Considerations for a Decentralized Manufacturing Paradigm
ISPE
SEPTEMBER 11, 2023
Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. 3 , 27 Advantages POD increases manufacturing flexibility, speed, and consistency. EMA/CHMP/BWP/187162/2018. 22 March 2018. www.ema.europa.eu/en/documents/report/meeting-report-joint-biologics-working-party/quality-working-party-workshop-stakeholders-relation-prior-knowledge-its-use-regulatory
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