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Harnessing continuous improvement in the CAPA process

European Pharmaceutical Review

AUGUST 3, 2023

The optimised framework aims to overall, drive higher product quality and improved patient safety. Summarising recommendations and best practices for CAPA process improvement, this whitepaper uses data collected from a pilot suggested in the MDIC’s initial whitepaper that proposed the framework.

Documentation 52
Documentation Process Improvement FDA 52
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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.

Health and Personal Care Stores 52
Health and Personal Care Stores Vaccines Packaging Documentation 52
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