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Contamination Trends & Proposed Solutions

ISPE

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.”