Industry stakeholders have proposed ways to adapt the facility-specific regulation of drug manufacturing quality for emerging distributed and point-of-care manufacturing technologies that would reduce compliance burden but also in some cases could reduce quality assurance.
How Industry Would Reduce The Regulatory Burden For Fleets Of Mobile Manufacturing Units
Stakeholders propose centralized oversight approaches for managing quality of “like-for-like” fleets of self-contained manufacturing units that could roam the US – or the world. The US FDA shares the industry’s thinking on how best to adapt the site-focused regulatory scheme it enforces to the emerging variety of distributed manufacturing systems.
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