What are Critical Quality Attributes (CQAs) and how are they determined?

CQAs are physical, chemical, biological, or microbiological properties that must be within appropriate limits to ensure product quality. Determination involves: identifying all quality attributes through characterization, assessing impact on safety and efficacy (using risk tools like FMEA), classifying attributes based on risk, and linking CQAs to process parameters. For biologics, CQAs typically include: glycosylation pattern, charge variants, aggregates, potency, host cell proteins, and residual DNA. CQAs are established during development, verified during clinical trials, and specified in regulatory filings. Control strategies ensure CQAs are consistently met through process parameter control, in-process testing, and release testing.