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Terminology Definitions for Pharma, Biopharma, and Medical Device Industries

Critical Quality Attribute

What is a Critical Quality Attribute?

Abbreviation: CQA

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Critical quality attributes are the physical, chemical, biological, or microbiological properties or characteristics of a product that must be controlled within defined limits to ensure safety, efficacy, and quality. CQAs are identified during development and closely monitored throughout production to ensure that the final product consistently meets its required standards. The control of critical process parameters (CPPs) is essential to maintaining CQAs, as CPPs are the key variables in the production process that directly impact these attributes. Examples of CQAs might include the potency, purity, or stability of a drug product.

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