material quality plan
IRI: https://spec.industrialontologies.org/ontology/construct/MaterialQualityPlan
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMonitoringAndControl/
SubClass Of: plan specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › plan specification › material quality plan
Direct subclasses:
Definition
plan specification that prescribes the processes needed to ensure that a raw material, process intermediate material, material product, or production consumable meets the required quality objectives
Examples
- A material 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; A material quality plan for incoming acetaminophen API prescribes supplier approval, receipt inspection, quarantine, CoA review, identity and composite QC testing, release criteria, status labeling, and batch documentation to ensure suitability before tablet production.
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 quality plan
Formal Axioms
First-Order Logic Axioms
MaterialQualityPlan(x) → PlanSpecification(x)
Semi-Formal Natural Language Axioms
if x is a ‘material quality plan’ then x is a ‘plan specification’