Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing

The FDA and Product Quality Research Institute (PQRI) will host a webcast workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing on 14-16 November 2022.

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 aims to facilitate 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.

Please visit PQRI’s Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing website for more information.