Critical Quality Attributes (CQA)

Key quality factors

Critical Quality Attributes (CQA) is defined in ICH Q8, Pharmaceutical Development, as "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". To determine if a product meets the appropriate CQA assay tests are performed which directly meassure the product's quality. Published monographs, found within the USP, set forth the required testing and acceptance criteria used to ensure a specific product meets standards.