FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement
A Virtual Event: Monday – Wednesday, November 14 – 16, 2022
PQRI and FDA hosted an FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing on November 14 – 16, 2022, as a virtual event.
The FDA/PQRI Workshop brought together leaders from regulatory agencies, industry, and academia to discuss critical topics in distributed manufacturing and point of care manufacturing.
Future pharmaceutical manufacturing may occur not only in large manufacturing facilities; it may occur in smaller, more geographically distributed facilities or even at the point of care. The National Academies of Sciences, Engineering, and Medicine noted in a 2021 report that FDA is likely to see substantial innovations in integrated, flexible, and distributed manufacturing (DM). These innovations include modular approaches to streamline drug and biologic production and the deployment and use of highly portable manufacturing units that could enable point of care (POC) manufacturing. These types of technologies may challenge the traditional approaches to regulating pharmaceutical manufacturing.
FDA has also encountered the rapid emergence of advanced manufacturing technologies in various investigational biological products, such as tissue-based, cell and gene advanced therapy products, intersecting with critical areas associated with DM and POC manufacturing. Such biologics are generally more complex with undefined critical quality attributes and often have different manufacturing paradigms. This is particularly true for cellular and gene therapy products and tissue-engineered products.
The Workshop facilitated interaction among DM/POC stakeholders on critical areas for development and implementation of these technologies including terminology, technical challenges to adoption, operation of Pharmaceutical Quality Systems, good manufacturing practice expectations, and the unique challenges and considerations that apply to complex biologics.
FDA Seeks Public Feedback
FDA is seeking feedback on the Distributed Manufacturing and Point-of-Care Manufacturing of Drugs Discussion Paper. Comments are due by December 13, 2022. The FDA encourages stakeholders to provide comments under docket number FDA-2022-N-2316.
Workshop Oveview
Day 1: Session 1 – Harmonizing Terminology Among All Stakeholders and Session 2 – Operating/Business Models between DM/POC Applicants and DM/POC Sites – click here to view abstracts, presentations, and bios.
Day 2: Session 3 – DM/POC Location and Sizes of Spaces at Sites and Session 4– Structure of DM/POC Pharmaceutical Quality Systems and Assuring Quality Oversight – click here to view abstracts, presentations, and bios.
Day 3: Session 5 – Strategies to Ensure that Drugs and Biologics Meet Established Specifications and Session 6: DM/POC Suitability for CBER Regulated Products – click here to view abstracts, presentations, and bios.
Workshop Materials
The Final Program is available here.
Thank you to our Sponsors! |
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QUESTIONS
Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5607 or PQRISecretariat@pqri.org.