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Considerations for a Decentralized Manufacturing Paradigm

ISPE

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. 3 (2020):e2970. 16 June 2020. New Project: Evolutive Vaccines Facility for Sanofi.” “Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” Organic Process Research and Development 24, no.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. July–August 2020). CPP 26 GMP Compression tooling (PQS) CPP 2 IPC Tablet hardness (P.3.4) CPP 5 Test DS identity (S.4.1)

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. July–August 2020). CPP 26 GMP Compression tooling (PQS) CPP 2 IPC Tablet hardness (P.3.4) CPP 5 Test DS identity (S.4.1)

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

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.