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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Finally, the DP is packaged in a suitable container to ensure continued quality.

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Rapid Filter or Resin Change Strategies for Biomanufacturing

ISPE

The initial PAS would also include a commitment to provide any at-scale product quality and/or validation data in the US Annual Report of Minor Changes (ARMC) or potentially a submission at the time of distribution (changes being effected [CBE-0]).