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 me 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 “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’ and x ‘prescribes’ some ‘quality’ or ‘capability’ that ‘inheres in’ either: some ‘material entity’ that is ‘continuant part of at all times’ some ‘process intermediate material’ or ‘material product’, or that same ‘process intermediate material’ or ‘material product

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:ProcessIntermediateMaterial ⊔ constr:MaterialProduct))) ⊔ ∃ constr:prescribes .((bfo:quality ⊔ constr:Capability) ⊓ ∃ bfo:inheres_in .(constr:ProcessIntermediateMaterial ⊔ constr:MaterialProduct))

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:ProcessIntermediateMaterial or constr:MaterialProduct))) or constr:prescribes some ((bfo:quality or constr:Capability) and bfo:inheres_in some (constr:ProcessIntermediateMaterial or constr:MaterialProduct))

constr:QualityAttributeSpecification DisjointWith: constr:ProcessParameterSpecification