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