturing process
A novel manufacturing strategy based on continuous processing integrated with
online/inline monitoring tools coupled with an advanced control system is highly desired for …
online/inline monitoring tools coupled with an advanced control system is highly desired for …
A review on the modernization of pharmaceutical development and manufacturing–Trends, perspectives, and the role of mathematical modeling
Recently, the pharmaceutical industry has been facing several challenges associated to the
use of outdated development and manufacturing technologies. The return on investment on …
use of outdated development and manufacturing technologies. The return on investment on …
Control systems engineering in continuous pharmaceutical manufacturing May 20–21, 2014 continuous manufacturing symposium
AS Myerson, M Krumme, M Nasr, H Thomas… - Journal of …, 2015 - Elsevier
This white paper provides a perspective of the challenges, research needs, and future
directions for control systems engineering in continuous pharmaceutical processing. The …
directions for control systems engineering in continuous pharmaceutical processing. The …
Modernizing pharmaceutical manufacturing: from batch to continuous production
SL Lee, TF O'Connor, X Yang, CN Cruz… - Journal of …, 2015 - Springer
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 …
to ensure a continuous supply of high-quality drugs in the USA. Continuous processing has …
Design and commercialization of an end-to-end continuous pharmaceutical production process: a pilot plant case study
CJ Testa, C Hu, K Shvedova, W Wu… - … Process Research & …, 2020 - ACS Publications
The pharmaceutical industry faces multiple challenges (eg, inefficient manufacturing
techniques, quality control issues, and supply chain vulnerabilities) because of its current …
techniques, quality control issues, and supply chain vulnerabilities) because of its current …
An engineering study on the enhanced control and operation of continuous manufacturing of pharmaceutical tablets via roller compaction
A novel manufacturing strategy based on continuous processing integrated with online
monitoring tools coupled with efficient automatic feedback control system is highly desired …
monitoring tools coupled with efficient automatic feedback control system is highly desired …