out of specification assessment
IRI: https://spec.industrialontologies.org/ontology/construct/OutOfSpecificationAssessment
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterialTesting/
SubClass Of: material test assessment
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › material test assessment › out of specification assessment
Definition
material test assessment that records that one or more measurement results do not meet the acceptance criteria specified by an applicable material conformance specification
Explanatory Notes
Applicable material conformance specifications may include specifications established in drug applications, drug master files, official compendia, or by the manufacturer, including specifications for in-process laboratory testing.
Examples
- an out-of-specification assessment recording that a drug-substance potency result of 91.8% is below the lower acceptance limit of 95.0% specified by the applicable release specification; an out-of-specification assessment recording that a bioburden result of 14 CFU/100 mL exceeds the upper acceptance limit of 10 CFU/100 mL specified for an in-process chromatography pool; an out-of-specification assessment recording that the osmolality of a prepared culture-medium lot exceeds the upper acceptance limit of 320 mOsm/kg; an out-of-specification assessment recording that the infrared spectrum obtained during identity testing of a media powder lot does not meet the specified identity acceptance criterion;
Adapted From
- https://www.fda.gov/media/158416/download
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
OutOfSpecificationAssessment(x) → MaterialTestAssessment(x) ∧ ∃a∃s(AcceptanceCriteria(a) ∧ MaterialConformanceSpecification(s) ∧ continuantPartOfAtAllTimes(a,s) ∧ isAbout(x,a))
Semi-Formal Natural Language Axioms
if x is an ‘out of specification assessment’ then x is a ‘material test assessment’ that ‘is about’ some ‘acceptance criteria’ that are a ‘continuant part of at all times’ some ‘material conformance specification’
Description Logic
constr:OutOfSpecificationAssessment ⊑ constr:MaterialTestAssessment
constr:OutOfSpecificationAssessment ⊑ ∃ constr:isAbout .(constr:AcceptanceCriteria ⊓ ∃ bfo:continuant_part_of_at_all_times .constr:MaterialConformanceSpecification)
SubClassOf: constr:MaterialTestAssessment
SubClassOf: constr:isAbout some (constr:AcceptanceCriteria and bfo:continuant_part_of_at_all_times some constr:MaterialConformanceSpecification)