quality target product profile definition

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

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

SubClass Of: planned process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › quality target product profile definition

Definition

planned process in which a quality target product profile is established

Semi-Formal Definition:

every instance of ‘quality target product profile definition’ is defined as exactly an instance of ‘planned process’ that ‘has specified output’ some ‘quality target product profile’

Examples

• quality target product profile (QTPP) definition process for a sterile injectable monoclonal antibody drug product; quality target product profile (QTPP) definition process establishing target product quality characteristics for a lyophilized biologic; quality target product profile (QTPP) definition process for an oral solid dosage product that establishes desired dosage form, strength, dissolution, stability, and quality targets;

Adapted From

• https://pmc.ncbi.nlm.nih.gov/articles/PMC4070262/

Formal Axioms

First-Order Logic Definition

QualityTargetProductProfileDefinition(x) ↔ PlannedProcess(x) ∧ ∃q (hasSpecifiedOutput(x, q) ∧ QualityTargetProductProfile(q))

Description Logic

constr:QualityTargetProductProfileDefinition ≡ constr:PlannedProcess ⊓ ∃ constr:hasSpecifiedOutput .constr:QualityTargetProductProfile

constr:QualityTargetProductProfileDefinition ⊑ constr:PlannedProcess

EquivalentTo: constr:PlannedProcess and constr:hasSpecifiedOutput some constr:QualityTargetProductProfile

SubClassOf: constr:PlannedProcess