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Establishing and Applying Critical Quality …
1 ISCT Liaison Meeting October 19, 2016 Tom Finn, Product Reviewer Office of Tissues and Advanced Therapies FDA/CBER Establishing and Applying Critical Quality Attributes During the Product development Lifecycle 2 Topics Product terminology CQA and CPP and how they are developed and used during the product lifecycle Considerations for demonstrating product comparability after a manufacturing change 3 A CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product Quality .
• Early product development and preclinical data are used to justify safety and quality of the product for use in clinical studies • FDA encourages continual improvements to product quality, but that must be balanced with
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