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 . -ICH Q8 (R2) (Pharmaceutical Development) Product Quality is defined in terms of Specifications and Critical Quality Standards and Attributes Definition: Parameter/test Assay Criterion Sterility 14 day culture, aerobic and anaerobic No growth Specification: 4 Definition: specifications Full product characterization Specifications are Critical Quality standards (CQAs) that are proposed and justified by the manufacturer and approved by reg

5 Research Preclinical Phase I Phase II Phase III BLA Clinical efficacy Potency Preclinical efficacy But efficacy data is not usually obtained until late in …

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