Establishing and Applying Critical Quality Attributes ...

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 regulatory Specifications are chosen to confirm the Quality of the DS and DP rather than to establish full characterization, and should focus on those characteristics found to be useful in ensuring the safety and efficacy of the DS and DP.

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.”

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