Critical Quality Attribute (CQA)

Definition

A Critical Quality Attribute is a physical, chemical, biological, or microbiological property or characteristic of a product that must fall within an appropriate limit or range to ensure the desired product quality. CQAs are the outcomes that Critical Process Parameters are controlled to protect.

Benefits

Defining CQAs clearly and linking them to in-process and finished product testing within the EBR gives manufacturers an early warning system, deviations affecting a CQA can be caught and investigated before a batch reaches final release testing.

Use Case

A pharmaceutical formulation team defines dissolution rate as a CQA for a tablet product. In-process testing data captured in the EBR is automatically checked against the CQA's acceptance range at each relevant step, rather than waiting until final QC testing to identify an issue.

Frequently Asked Questions (FAQ)

Related Terms

• Critical Process Parameter (CPP)
• Real-Time Release Testing (RTRT)