Skip to main content

Critical Quality Attribute

Meaning

A Critical Quality Attribute (CQA) is a defined physical, chemical, biological, or microbiological characteristic that must consistently remain within an approved limit, range, or distribution to reliably ensure the desired quality, safety, and efficacy of a drug product. Within the pharmaceutical and compounding industry, particularly for customized hormonal preparations, CQAs are the essential parameters directly correlated with the final drug product’s performance and patient outcome. Examples of CQAs include the precise concentration of the active pharmaceutical ingredient, the purity profile free of contaminants, and the absolute sterility of the final dosage form. Rigorous control over these attributes is a non-negotiable cornerstone of regulatory compliance and fundamental patient safety.