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Harnessing continuous improvement in the CAPA process

European Pharmaceutical Review

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.

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Quality Essentials Review: Advancing Medication Therapy Management Quality Measurement

PQA

Cooke, Research Associate Professor at the University of Maryland School of Pharmacy, Aaron Larson, VP of Health Plan Quality Analytics at UnitedHealth Group and Anita Pothen Skaria, Vice President of Quality and Process Improvement with Centene Corporation. Develop new performance measures for MTM quality.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

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.