Abstract
AbstractThis 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.
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