material product quality plan
IRI: https://spec.industrialontologies.org/ontology/construct/MaterialProductQualityPlan
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMonitoringAndControl/
SubClass Of: material quality plan
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › plan specification › material quality plan › material product quality plan
Definition
material quality plan that prescribes the processes needed to ensure that a material product meets the required quality objectives
Explanatory Notes
1) At least one process prescribed by some part of the quality plan has to be a measurement process 2) The processes embedded in the quality plan typically include testing, inspection, characterization 3) The material product quality plan typically embeds the processes done to ensure quality of intermediates and not just the final products
Examples
- A material product quality plan for a particular chromatography resin prescribes synthesis process controls, intermediate and final QC testing, and release criteria to ensure the resin meets defined binding capacity, particle size distribution, and metal impurity limits. It includes in-process monitoring of pH and temperature during functionalization, validated leachables testing, and visual inspection.
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs in this release to fully capture the structure of a material product quality plan
Formal Axioms
First-Order Logic Axioms
MaterialProductQualityPlan(x) → MaterialQualityPlan(x) ∧ ∃a (PlanSpecification(a) ∧ hasContinuantPartAtAllTimes(x, a) ∧ ∃m (MeasurementProcess(m) ∧ prescribes(a, m))) ∧ ∃q (QualityAttributeSpecification(q) ∧ hasContinuantPartAtAllTimes(x, q)) ∧ ∃p∃pp (PlannedProcess(p) ∧ ProductProductionProcess(pp) ∧ prescribes(x, p) ∧ (precededBy(p, pp) ∨ occurrentPartOf(p, pp) ∨ isTemporallyOverlappedBy(p, pp)))
Semi-Formal Natural Language Axioms
if x is a ‘material product quality plan’, then x is a ‘material quality plan’ that ‘has continuant part at all times’ some ‘plan specification’ a that ‘prescribes’ some ‘measurement process’, ‘has continuant part at all times’ some ‘quality attribute specification’, and ‘prescribes’ some ‘planned process’ p that is ‘preceded by’, is an ‘occurrent part of’, or ‘is temporally overlapped by’ some ‘product production process’
Description Logic
constr:MaterialProductQualityPlan ⊑ constr:MaterialQualityPlan
constr:MaterialProductQualityPlan ⊑ ∃ bfo:has_continuant_part_at_all_times .constr:QualityAttributeSpecification
constr:MaterialProductQualityPlan ⊑ ∃ bfo:has_continuant_part_at_all_times .(constr:PlanSpecification ⊓ ∃ constr:prescribes .constr:MeasurementProcess)
constr:MaterialProductQualityPlan ⊑ ∃ constr:prescribes .(constr:PlannedProcess ⊓ (∃ bfo:preceded_by .constr:ProductProductionProcess ⊔ ∃ bfo:occurrent_part_of .constr:ProductProductionProcess ⊔ ∃ constr:isTemporallyOverlappedBy .constr:ProductProductionProcess))
SubClassOf: constr:MaterialQualityPlan
SubClassOf: bfo:has_continuant_part_at_all_times some constr:QualityAttributeSpecification
SubClassOf: bfo:has_continuant_part_at_all_times some (constr:PlanSpecification and constr:prescribes some constr:MeasurementProcess)
SubClassOf: constr:prescribes some (constr:PlannedProcess and (bfo:preceded_by some constr:ProductProductionProcess or bfo:occurrent_part_of some constr:ProductProductionProcess or constr:isTemporallyOverlappedBy some constr:ProductProductionProcess))