Biopharma Parameter Ontology

Maturity: 🟢 Released

IRI: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/

This module contains terms and relations necessary for representing process intermediate and product quality attributes, process indicators and process parameters.

Classes (17)

Class Definition
critical process parameter process profile or temporal region or quality prescribed by a critical process parameter specification
critical process parameter specification process parameter specification that prescribes a variable which has an impact on a critical quality attribute
critical quality attribute quality or capability prescribed by a critical quality attribute specification
critical quality attribute specification quality attribute specifications that prescribes some quality, capability, constitution, or composition deemed critical to ensurin…
key performance indicator process profile, temporal region, quality or process characteristic prescribed by a key performance indicator specification
key performance indicator specification performance indicator specification that prescribes a measurable characteristic whose measurements reflect effectiveness with resp…
key process parameter process profile or temporal region or quality prescribed by a key process parameter specification
key process parameter specification process parameter specification that prescribes a variable which must be tightly controlled to ensure process consistency and that…
normal operating range value expression value expression that is a range around a set point within which a particular process parameter is expected to vary during normal …
performance indicator process profile, temporal region, quality or process characteristic prescribed by a performance indicator specification
performance indicator specification information content entity that prescribes some measurable characteristic whose measurements reflect the effectiveness of an agent…
process parameter process profile or temporal region or quality prescribed by a process parameter specification
process parameter specification information content entity that prescribes a monitorable or controllable variable associated with some planned process
proven acceptable range value expression value expression range that has been validated through testing or documented experience and that is a prescribed range within whic…
quality attribute quality or capability that is prescribed by a quality attribute specification
quality attribute specification output objective specification that prescribes some quality, capability, constitution, or composition that a material product or p…
setpoint value expression value expression which is a prescribed value that a process parameter should have at a particular time point or during a particula…

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