ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Critical Quality Attribute (CQA)

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. CQAs are generally associated with the drug substance, excipients, intermediates (in process materials) and drug product. (ICH Q8 (R2) II 2.2)

Publication Source: ISPE Good Practice Guide: Process Gases

Publication Date: 2011

Critical Quality Attribute (CQA)

(ICH Q8 (R2)) 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.

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