quality attribute specification
IRI: https://spec.industrialontologies.org/ontology/construct/QualityAttributeSpecification
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/
SubClass Of: output objective specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › objective specification › output objective specification › quality attribute specification
Direct subclasses:
Definition
output objective specification that prescribes some quality, capability, constitution, or composition that a material product or process intermediate material must possess in order to satisfy predefined quality requirements
Explanatory Notes
Attributes can be critical or not critical. In pharma criticality of an attribute is primarily based upon the severity of harm to the patient should the product fall outside the acceptable range for that attribute. Probability of occurrence, detectability, or controllability does not impact criticality of an attribute.
Usage Notes
These specifications may refer to intrinsic physical or chemical properties (such as pH or viscosity), to capabilities (such as binding affinity), or to the identity and proportion of distinguishable components (such as glycoforms, excipients, or host cell proteins). In cases where constitution or composition is relevant, the specification typically should be modeled as a quality that inheres in a continuant part of the material, such as the concentration or proportion of a specific component which is the ‘quality of’ (inheres in) that specific component.
Examples
- content uniformity specification; degradation product specification; residual solvent specification; drug release specification; dissolution specification; moisture content specification; microbial limit specification; color specification; shape specification; size specification; odor specification;
Counter-Examples
- Specification stating that purification yield must be ≥ 70% - This is a process performance constraint, not a specification for a quality of the product or process intermediate material.
Adapted From
- https://www.biophorum.com/wp-content/uploads/bp_downloads/CPV-Case-Study-Interactive-Version.pdf and https://pmc.ncbi.nlm.nih.gov/articles/PMC4070262/pdf/12248_2014_Article_9598.pdf
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs to create necessary and sufficient conditions. Specifically the constructs for predefined quality requirements are missing.
Formal Axioms
First-Order Logic Axioms
QualityAttributeSpecification(x) → OutputObjectiveSpecification(x) ∧ ∃q∃m((Quality(q) ∨ Capability(q)) ∧ (ProcessIntermediateMaterial(m) ∨ MaterialProduct(m)) ∧ ((∃z(MaterialEntity(z) ∧ continuantPartOfAtAllTimes(z, m) ∧ inheresIn(q, z))) ∨ inheresIn(q, m)) ∧ prescribes(x, q))
Semi-Formal Natural Language Axioms
if x is a ‘quality attribute specification’ then x is an ‘output objective specification’ that ‘prescribes’ some ‘quality’ or ‘capability’ q that either ‘inheres in’ some ‘process intermediate material’ or ‘material product’ m, or ‘inheres in’ some ‘material entity’ z that is a ‘continuant part of at all times’ m
Description Logic
constr:QualityAttributeSpecification ⊑ constr:OutputObjectiveSpecification
constr:QualityAttributeSpecification ⊑ ∃ constr:prescribes .((bfo:quality ⊔ constr:Capability) ⊓ ∃ bfo:inheres_in .(bfo:material_entity ⊓ ∃ bfo:continuant_part_of_at_all_times .(constr:MaterialProduct ⊔ constr:ProcessIntermediateMaterial))) ⊔ ∃ constr:prescribes .((bfo:quality ⊔ constr:Capability) ⊓ ∃ bfo:inheres_in .(constr:MaterialProduct ⊔ constr:ProcessIntermediateMaterial))
constr:QualityAttributeSpecification ⊓ constr:ProcessParameterSpecification ⊑ ⊥
SubClassOf: constr:OutputObjectiveSpecification
SubClassOf: constr:prescribes some ((bfo:quality or constr:Capability) and bfo:inheres_in some (bfo:material_entity and bfo:continuant_part_of_at_all_times some (constr:MaterialProduct or constr:ProcessIntermediateMaterial))) or constr:prescribes some ((bfo:quality or constr:Capability) and bfo:inheres_in some (constr:MaterialProduct or constr:ProcessIntermediateMaterial))
constr:QualityAttributeSpecification DisjointWith: constr:ProcessParameterSpecification