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AIChE PD2M Advanced Process Control workshop‐moving APC forward in the pharmaceutical industry

AIChE PD2M Advanced Process Control workshop‐moving APC forward in the pharmaceutical industry This whitepaper summarizes the outcome of the first Advanced Process Control (APC) workshop in the pharmaceutical industry, presented by AIChE PD2M, and held in Washington DC, Sep 30 to Oct 01, 2019. Approximately 50 attendees from regulatory agencies, industry and academia had an opportunity to share perspectives and best practices on the business, technical and regulatory aspects of APC for both small and large molecule drug manufacturing. The event consisted of keynote talks, case studies and panel discussions, filled with lively interactions that focused on: (a) Business drivers for APC in pharma; (b) Alignment on the definitions of key terminology; (c) Clarification of roles and relationships of APC with regards to popular initiatives such as Quality by Design (QbD), Process Analytical Technology (PAT), Real Time Release testing (RTRt), Continued Process Verification (CPV), continuous manufacturing and digital manufacturing; (d) APC manufacturing implementation considerations; (e) Quality system and regulatory considerations for APC implementation; (f) APC opportunities in modular manufacturing, process intensification, integrated continuous manufacturing. (g) standards, training, and collaboration. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Advanced Manufacturing and Processing Wiley

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Publisher
Wiley
Copyright
© 2021 American Institute of Chemical Engineers
eISSN
2637-403X
DOI
10.1002/amp2.10071
Publisher site
See Article on Publisher Site

Abstract

This whitepaper summarizes the outcome of the first Advanced Process Control (APC) workshop in the pharmaceutical industry, presented by AIChE PD2M, and held in Washington DC, Sep 30 to Oct 01, 2019. Approximately 50 attendees from regulatory agencies, industry and academia had an opportunity to share perspectives and best practices on the business, technical and regulatory aspects of APC for both small and large molecule drug manufacturing. The event consisted of keynote talks, case studies and panel discussions, filled with lively interactions that focused on: (a) Business drivers for APC in pharma; (b) Alignment on the definitions of key terminology; (c) Clarification of roles and relationships of APC with regards to popular initiatives such as Quality by Design (QbD), Process Analytical Technology (PAT), Real Time Release testing (RTRt), Continued Process Verification (CPV), continuous manufacturing and digital manufacturing; (d) APC manufacturing implementation considerations; (e) Quality system and regulatory considerations for APC implementation; (f) APC opportunities in modular manufacturing, process intensification, integrated continuous manufacturing. (g) standards, training, and collaboration.

Journal

Journal of Advanced Manufacturing and ProcessingWiley

Published: Jan 1, 2021

Keywords: ; ; ; ; ;

References