quality attribute
- Guideline or reference source
- ICHQ5E comparability of biotechnological/biological products
- Definition
- A molecular or product characteristic that is selected for its ability to help indicate the quality of the product. Collectively, the quality attributes define identity, purity, potency and stability of the product, and safety with respect to adventitious agents. Specifications measure a selected subset of the quality attributes.
- Broader Term
- quality
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