critical quality attribute identification process
IRI: https://spec.industrialontologies.org/ontology/construct/CriticalQualityAttributeIdentificationProcess
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 › critical quality attribute identification process
Definition
planned process that identifies critical quality attributes
Semi-Formal Definition:
every instance of ‘critical quality attribute identification process’ is defined as exactly an instance of ‘planned process’ that is ‘preceded by’ some ‘quality target product profile definition’, ‘has occurrent part’ some ‘risk assessment process’, and ‘has specified output’ some ‘critical quality attribute specification’
Explanatory Notes
1) Criticality of an attribute is primarily based upon the severity of harm to the patient should the product fall outside the acceptable range for that attribute. 2) Risk assessment is used as part of this process, which may leverage prior knowledge and increasing product and process understanding, making it iterative. Targeted experimentation may also be performed iteratively in conjunction with risk assessment.
Examples
- critical quality attribute (CQA) identification process for a monoclonal antibody drug product in which potency, purity, aggregate level, charge variants, glycosylation, and visible particles are evaluated for potential impact on safety, efficacy, or quality; critical quality attribute (CQA) identification process for a sterile injectable biologic in which sterility, endotoxin, particulate matter, potency, purity, and stability-related attributes are evaluated; critical quality attribute (CQA) identification process in which prior knowledge and risk assessment are used to determine which drug product quality attributes require control in the control strategy; critical quality attribute (CQA) identification process for a lyophilized drug product in which reconstitution time, residual moisture, potency, purity, appearance, and stability are evaluated;
Adapted From
- https://pmc.ncbi.nlm.nih.gov/articles/PMC4070262/ and https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf
Formal Axioms
First-Order Logic Definition
CriticalQualityAttributeIdentificationProcess(x) ↔ PlannedProcess(x) ∧ ∃q (precededBy(x, q) ∧ QualityTargetProductProfileDefinition(q)) ∧ ∃r (hasOccurrentPart(x, r) ∧ RiskAssessmentProcess(r)) ∧ ∃c (hasSpecifiedOutput(x, c) ∧ CriticalQualityAttributeSpecification(c))
Description Logic
constr:CriticalQualityAttributeIdentificationProcess ≡ constr:PlannedProcess ⊓ ∃ bfo:preceded_by .constr:QualityTargetProductProfileDefinition ⊓ ∃ bfo:has_occurrent_part .constr:RiskAssessmentProcess ⊓ ∃ constr:hasSpecifiedOutput .constr:CriticalQualityAttributeSpecification
constr:CriticalQualityAttributeIdentificationProcess ⊑ constr:PlannedProcess
EquivalentTo: constr:PlannedProcess and bfo:preceded_by some constr:QualityTargetProductProfileDefinition and bfo:has_occurrent_part some constr:RiskAssessmentProcess and constr:hasSpecifiedOutput some constr:CriticalQualityAttributeSpecification
SubClassOf: constr:PlannedProcess