material conformance specification

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

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

SubClass Of: requirement specification

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › requirement specification › material conformance specification

Definition

requirement specification that specifies tests and acceptance criteria for evaluating the acceptability of a material product, process intermediate material, raw material, or production consumable for a particular use

Explanatory Notes

1) Each listed test is intended to evaluate one or more attributes of the material, such as identity, purity, concentration, bioburden, endotoxin, or osmolality. A listed test references an analytical procedure that specifies how the relevant measurements are produced, while the associated acceptance criteria specify how those measurement or observation results are evaluated for conformance. 2) This specification type covers release, in-process, incoming or raw-material, and production-consumable acceptance specifications, provided they specify tests and acceptance criteria for evaluating the acceptability of the material for a stated use.

Examples

• drug substance release specification that includes identity, purity, potency, endotoxin, and bioburden tests and their acceptance criteria; in-process specification for a chromatography pool that includes protein concentration, purity, pH, conductivity, and bioburden tests and their acceptance criteria; incoming raw material specification for a media powder lot that includes identity, appearance, composition, moisture, impurity, and microbial tests and their acceptance criteria; prepared culture medium specification that includes pH, osmolality, appearance, endotoxin, bioburden, and cell-growth performance tests and their acceptance criteria

Synonyms

• Q6 Specification

Adapted From

• https://database.ich.org/sites/default/files/Q6B%20Guideline.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 a set of necessary and sufficient conditions.

Formal Axioms

First-Order Logic Axioms

MaterialConformanceSpecification(x) → RequirementSpecification(x) ∧ ∃p (hasContinuantPartAtAllTimes(x, p) ∧ PlanSpecification(p) ∧ ∃t (prescribes(p, t) ∧ MaterialTestingProcess(t))) ∧ ∃a (hasContinuantPartAtAllTimes(x, a) ∧ AcceptanceCriteria(a)) ∧ ∀y (requirementSatisfiedBy(x, y) → (MaterialProduct(y) ∨ ProcessIntermediateMaterial(y) ∨ ProductionConsumable(y) ∨ RawMaterial(y)))

Semi-Formal Natural Language Axioms

if x is a ‘material conformance specification’ then x is a ‘requirement specification’, x ‘has continuant part at all times’ some ‘plan specification’ that ‘prescribes’ some ‘material testing process’, x ‘has continuant part at all times’ some ‘acceptance criteria’, and x ‘requirement satisfied by’ only ‘material product’, ‘process intermediate material’, ‘production consumable’, or ‘raw material’

Description Logic

constr:MaterialConformanceSpecification ⊑ constr:RequirementSpecification

constr:MaterialConformanceSpecification ⊑ ∀ constr:requirementSatisfiedBy .(constr:MaterialProduct ⊔ constr:ProcessIntermediateMaterial ⊔ constr:ProductionConsumable ⊔ constr:RawMaterial)

constr:MaterialConformanceSpecification ⊑ ∃ bfo:has_continuant_part_at_all_times .constr:AcceptanceCriteria

constr:MaterialConformanceSpecification ⊑ ∃ bfo:has_continuant_part_at_all_times .(constr:PlanSpecification ⊓ ∃ constr:prescribes .constr:MaterialTestingProcess)

SubClassOf: constr:RequirementSpecification

SubClassOf: constr:requirementSatisfiedBy only (constr:MaterialProduct or constr:ProcessIntermediateMaterial or constr:ProductionConsumable or constr:RawMaterial)

SubClassOf: bfo:has_continuant_part_at_all_times some constr:AcceptanceCriteria

SubClassOf: bfo:has_continuant_part_at_all_times some (constr:PlanSpecification and constr:prescribes some constr:MaterialTestingProcess)