quality risk management process
IRI: https://spec.industrialontologies.org/ontology/construct/QualityRiskManagementProcess
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: risk management process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › risk management process › quality risk management process
Definition
risk management process that systematically performs risk assessment, risk control, risk communication, and risk review for risks to drug product quality across the product lifecycle
Explanatory Notes
Risks to drug product quality include risks arising from drug substances, raw materials, manufacturing processes, equipment, utilities, supply activities, and product availability issues caused by quality or manufacturing failures.
Examples
- quality risk management process for a monoclonal antibody manufacturing process in which risks to product quality from cell culture pH variability, nutrient feed errors, and harvest timing are assessed, controlled, communicated, and periodically reviewed across development and commercial manufacturing
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-r1-quality-risk-management-step-5-revision-2_en.pdf
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs present to create a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
QualityRiskManagementProcess(x) → RiskManagementProcess(x)
Semi-Formal Natural Language Axioms
if x is a ‘quality risk management process’ then x is a ‘risk management process’