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Considerations for a Decentralized Manufacturing Paradigm

ISPE

SEPTEMBER 11, 2023

Then substantial time and resources are needed to run the same manufacturing process at the receiving site and test the resulting product in quality control (QC) laboratories or use emerging technologies, such as PAT or RTRT, to generate release and characterization data demonstrating analytical comparability. EMA/CHMP/BWP/187162/2018.

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Health and Personal Care Stores Vaccines Packaging Documentation 52
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