A committee under the auspices of the National Academies of Sciences, Engineering, and Medicine (NASEM) is conducting a study with the aim of producing a consensus report that identifies emerging and upcoming technologies that have the potential to advance pharmaceutical quality and modernize pharmaceutical manufacturing for products regulated by the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER).
At the request of NASEM and following workshops at which ISPE Members presented, ISPE was invited to provide input. The below is ISPE’s response, issued on 17 August 2020.
“ISPE appreciates the opportunity to provide input into the National Academics of Science, Engineering and Medicine related to Identifying Innovative Technologies to Advance Pharmaceutical Manufacturing. ISPE is a leading not for profit organization of more than 18,000 individual members reflective of technical, engineering, quality, and operational activities throughout pharmaceutical product lifecycle. A major part of ISPE’s efforts to connect pharmaceutical knowledge focuses on advancing scientific and regulatory concepts for innovation in pharmaceutical products, manufacturing processes and facilities through community discussions, conferences and training, and publications of articles and guidance documents.
“ISPE is actively developing several of the topics discussed in the June 2-3, 2020 NASEM Virtual Workshop including continuous manufacturing (both small and large molecule), portable and modular manufacturing, patient centric quality standards, and process analytical technologies. While each of these topics were covered to some extent in the workshop, additional emphasis should be given on the need to harmonize the approaches with regulators globally. ISPE welcomes a discussion to advance international regulatory harmonization including the deployment of new and innovative manufacturing technologies.
“Digitization and automation are rapidly evolving topics that were not covered in the June NASEM Workshop. ISPE’s Pharma 4.0™ initiative is a movement to align pharmaceutical manufacturing with best in class practices from other sectors including aspects such as robotics, artificial intelligence, and distributed cloud service-based architecture. Implementation of these approaches will pave the way for more complex control strategies including automated manufacturing with integrated process measurements and control. Similar concerns exist for these technologies and the need for international regulatory harmonization.
“ISPE views this topic as very relevant for the industry as increased pressure is placed on assurance of availability of quality medicines. If mutually agreeable, further dialog on the topic can be arranged.”
Further information on the NASEM study.
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