material conformance testing process

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

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

SubClass Of: material testing process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › material testing process › material conformance testing process

Definition

material testing process that evaluates a material product, process intermediate material, raw material, or production consumable against acceptance criteria specified by a material conformance specification

Semi-Formal Definition:

every instance of ‘material conformance testing process’ is exactly an instance of ‘material testing process’ that ‘has input’ some ‘material conformance specification’ and ‘has input’ some entity that is a ‘material product’, ‘process intermediate material’, ‘production consumable’, or ‘raw material’

Examples

release testing of a drug substance batch against identity, purity, potency, endotoxin, and bioburden tests and their acceptance criteria; in-process testing of a chromatography pool against protein concentration, purity, pH, conductivity, and bioburden tests and their acceptance criteria; incoming testing of a culture media powder lot against identity, appearance, composition, moisture, impurity, and microbial tests and their acceptance criteria; testing of a prepared culture medium lot against pH, osmolality, appearance, endotoxin, bioburden, and cell-growth performance tests and their acceptance criteria

Adapted From

https://database.ich.org/sites/default/files/Q6B%20Guideline.pdf

Formal Axioms

First-Order Logic Definition

MaterialConformanceTestingProcess(x) ↔ MaterialTestingProcess(x) ∧ ∃s(MaterialConformanceSpecification(s) ∧ hasInput(x,s)) ∧ ∃m((MaterialProduct(m) ∨ ProcessIntermediateMaterial(m) ∨ ProductionConsumable(m) ∨ RawMaterial(m)) ∧ hasInput(x,m))