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Considerations for a Decentralized Manufacturing Paradigm

ISPE

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. POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers: Program Announcement.” Burke, PhD. 1 September 2022. 5 (May 2022): 1232–1244.