quality attribute

IRI: https://spec.industrialontologies.org/ontology/construct/QualityAttribute

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/

SubClass Of: bfo:specifically dependent continuant

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › quality attribute

Direct subclasses:

• critical quality attribute

Definition

quality or capability that is prescribed by a quality attribute specification

Semi-Formal Definition:

every instance of ‘quality attribute’ is defined as exactly an instance of ‘quality’ or ‘capability’ that is ‘prescribed by’ some ‘quality attribute specification’

Explanatory Notes

See the expanded definition under the corresponding specification class. The term is formalized here as a defined class by referring to its corresponding specification class and exists primarily for ontological modeling and implementation convenience.

Examples

• content uniformity of the dosage units in a batch; level of degradation products in the formulation; residual solvent level in the final product; rate or extent of drug release; dissolution capability dosage form; moisture content of the drug product; microbial load in the final product; color of the tablet or capsule; shape of the dosage form; size of the finished unit; odor of the drug product;

Counter-Examples

• yield of the protein purification step

Formal Axioms

First-Order Logic Definition

QualityAttribute(x) ↔ (Quality(x) ∨ Capability(x)) ∧ ∃s(QualityAttributeSpecification(s) ∧ prescribedBy(x, s))

Description Logic

constr:QualityAttribute ≡ (bfo:quality ⊔ constr:Capability) ⊓ ∃ constr:prescribedBy .constr:QualityAttributeSpecification

constr:QualityAttribute ⊑ bfo:specifically_dependent_continuant

EquivalentTo: (bfo:quality or constr:Capability) and constr:prescribedBy some constr:QualityAttributeSpecification

SubClassOf: bfo:specifically_dependent_continuant