critical process parameter specification

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

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

SubClass Of: process parameter specification

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › process parameter specification › critical process parameter specification

Definition

process parameter specification that prescribes a variable which has an impact on a critical quality attribute

Explanatory Notes

FROM ICH: process parameter specification whose variability has an impact on a critical quality attribute and, therefore, should be monitored or controlled to ensure the process obtains the desired quality

Examples

• pH specification for the viral inactivation process, due to its impact on the viral clearance capability of the intermediate; temperature specification for the fermentation process, which affects product titer and impurity levels; agitation speed specification for the cell culture mixing step, where excessive shear stress can impact cell viability and product quality;

Adapted From

• https://database.ich.org/sites/default/files/Q8%28R2%29%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 have a set of necessary and sufficient conditions. In particular criticality determination is missing as well as a more semantically specific connection to a critical quality attribute specification

Formal Axioms

First-Order Logic Axioms

CriticalProcessParameterSpecification(x) → ProcessParameterSpecification(x) ∧ ∃y (CriticalQualityAttributeSpecification(y) ∧ isAbout(x, y))

Semi-Formal Natural Language Axioms

if x is a ‘critical process parameter specification’ then x is a ‘process parameter specification’ and x ‘is about’ some ‘critical quality attribute specification’

Description Logic

constr:CriticalProcessParameterSpecification ⊑ constr:ProcessParameterSpecification

constr:CriticalProcessParameterSpecification ⊑ ∃ constr:isAbout .constr:CriticalQualityAttributeSpecification

constr:CriticalProcessParameterSpecification ⊓ constr:KeyProcessParameterSpecification ⊑ ⊥

SubClassOf: constr:ProcessParameterSpecification

SubClassOf: constr:isAbout some constr:CriticalQualityAttributeSpecification

constr:CriticalProcessParameterSpecification DisjointWith: constr:KeyProcessParameterSpecification