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Considerations for a Decentralized Manufacturing Paradigm

ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. September 2004. Distributed Manufacturing and Point-of-Care Manufacturing of Drugs.” “Developing the Biofacility of the Future Based on Continuous Processing and Single-Use Technology.” September 2004. 2 (1 May 2005).

Health and Personal Care Stores 52
Health and Personal Care Stores Vaccines Packaging Documentation 52
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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

AUGUST 30, 2022

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.

Documentation 52
Documentation FDA Packaging Communication 52
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